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GOTHENBURG, Sweden, Dec. 8, 2020 /PRNewswire/ — Vicore Pharma Holding AB (publ), a pharmaceutical company dedicated to developing innovative medicines for severe lung disorders, today announces positive top line data from the ATTRACT COVID-19 trial with C21 (VP01). A webcast presentation will be held today at 15:00 CET (9 am EST).

The ATTRACT study was a randomized, double-blind and placebo-controlled trial investigating the efficacy of oral C21 compared with placebo in 106 hospitalized COVID-19 patients with signs of an acute respiratory infection but not requiring mechanical ventilation. Many of these patients go on to experience respiratory distress, as manifested by the need for supplemental oxygen, often leading to acute respiratory failure if the disease progresses. The need for oxygen treatment reflects progress of the infection to the lower airways where gas exchange occurs.

Topline results:

• C21 reduced the risk of needing oxygen at the end of treatment by 40 %, an effect that was statistically significant (p=0.057) at the 10% level as predefined in the Statistical Analysis Plan.
• There was a clear trend for C21 reducing number of patients needing mechanical ventilation, with four patients in the placebo group compared to one in the C21 group.
• There was also a trend for C21 reducing mortality, with three deaths in the placebo group compared with one in the C21 group.
• C21 was well tolerated in this population of severely sick patients.

Vicore Pharma will continue to analyze the data from the study and more information will be presented in due course.

“Given the nature and scale of this study, we are surprised to see such a clear and significant clinical benefit for C21”, says Carl-Johan Dalsgaard, CEO of Vicore Pharma, “and given the severity and duration of the pandemic, an oral C21 formulation with an excellent safety and tolerability profile could become an important and convenient early treatment of COVID-19, fulfilling a huge medical need. In addition, these results bode well for our ongoing study in idiopathic pulmonary fibrosis (IPF) as well as for future studies in larger indications where activation of AT2R may have a role to play”.

Dr. Reema Kashiva, Principal Investigator at Noble Hospital and Research Centre, Pune, India, said: “Given the severity of COVID-19, it is encouraging to see promising clinically meaningful results such as the impact of C21 on oxygen use, suggesting potential utility of this medicine on shifting the treatment paradigm of this aggressive disease.” 

Webcast presentation           
Vicore Pharma will host a webcast to present more about the outcome of the study at 15.00 CET (9 am EST) today that can be accessed via the link: https://financialhearings.com/event/13550

Pune-based Gennova Biopharmaceuticals Ltd has got conditional permission for phases 1 and 2 human clinical trial of its COVID-19 vaccine.

The Drugs Controller General of India (DCGI) on Wednesday granted conditional permission for phases 1 and 2 human clinical trial of the COVID-19 vaccine candidate developed by the Pune-based Gennova Biopharmaceuticals Ltd in collaboration with HDT, USA, officials said.

The recommendations of the Subject Expert Committee (SEC) on COVID-19, which deliberated upon the proposal submitted by the firm for grant of permission to conduct phases 1 and 2 clinical trials along with animal toxicity study data, has been approved by DCGI.

“After detailed deliberation, the committee recommended for grant of permission to conduct phase 1 and 2 clinical trial subject to the condition that the interim results of phase 1 study shall be submitted to the committee before proceeding to the next phase,” the SEC recommendations stated.

The Department of Biotechnology had earlier said it has provided seed funding for the development of Gennova”s novel self-amplifying mRNA-based vaccine candidate for COVID-19.

In collaboration with HDT Biotech Corporation, USA, Gennova has developed an mRNA vaccine candidate (HGCO19), with demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models, it had said.

“DBT-BIRAC has facilitated the establishment of the first-of-its-kind mRNA-based vaccine manufacturing platform in India. DBT has provided seed funding for the development of Gennova’s novel self-amplifying mRNA-based vaccine candidate for COVID-19,” the DBT had said in a statement earlier.

As the United Kingdom began administering people with the Pfizer-BioNTech vaccine, four people who got Pfizer’s coronavirus vaccine in the firm’s trial developed Bell’s palsy, a form of temporary facial paralysis, according to US regulators’ report on the shot.

Food and Drug Administration (FDA) regulators said there wasn’t any clear way that the vaccine caused Bell’s palsy, but warned that doctors should watch for the alarming side effect and Pfizer should continue to keep tab on how many people it strikes.

