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As Europe has been significantly impacted by the Covid-19 pandemic, a substantial amount of clinical research is currently focused on identifying effective therapies and vaccines. GlobalData analysed the Covid-19 clinical trials landscape in Europe with a view to identifying key trial-related trends. The greatest proportion of European Covid-19 clinical trials are in the Phase II stage of development (43.3%), narrowly outnumbering Phase III trials (38.4%). Phase IV clinical trials (12.6%) outnumber Phase I studies, which account for the smallest proportion of trials (5.6%).

The Phase distribution of clinical trials suggests sponsors are focusing primarily on repurposing available therapies as opposed to working solely with investigational medicinal products (IMPs). Given the imminent threat to life posed by Covid-19, this is to be expected. Notably, the top six countries with the highest number of clinical trials also have the greatest number of Covid-19 cases in Europe, thereby highlighting that level of research directly correlates with the clinical need for effective therapies. As shown in Figure 1, the UK dominates the Covid-19 research space, accounting for the highest number of clinical trials (24.5%), followed by Spain (13.2%), France (9.5%), Italy (5.3%), Russia (4.8%), and Germany (3.8%).

Assistance Publique – Hopitaux de Paris is the top sponsor with 4.7% of European Covid-19 trials, more than double that of the University of Oxford, which sponsors the second largest number of trials (2.3%). Assistance Publique – Hopitaux de Paris utilises a range of therapy types in its studies, but it appears to have a focus on monoclonal antibodies as a treatment option for Covid-19.

Research efforts by the University of Oxford are mainly focused on finding a viable vaccine. The institute has co-partnered with AstraZeneca to develop the Covid-19 vaccine AZD1222. While efficacy results are yet to be published, a Phase III study is underway and production capacity has been up-scaled, suggesting there have been positive findings concerning safety and efficacy in the early phase trials.

Despite mixed data form the hydroxychloroquine studies and several studies being terminated, new trials using hydroxychloroquine with or without additional drugs continue to expand. It is the most widely used drug in Covid-19 trials worldwide and trials in Europe follow the same trend, with 14.4% of all European Covid-19 trials investigating the agent, more than double that of second-place tocilizumab (6.3%), as displayed by Figure 2. A Phase III study sponsored by the IHU-Mediterranee Infection in France had shown hydroxychloroquine to be effective in reducing the Covid-19 viral load, with its effect reinforced by azithromycin. This trial has gained significant media attention despite having several limitations in its trials, including sample size.

One of the largest Covid-19 clinical trials (RECOVERY) in Europe, which is sponsored by the University of Oxford, is investigating hydroxychloroquine as a therapy. However, the hydroxychloroquine arm halted enrolment after a review of the data showed that the treatment provided no viable benefits on mortality, disease course, or hospital stay. The RECOVERY trial had a vastly greater patient population, giving more credence to the results as compared with the earlier IHUMediterranee.

Recently, the Medicines and Healthcare Products Regulatory Agency (MHRA) has announced that it is instructing companies and organizations sponsoring UK clinical trials involving the use of hydroxychloroquine in Covid-19 to suspend the enrolment of patients. The MHRA decision stems from a review of the latest available data, including the RECOVERY trial, in which hydroxychloroquine provided no viable benefits in hospitalised patients. Furthermore, FDA has revoked hydroxychloroquine’s Emergency Use Authorization on the basis of current evidence which determined that the drug does not display adequate effectiveness in treating Covid-19, so the benefits of taking hydroxychloroquine do not outweigh the risks. It is therefore expected that a significant decline in the number of new trials investigating hydroxychloroquine as a Covid-19 therapy will occur. This is supported by the manner in which 71.4% of all Suspended, Terminated, or Withdrawn trials involve hydroxychloroquine.

Interestingly, researchers from the RECOVERY trial announced one of the other therapies being investigated, dexamethasone, has been shown to reduce the risk of death in patients on ventilators by one-third and reduce the risk of deaths on patents on oxygen by one-fifth. The new findings demonstrate the importance of the RECOVERY trial in identifying which treatments are or are not effective.

The significant amount of research effort across Europe signifies a shared goal in the search for effective therapies. Nevertheless, only 5.2% of trials have announced some form of efficacy results, which suggests the research is still in the early stages, and a continuation in a global effort is required to identify effective treatments to address the urgent need for effective therapies.

One month after Vaxart announced the selection of its lead vaccine candidate for COVID-19, the Bay Area-based company said it has been selected to participate in the U.S. government’s Operation Warp Speed program.

The South San Francisco company said this morning that its oral COVID-19 vaccine has been selected to participate in a non-human primate (NHP) challenge study, which was organized by the federal program that has a goal of developing hundreds of millions of doses of vaccines to protect against COVID-19, which has infected more than 9.6 million people across the globe and 2.4 million in the United States. The government’s goal is to identify the most promising vaccine candidate while it is still under development and provide as much support as possible in order to move it through the clinical and regulatory process in order to have it available for the public.  

Vaxart Chief Executive Officer Andrei Floroiu, who took over the top spot of the company earlier this month, said he was pleased the company was selected to participate in Operation Warp Speed. Vaxart’s vaccine candidate is one of a handful of potential preventative drugs selected by the government for additional funding and study. The Vaxart candidate, which is scheduled to begin clinical studies before the end of this year, stands alongside vaccine candidates from Moderna, AstraZeneca, Johnson & Johnson and other companies in the fight against the global pandemic. Moderna announced its plans to launch a Phase III study of its vaccine candidate within the next few weeks and AstraZeneca’s vaccine candidate, which is under development with the Jenner Institute at Oxford University, is currently in a Phase II/III study. Johnson & Johnson announced its intentions to enter the clinic in the second half of July with a Phase I/IIa study.

Vaxart initiated preclinical studies for a COVID-19 vaccine in January following reports of the outbreak’s spread across the globe. The candidate is based on the company’s VAASTT oral vaccines platform, which uses adenovirus type 5 (Ad5) as a delivery system for its treatment. In that first round of preclinical testing, all animals that received one of the Vaxart vaccines had IgG anti-SARS CoV-2 antibodies in serum two weeks after the first vaccination.  Antibody responses in all vaccinated groups were statistically significant compared to the untreated controls, the company noted at the time.

“SARS-CoV-2, the coronavirus that causes COVID-19, is primarily transmitted by viral particles that enter through the mucosa – nose, mouth or eyes – strongly suggesting that mucosal immunity could serve as the first line of defense,” Floroiu said in a statement.

Floroiu said the company’s vaccine candidate is a room temperature-stable tablet, which provides the company with an enormous advantage in shipping the vaccine to areas that may not have ample refrigeration capabilities.

Earlier this year, Vaxart entered a development agreement with Emergent BioSolutions Inc. to prepare for cGMP production of the oral COVID-19 vaccine. Emergent BioSolutions also signed an agreement with AstraZeneca to support its vaccine candidate.

Yumanity Therapeutics and Merck signed a strategic research and license deal for two Yumanity programs. The two preclinical programs are for amyotrophic lateral sclerosis (ALS) and frontotemporal lobar dementia (FTLD).

Under the terms of the agreement, Merck gains exclusive rights to two novel Yumanity pipeline programs. Yumanity will be paid an upfront fee and will be eligible for milestone payments totaling about $500 million in addition to royalties on net sales. Merck is also joining existing Yumanity investors in a Series C financing round. The existing investors include Fidelity Management & Research Company, Redmile Group, Pfizer Ventures, Alexandria Venture Investments, Tony Coles, and Dolby Family Ventures.

“We are excited to collaborate with the Merck neuroscience team focused on the goal of bringing novel therapeutic options to ALS and FTLD patients,” said Richard Peters, chief executive officer of Yumanity. “This alliance reflects our shared commitment to neurodegenerative diseases that continue to have high unmet need. We look forward to a productive collaboration.”

ALS, also known as Lou Gehrig’s disease, is a progressive neurodegenerative disorder affecting nerve cells in the brain and the spinal cord. The progressive degeneration of the motor neurons in ALS eventually kills the neurons. When that happens, the brain is unable to initiate and control muscle movement, which can lead to the loss of ability to speak, eat, move and breathe.

FTLD is an umbrella term for a family of uncommon brain disorders of the frontal and temporal lobes of the brain. These brain areas are typically associated with personality, behavior and language. In frontotemporal dementia, parts of these lobes shrink. Depending on which part of the brain is affected, they can see dramatic personality changes, becoming socially inappropriate, impulsive or emotionally indifferent. Other patients lose the ability to use language properly. It is often misdiagnosed as Alzheimer’s disease or a psychiatric problem. Frontotemporal dementia generally occurs at a younger age than Alzheimer’s, beginning between the ages of 40 and 65.