Bell’s palsy is a condition that causes temporary weakness or paralysis of the facial muscles. It can usually occur when a nerve that controls the muscles becomes inflamed, swollen or compressed.

Meanwhile, Pfizer chief executive Albert Bourla said the company did not “cut any corners” while rolling out the vaccines.

Clinical-stage immunotherapy company Enlivex Therapeutics has reported positive interim data from the Phase II clinical trial of Allocetra in severe and critical Covid-19 patients.

Clinical-stage immunotherapy company Enlivex Therapeutics has reported positive interim data from the Phase II clinical trial of Allocetra in severe and critical Covid-19 patients.

The multi-centre, investigator-initiated trial is evaluating Allocetra’s safety, tolerability, cytokine profile and efficacy parameters in combination with standard of care treatment.

It will enrol about 24 patients with severe or critical Covid-19, as defined by the US National Institute of Health (NIH).

According to data from the ongoing Phase II trial and previously reported investigator-initiated Phase Ib study, all (seven) patients treated until 26 November had a complete recovery from their severe/critical condition.

Together with previously treated patients from Phase Ib study, all (12) patients who received Allocetra had a complete recovery and were discharged from the hospital after an average of 5.5 days.

In the Phase II study, an eighth critically ill patient enrolled on 27 November showed clinical improvement on receiving the treatment and is hospitalised with moderate/severe condition.

Data from the Phase Ib study showed that an average of nine days to hospital discharge was observed following the treatment in critical patients.

Clinical-stage biotherapeutics company PureTech Health has initiated the global, Phase II trial of LYT-100 (deupirfenidone) in Long COVID respiratory complications and related Sequelae.

Clinical-stage biotherapeutics company PureTech Health has initiated the global, Phase II trial of LYT-100 (deupirfenidone) in Long COVID respiratory complications and related Sequelae.

A condition where Covid-19 survivors are at risk of persistent complications is known as Long COVID or Long Haul COVID.

A deuterated analogue of pirfenidone, LYT-100 is an oral small molecule wholly owned by PureTech.

The Phase II trial began after the completion of a Phase I multiple ascending dose and food effect study of LYT-100 in healthy volunteers.

The latest global, randomised, double-blind, placebo-controlled Phase II trial will analyse the efficacy, safety and tolerability of LYT-100 in adults with post-acute Covid-19 respiratory complications.

The trial’s primary endpoint will be the six-minute walk test distance and secondary endpoints include pharmacokinetics, inflammatory biomarkers, imaging and patient-reported outcomes.

PureTech Long COVID Phase II trial principal investigator Toby Maher said: “Covid-19 is a global public health crisis with severe and long-lasting effects.

“Patients around the world have reported persistent suffering, including serious respiratory complications that can last for months after the acute infection resolves, and, even with vaccines, there is great a need for treatment options for Long COVID.

“The anti-fibrotic and anti-inflammatory properties of LYT-100 hold potential for treating a range of respiratory conditions, including the long-lasting health burden associated with post-acute Covid-19.”

Results from the study initiated in the US and Europe are expected in the second half of next year.

In May, PureTech announced plans to conduct a trial to evaluate LYT-100 to treat Long COVID.

Clinical-stage biopharma firm Senhwa Biosciences has enrolled the first patient in a Phase II investigator-initiated trial (IIT) of its anti-SARS-CoV-2 investigational drug, Silmitasertib, for treating Covid-19.

Clinical-stage biopharma firm Senhwa Biosciences has enrolled the first patient in a Phase II investigator-initiated trial (IIT) of its anti-SARS-CoV-2 investigational drug, Silmitasertib, for treating Covid-19.

The patient with moderate Covid-19 was enrolled at the Center for Advanced Research and Education (CARE) in Gainesville, Georgia.

A small-molecule oral drug, Silmitasertib targets the host protein kinase casein kinase 2 (CK2) pathway, where virus mutations might not affect its anti-viral and anti-inflammatory efficacy.

In August, the CK2-inhibitor received an eIND from the US Food and Drug Administration (FDA) to treat a patient with severe Covid-19.