These are both areas of significant unmet medical need. ALS is projected to grow in the world’s seven most mature pharmaceutical markets by 21% over the next 20 years because of an aging population, according to DRG, a division of Clarivate.

Both of the Yumanity programs target protein misfolding. Yumanity will handle the preclinical research, then Merck will take them into the clinic and handle commercialization activities.

Yumanity’s basic research derived from the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology. It came out of the lab of late company co-founder Susan Lindquist and identifies molecules using phenotypic screens to identify compounds that can overcome the toxicity of the misfolded proteins in brain cells. They then test the compounds using brain cells evolved from stem cells created from skin biopsies from donors with the specific diseases.

The company’s approach may lead to approaches to other neurodegenerative diseases, such as Parkinson’s disease, the focus of its lead internal candidate YTX-7739 and Alzheimer’s disease. The company also has another program for Lewy Body dementia it hopes to advance into the clinic in 2021.

“There remains tremendous unmet medical need for the treatment of patients with amyotrophic lateral sclerosis and frontotemporal lobar dementia,” said Fiona Marshall, vice president of Neuroscience Discovery, Merck Research Laboratories. “We look forward to working with scientists at Yumanity to advance research and evaluate the potential for therapeutic intervention in these neurodegenerative diseases.”

Other companies working on protein misfolding include Prothena Corp., which has several partnered programs, including prasinezumab, which it is developing with Roche for Parkinson’s and other related synucleinopathies. Prothena also has programs focused on tau with Bristol Myers Squibb for Alzheimer’s, ALS, frontotemporal dementia and other neurodegenerative diseases. Biogen, Takeda Pharmaceutical and AbbVie are also working on programs that target misfolding of alpha-synuclein in Parkinson’s.

“What this field needs, in neurodegeneration, is new ways of attacking these diseases,” said Peters, to BioWorld. “Yumanity was founded to do just that.”

Shares of Fulcrum Therapeutics were up more than 14% in premarket trading after the company announced it will begin the Phase LOSVID III study to assess losmapimod as a potential treatment of COVID-19.

This morning Cambridge, Mass.-based Fulcrum said the U.S. Food and Drug Administration approved an investigational New Drug Application to test losmapimod in a placebo-controlled late-stage study that will 400 hospitalized adults with COVID-19. FDA approval was swift. Fulcrum announced its plansto seek approval for the study two weeks ago, the same day the company announced it secured $68.5 million from a private placement that will fund this study, as well as ongoing clinical research of losmapimod for facioscapulohumeral muscular dystrophy.

Losmapimod is a selective p38α/β mitogen-activated protein kinase (MAPK) inhibitor that may impact multiple components of COVID-19. Robert J. Gould, president and chief executive officer of Fulcrum, said the company believes losmapimod has the potential to be a differentiated treatment option in the global fight against COVID-19. Preclinical and clinical studies indicate that losmapimod has the potential to reduce the acute exaggerated pro-inflammatory responses to SARS-CoV-2 infection and restore the antigen-specific immune responses that are needed to clear the virus. In previous clinical trials in chronic inflammatory conditions, losmapimod had an immediate effect on a number of inflammatory biomarkers that have been associated with poor prognosis in COVID-19, including C-reactive protein and interleukin-6, Fulcrum said in its announcement.  

“The speed with which we have advanced this program reflects our deep understanding of the mechanism of action of losmapimod, the pressing need for treatment options and the commitment of our team to develop therapies that result in meaningful outcomes for patients. We are encouraged by the feedback we have received from investigators, and we expect to have all sites participating in the trial to be activated in the coming weeks,” Gould said in a statement.

The Phase III LOVIS study will assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod compared to placebo for 14 days on top of standard of care in approximately 400 patients hospitalized with COVID-19 and at risk of progression to critical illness. The primary endpoint will be the proportion of patients who progress to death or respiratory failure by day 28 following initiation of treatment. Secondary endpoints include clinical status on days seven and 14, total number of days free of oxygen supplementation, all-cause mortality, length of hospitalization and ICU stay and viral clearance. Fulcrum expects to present an interim analysis of results in the fourth quarter of 2020 and topline data is expected to be reported in the first quarter of 2021.

Robert Finberg, a professor of medicine at the University of Massachusetts Medical School, said studies indicate that p38 inhibition can decrease inflammatory responses but enhance T-cell responses to a viral antigen. These results suggest that losmapimod could improve the pathology of COVID-19 in multiple ways, he said.

“Losmapimod is a promising treatment candidate that could address multiple key contributors to the pathogenesis of COVID-19 and already has an extensive amount of safety and tolerability data across multiple age groups, including the elderly. The rapid initiation of this pivotal trial reflects the data supporting this research and the pressing need for effective therapies that reduce the morbidity associated with COVID-19,” Finberg said.

New information released Tuesday by GlobalData showed that there are now more than 718 pipeline drugs associated with COVID-19. In addition, 70% of these products are in the discovery or preclinical stages.

“These drugs include combinations of novel agents and repurposed drugs, and new ones are added daily as new studies are announced or completed at a rapid rate,” said Johanna Swanson, product manager at GlobalData.

According to the most recent statistics, there are more than 2,000 clinical trials being conducted around the world, with 398 of them focused on chloroquine or hydroxychloroquine. A total of 22 of them are trials looking into remdesivir, an investigational drug that is still being examined by the U.S. Food and Drug Administration (FDA) for use in patients.

Gilead Sciences released new data on June 1 from its Phase III SIMPLE trial, examining remdesivir and how it can potentially help hospitalized COVID-19 patients with moderate pneumonia. The open-label study evaluated five-day and 10-day courses of remdesivir when used with standard care, versus standard care alone.

Statistics from the Phase III SIMPLE trial showed that patients in the five-day remdesivir treatment group were 65% more likely to show clinical improvement at Day 11, compared to their counterparts. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard care alone were also favorable. However, they did not show statistical significance.

“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School. “These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients.”

On June 15, the FDA issued a new warning to healthcare providers pertaining to a new drug interaction related to remdesivir, which had received emergency use authorization for the treatment of hospitalized COVID-19 patients. The FDA revised its fact sheet for healthcare providers to reflect the potential interactions between remdesivir and chloroquine phosphate or hydroxychloroquine sulfate – the co-administration of remdesivir with these products may reduce the antiviral activity of the drug, according to the FDA.

The FDA is not aware of any instances of this reduced activity occurring in a clinical setting, but is continuing to evaluate the use of remdesivir and all data surrounding the drug.

“Over the course of this unprecedented pandemic, the FDA has issued emergency use authorizations for a variety of medical products after evaluating the available scientific evidence and carefully balancing any known or potential risks against the benefits of making these products available during the current public health emergency,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “We understand that, as we learn more about these products, changes may be necessary based on new data – such as today’s updates for health care providers about a potential drug interaction and other important information about using remdesivir to treat COVID-19 patients. As we have done throughout the pandemic, the FDA continues to evaluate all of the emergency use authorizations issued and their related materials and will continue to make changes as appropriate based on emerging science and data.”

As the COVID-19 pandemic ramped up in March, April and May around the globe, numerous clinical trials for other diseases were paused in order to free up clinics and hospitals as well as to decrease the risk to patients. If companies were able to do so or the disease being studied was critical, trials continued or changes were made to improve access, such as televisits and other approaches.

According to a BioPharma Dive report, since March, more than 100 biopharma companies announced their clinical trials were disrupted in some way because of the pandemic.

Today, the European Pharmaceutical Review reported a GlobalData study that found more than 200 clinical trials that had been disrupted are now ongoing or completed. This is a 3.2-times increase compared to May.

“The number of disrupted clinical trials and organizations has continued to grow over the last three months,” said Brooke Wilson, associate director of Trials Intelligence at GlobalData. “This trend is most noticeable between April and May but has begun to slow. Suspension of enrollment accounted for 61.5% of the disruptions. Over all three months, 14% of the disrupted clinical trials are specifically pivotal/registrational, giving an indication that there will be an impact on regulatory approvals in the future.”

It’s difficult to say how the disruptions will ultimately impact drug approvals. A CNBC report suggests that for the U.S. Food and Drug Administration (FDA), the near-term impact could mean a backlog once biopharma companies finish their trials and submit their New Drug Applications (NDAs), according to analysts.

“You might see a burst of activity start to hit the regulatory authorities,” said former FDA Commissioner Scott Gottlieb, who is now a board member of Pfizer, Tempus and Illumina. “The agency has been keeping up,” so far, he added.