Principal investigator of the trial Dr Chris Recknor said: “Silmitasertib’s mechanism of action by CK2 inhibition is a unique pathway to target SARS-CoV-2 infection which has promise to combat Covid-19.”

The single-centre, open-label, randomised-controlled interventional prospective study will have 20 patients with moderate Covid-19 and half of them will be given Silmitasertib for 14 days.

Evaluating the safety and tolerability of the drug, recovery time of the patient and possible clinical benefits of treatment with Silmitasertib are the trial’s objectives.

Senhwa Biosciences chief medical officer Dr John Soong said: “We are encouraged by the quick recovery of the first hospitalised patient with severe Covid-19 who received Silmitasertib under an emergency IND.

“We also believe Silmitasertib has the potential to be an effective outpatient treatment for patients with moderate Covid-19.”

Apart from this, a Phase II IIT led by Dr Marilyn Glassberg Csete at Banner – University Medical Center Phoenix is set to start as FDA has given nod.

The trial plans to enrol around 40 hospitalised patients with severe Covid-19.

Ampio Pharmaceuticals has announced that its AP-014 Phase I clinical inhaled Ampion study is proceeding to full open enrolment of Covid-19 patients with respiratory distress.

Ampio Pharmaceuticals has announced that its AP-014 Phase I clinical inhaled Ampion study is proceeding to full open enrolment of Covid-19 patients with respiratory distress.

The latest development follows clearance from the Safety Monitoring Committee (SMC), which found Ampion to be safe and well-tolerated after reviewing results from the first three treatment groups.

The trial can now fast track the completion of the remaining 34 patients’ enrolment at the speed of recruitment.

“The enrolment of patients will proceed quickly, perhaps doubling the number of patients enrolled by the end of today.”

This will be done using a hand-held nebulizer for Covid-19 patients early in the disease and non-invasive ventilation or face mask and mechanical ventilation or intubation in severe cases.

This trial will have 40 patients in the US who will randomly receive inhaled Ampion versus Standard of Care (SOC). Each patient will be given 8ml doses of Ampion four times a day for five days.

The trial’s primary end point is safety of the drug and other measurements indicative of efficacy will form the secondary endpoints.

As inhalation is a novel method for the administration of Ampion, cleared for clinical use by the FDA, the SMC analysed each of the first three patient groups receiving inhaled Ampion for three more days.

The SMC observed no safety concerns related to inhaled Ampion in any of these groups and approved to complete the enrolment.

In September, Ampio Pharmaceuticals completed enrolment for its Phase I clinical trial of Ampion intravenous treatment for Covid-19 patients who need supplemental oxygen.

University of Minnesota Medical School and UnitedHealth Group researchers found that metformin was associated with significantly reduced COVID-19 death risks in women in one of the world’s largest observational studies of COVID-19 patients.

Metformin is an established, generic medication for managing blood sugar levels in patients with type 2 diabetes. It also reduces inflammation proteins like TNF-alpha that appear to make COVID-19 worse.

The study, published in The Lancet Healthy Longevity, is a retrospective cohort analysis based on de-identified patient data from UnitedHealth Group. The team analyzed about 6,000 individuals with type 2 diabetes or obesity who were hospitalized with COVID-19 and assessed whether or not metformin use was associated with decreased mortality.

A global phishing campaign has been targeting organizations associated with the distribution of COVID-19 vaccines since September 2020, IBM security researchers say.

In a blog post, analysts Claire Zaboeva and Melissa Frydrych of IBM X-Force IRIS announced that the phishing campaign spans six regions: Germany, Italy, South Korea, Czech Republic, greater Europe, and Taiwan.

The campaign appears to be focused on the “cold chain,” the segment of the vaccine supply chain that keeps doses cold during their storage and transportation. Some vaccines need to stay at extremely low temperatures in order to remain potent. Pfizer, for example, recommends that their COVID-19 vaccine be stored at negative 70 degrees Celsius (colder than winter in Antarctica). That poses a logistical challenge for the pharmaceutical company, which will need to transport millions upon millions of doses around the world at that temperature.

The attacks focused on groups associated with Gavi, an international organization that promotes vaccine access and distribution. Specifically, it targeted organizations related to their Cold Chain Equipment Optimization Platform (CCEOP), which aims to distribute and improve technology that can keep vaccines at very cold temperatures. These included the European Commission’s Directorate-General for Taxation and Customs Union, as well as “organizations within the energy, manufacturing, website creation and software and internet security solutions sectors.”

Per the blog post, the people behind the phishing operation sent emails to the organizations’ executives claiming to be an executive from CCEOP supplier Haier Biomedical. The emails, which purported to request quotations related to CCEOP, contained HTML attachments which asked for the opener’s credentials, which the actor could store and use to gain unauthorized access down the line.

“We assess that the purpose of this COVID-19 phishing campaign may have been to harvest credentials, possibly to gain future unauthorized access to corporate networks and sensitive information relating to the COVID-19 vaccine distribution,” reads the blog post.

It’s not yet clear who’s behind this campaign, but the researchers suspect a nation-state actor rather than a private individual or group. “Without a clear path to a cash-out, cyber criminals are unlikely to devote the time and resources required to execute such a calculated operation with so many interlinked and globally distributed targets,” the blog post reads. “Advanced insight into the purchase and movement of a vaccine that can impact life and the global economy is likely a high-value and high-priority nation-state target.”

IBM recommends that companies involved in COVID-19 vaccine storage and transport “be vigilant and remain on high alert during this time.” The Cybersecurity and Infrastructure Security Agency (CISA) has issued an alert encouraging the organizations to review IBM’s report.

COVID-19 vaccine research and development has been a target of multiple cyberattacks this year. The US government accused China of funding and operating hacking cells to steal vaccine research from the US and its allies in May, and charged two Chinese hackerswith stealing data from firms working on COVID-19 treatments and vaccines in July. US, UK, and Canadian authorities denounced attacks from a group associated with Russian intelligence services on organizations involved in vaccine development this summer. In November, Microsoft detected cyberattacks from nation-state actors in Russia and North Korea on companies with COVID-19 vaccines in various stages of clinical trials.

Multiple companies have submitted COVID-19 vaccines for review to the Food and Drug Administration, including Pfizer / BioNTech and Moderna. The FDA’s vaccine advisory community will review the applications in mid-December; if the vaccines are authorized, distribution will begin shortly after. Moderna expects to have up to 20 million doses of its vaccine by the end of 2020, while Pfizer could provide up to 25 million.

EMA’s safety committee (PRAC) has recommended updating the product information for all chloroquine or hydroxychloroquine-containing medicines following a review of all available data that confirmed a link between the use of these medicines and the risk of psychiatric disorders and suicidal behaviour.

The review was initiated in May 2020 after EMA had been informed by the Spanish Medicines Agency AEMPS of six cases of psychiatric disorders in patients with COVID-19 who were given higher than authorised doses of hydroxychloroquine. Chloroquine and hydroxychloroquine are authorised in the EU for the treatment of certain autoimmune diseases, such as rheumatoid arthritis and lupus, as well as for prophylaxis and treatment of malaria. They are not authorised for the treatment of COVID-19, but both medicines have been used as off-label treatment in patients with the disease. However, chloroquine and hydroxychloroquine have not shownany beneficial effects in treating COVID-19 in large randomised clinical trials.

In view of their use during the COVID-19 pandemic, EMA had reminded healthcare professionals of the risks of these medicines in April and in May 2020. It is already known that chloroquine and hydroxychloroquine, even used in approved doses for authorised indications, can cause a wide spectrum of psychiatric disorders. Psychotic disorders and suicidal behaviour are listed in the product information of some chloroquine or hydroxychloroquine-containing medicines as rare side effects or side effects occurring at an unknown frequency.

The review confirmed that psychiatric disorders have occurred and may sometimes be serious, both in patients with and without prior mental health problems. Based on the available data, the review showed that, for hydroxychloroquine, the side effects may occur in the first month after the start of treatment. For chloroquine, there was not sufficient data to establish a clear timeframe.

The PRAC recommends updating the product information for these medicines to provide better information to healthcare professionals and patients on the risk of suicidal behaviour and psychiatric disorders.

Patients using chloroquine or hydroxychloroquine medicines who experience mental health problems (e.g. irrational thoughts, anxiety, hallucinations, feeling confused or feeling depressed, including thoughts of self-harm or suicide), or others around them who notice these side effects, should contact  a doctor straight away.