The last set of delays for the agency was during the partial government shutdown in early 2019. The shutdown was related to a battle over President Donald Trump’s demand for a border wall between U.S. and Mexico. The FDA continued many operations but furloughed about half its workforce and stopped accepting NDAs or fees.

Gottlieb, who ran the agency at that time, said, “We were able to keep up with it, but [the shutdown] was only a month, month and a half.”

During the pandemic, the agency has appeared to keep up quite well with approvals overall while shifting many of its resources toward COVID-19.

“With many staff members working on COVID-19 activities, it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely,” the FDA wrote in a May 26 document.

In response, FDA created a website specifically to assist biopharma companies with clinical trials. CNBC questioned the agency about a potential bottleneck and the FDA said it continues to “perform our medical product review activities as well as contribute to other vital functions of the agency.”

An FDA spokesperson added, “We are working around the clock to monitor and mitigate emerging coronavirus-related issues with our federal partners, international regulators, and medical product developers and manufacturers to advance response efforts to combat the coronavirus disease (COVID-19) outbreak. Our application review teams remain focused on their work, and we are doing everything possible to maintain continuity of operations in a very dynamic situation and will continue to be flexible and as transparent as possible.”

Some experts believe that specific areas, such as cancer and rare diseases, which are a high priority for the FDA, will likely remain on track. Other areas, such as generic drugs, and possibly medical devices, may be slower.

“There’s definitely some lingering concerns about FDA reviews taking a little bit longer,” said Mike Bailey, director of research at FBB Capital Partners and a former healthcare analyst at Stifel. “Especially for medical devices. … That is a whole another layer because of the COVID delays.”

Brian Skorney, an analyst at Robert W. Baird & Co. expects delays down the road “as we see a need for the FDA to evaluate clinical trial data in a background where participants may be dropping out of studies or a much larger number of data points in a study will be missing.”

But Skorney doesn’t think major drug advances will be delayed, although there is a possibility in the U.S. we “could see a slowdown in approvals for marginally effective drugs because of prioritization. How much of a headwind this becomes for the industry will probably be determined by how COVID spread occurs over the next few months. A major spike would slow things down more and a successful reopening without a major rebound in cases would probably see a very limited impact on regulatory approvals.”

Merck’s investigational pneumonia vaccine, V114, hit the mark in two Phase III studies, including one involving adult HIV patients.

V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, was assessed in two late-stage studies. The PNEU-WAY trial studied the vaccine in adults with HIV, as well as the PNEU-FLU program. In the PNEU-WAY study, V114 elicited an immune response to all 15 serotypes included in the vaccine, and in PNEU-FLU, the study showed V114 can be given concomitantly with the quadrivalent influenza vaccine. Results from these studies, as well as a study evaluating Pneumovax 23 (Pneumococcal Vaccine Polyvalent) were published in the online digital library of the International Symposium on Pneumococci and Pneumococcal Diseases.

Luwy Musey, executive director in biologics, vaccine clinical research at Merck Research Laboratories, said the results of the two Phase III studies are encouraging. He said the company plans to share additional data from the other ongoing 14 V114 programs in the future. Those programs include pivotal studies assessing the immunogenicity of V114 and its potential to protect against the serotypes most likely to cause invasive disease.

During a virtual press briefing on the results, Musey said he looks forward to seeing how the vaccine candidate can positively impact this disease worldwide.

The V114 clinical development program includes 16 trials investigating the safety, tolerability and immunogenicity of V114 in a number of populations who are at increased risk for pneumococcal disease including both healthy older adult and healthy pediatric populations. The studies also include people who are immunocompromised or have certain chronic conditions.

In the PNEU-WAY study, Merck studied the use of V114 followed by Pneumovax 23 in HIV patients compared to the currently available 13-valent pneumococcal conjugate vaccine and Pneumovax 23. Merck said V114 met its primary immunogenicity objective as measured by serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) and Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for all 15 serotypes contained in the vaccine 30 days after administration. The OPA GMTs and IgG GMCs for the 13 shared serotypes between V114 and PCV13 were generally comparable between the two groups, but, immune responses were higher in the V114 group compared with the PCV13 group for the two serotypes unique to V114, 22F and 33F, which are commonly associated with invasive pneumococcal disease worldwide, Merck said.

In the PNEU-FLU study, patients were randomized to receive either V114 and the quadrivalent influenza vaccine (QIV) or placebo combined with the quadrivalent influenza vaccine. Merck said the study met both primary immunogenicity objectives. V114 was noninferior based on serotype-specific OPA GMTs at 30 days post-vaccination. Additionally, QIV administered concomitantly with V114 was noninferior to QIV administered non-concomitantly with V114, based on the influenza strain-specific hemagglutination inhibition (HAI) GMTs at 30 days post-vaccination with QIV, Merck said.

Shares of Evelo Biosciences were up more than 25% in premarket trading after the company announced its investigational asset EDP1815 will be included in the Phase II/III TACTIC-E COVID-19-focused clinical trial for conducted by Cambridge University Hospitals NHS Foundation Trust.

The TACTIC-E trial will investigate the safety and efficacy of experimental therapies designed to prevent and treat life-threatening complications associated with COVID-19 in hospitalized patients who are at early stages of the disease. The study will enroll COVID-19 patients who have identified risk factors that could lead to their developing severe complications, which put them at risk of being placed in an intensive care unit or lead to death. There is a strong focus on modulating the immune response, given that progression to severe COVID-19 is associated with hyperinflammation and cytokine storm. Evelo’s EDP1815 was selected for this study following data from a Phase Ib psoriasis study that showed the medication has the ability to modulate multiple inflammatory pathways.

In a Phase Ib clinical trial in psoriasis, EDP1815 limited the production of multiple inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1b. It was well tolerated with no overall difference from placebo. In preclinical models, EDP1815 also resolved inflammation across TH1, TH2, and TH17 pathways, Evelo noted. EDP1815 acts on cells in the lining of the small intestine and triggers signals which act throughout the body, even though the investigational drug has not been observed to leave the gut or circulate around the body, Evelo added.

Joseph Cheriyan, Consultant Clinical Pharmacologist at Addenbrooke’s Hospital in Cambridge England and the lead investigator of the TACTIC-E study, said EDP1815 was selected for the trial given the tolerability and the modulation of multiple inflammatory pathways observed in that Phase Ib study.

Mark Bodmber, Evelo’s chief scientific officer, said the recent results from a study of the steroid dexamethasone suggest that an oral treatment like EDP1815, which has potential broad anti-inflammatory effects, could prevent severe complications by COVID-19. The U.K. study regarding dexamethasone showed the drug only demonstrated efficacy in 30% of critically ill patients.

“EDP1815 has the potential to address the complex inflammatory chaos associated with cytokine storm in COVID-19 without immunosuppression. In a prior clinical trial in psoriasis, EDP1815 was well tolerated with no overall difference in safety findings from placebo. EDP1815’s mechanism of action may make it suitable for early intervention in COVID-19 patients who have not yet been shown to benefit from anti-inflammatory therapy. If EDP1815 is successfully developed and approved, it can be manufactured at scale and at an affordable cost, which could potentially address a large patient population,” Bodmer said in a statement.

If EDP1815 demonstrates efficacy in COVID-19 patients in the TACTIC-E study, Evelo said it plans to work with regulatory agencies to determine if the data support registration. Interim data from the TACTIC-E study is expected in the fourth quarter of 2020.

Myovant announced topline results from SPIRIT 1, the second Phase III trial of once-daily relugolix combination therapy in women with pain linked with endometriosis. The drug combination met its co-primary efficacy endpoints as well as all seven key secondary endpoints.

Endometriosis is an inflammatory disease where tissue similar to the uterine lining is found outside the uterine cavity. It is estrogen dependent and results in chronic inflammation and can cause scarring and adhesions. Symptoms include painful periods and chronic pelvic pain, painful ovulation, pain during or after sexual intercourse, heavy bleeding, fatigue, and infertility.

Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist. It decreases production of ovarian estradiol, a hormone that can stimulate the growth of uterine fibroids and endometriosis, as well as testicular testosterone. The combination therapy is 40 mg of relugolix plus 1.0 mg estradiol and 0.5 mg norethindrone acetate.

“An estimated six million women in the U.S. suffer from symptoms and effects of endometriosis, which can include severe pain and significant impact on well-being, as seen by women who participated in the SPIRIT studies,” said Eric L. Brown, a practicing obstetrician-gynecologist and coordinating investigator in the SPIRIT program.

Brown added, “Women need and deserve treatment options beyond surgery, and these data indicate relugolix combination therapy has the potential to substantially reduce pain while improving function and activities of daily living and decreasing the proportion of women on opioids, all with a well-tolerated safety profile.”

As did the previously announced SPIRIT 2 study, the relugolix combination in SPIRIT 1 hit both co-primary endpoints of clinically meaningful pain reductions for 74.5% of women with menstrual pain and 58.5% of women with non-menstrual pelvic pain, compared to 26.9% and 39.6% of women in the placebo group, respectively. On average, the relugolix combination therapy showed a 73.3% decrease on the 11-point (1 to 10) Numerical Rating Scale for dysmenorrhea from 7.3 (severe pain) to 1.8 (mild pain).

All seven key secondary endpoints at Week 24 hit the mark as well, including changes in mean dysmenorrhea and overall pelvic pain, impact of pain on daily activities, great proportions of women not using pain medications, changes in mean non-menstrual pelvic pain, greater proportion of women not using opioids, and changes in painful intercourse.

Myovant also announced that its New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for men with advanced prostate cancer was accepted by the U.S. Food and Drug Administration (FDA) for Priority Review.

The submission was based on efficacy and safety data from the Phase III HERO trial which was published in the New England Journal of Medicine at the end of May. The data was also presented at the American Society of Clinical Oncology Virtual Scientific Program. The data expanded on earlier data from the HERO trial, showing the superiority of relugolix to leuprolide acetate across multiple endpoints. Relugolix was also associated with a lower risk of major adverse cardiovascular events compared to leuprolide acetate.

“Cardiovascular disease is the leading cause of death in men with prostate cancer,” said Neal Shore, medical director of the Carolina Urologic Research Center, HERO program steering committee member, presenter of the ASCO data, and lead author on the NEJM paper. “An oral therapeutic option with strong efficacy that also reduces cardiovascular risk compared to that of conventional GnRH agonist therapy would be a critical achievement for men with advanced prostate cancer.”

Juan Camilo Arjona Ferreira, chief medical officer of Myovant, noted today, “Relugolix has now achieved positive results in five Phase III studies across three indications, demonstrating its potential to benefit women with pain from endometriosis and women with heavy menstrual bleeding from uterine fibroids as well as men with advanced prostate cancer. We look forward to sharing the one-year data from the SPIRIT extension study and submitting a New Drug Application to the FDA for this one dose, one pill, once a day potential treatment for women with endometriosis, which would be our third NDA submission in short succession.”

A committee led by cabinet secretary Rajiv Gauba has also decided to set up a nodal coordination committee to ensure expeditious disposal of all applications with the decision binding on all regulators. “The proposal was cleared by the committee in the first week of June,” a top government official told ET.

New Delhi: The government has designated the Central Drugs Standard Control Organisation (CDSCO) as the first point of registration for clinical trials of all drugs and vaccines, a move expected to cut the approval time to three months from 12 months.

A committee led by cabinet secretary Rajiv Gauba has also decided to set up a nodal coordination committee to ensure expeditious disposal of all applications with the decision binding on all regulators.

“The proposal was cleared by the committee in the first week of June,” a top government official told ET.

The proposal to hasten clearances in the short-term was mooted by the Niti Aayog in the wake of the Covid-19 pandemic.

“Regulatory cholesterol, which was severely impacting innovation in pharma and biotech sector, has now been addressed,” NITI Aayog CEO Amitabh Kant said. “By streamlining regulatory pathways in CDSCO and ICMR, we have brought all institutions and regulators together through a series of meetings by cabinet secretary and in NITI Aayog.”

The official quoted earlier said the government will soon come out with medium and long-term measures to expedite the approval process as it looks to attract foreign capital and boost local pharma.

Single-window
The cabinet secretary-led panel has suggested multiple regulators and authorities dealing with approvals to revisit their approval process. The idea, the official said, is to eliminate unnecessary processes.

Following this decision, all clinical trial applications will be first registered with CDSCO, which will issue a common identification number. This number will be used to track the application at each stage.

Each application will be scrutinised and sent to the respective committees for approval. The nodal coordination committee, under the health secretary and comprising secretaries of all committees and ministries concerned, will meet once in 15 days during the pandemic and once in a month after that to clear any proposals stuck at different levels.