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Sidekick Health is already working with pharma heavyweights Pfizer and Bayer on gamified apps that can be paired with drug therapies to improve patient outcomes – and says it is poised to announce three more in the coming months.

The Iceland-based digital health company – which has just raised $55 million in second-round funding – has been working with Bayer on an app/medicine combination for patients with peripheral artery disease since 2019, and in the following year cut a deal with Pfizer to take a similar approach to five inflammatory disease.

Sidekick also works with health insurance company Anthem, providing digital-based care programmes for members dealing with COVID-19, Crohn’s disease, and other chronic conditions.

Dr Tryggvi Thorgeirsson, Sidekick’s chief executive, told pharmaphorum that one of the new partnerships will be a collaboration “to support patients with breast cancer, where we will augment pharmacotherapy and help patients manage side effects.”

“The major challenge facing the world’s healthcare systems is how to support and treat people who are dealing with two or more chronic conditions,” he said.

“The cornerstone of Sidekick’s approach is our multi-chronic digital therapeutics platform, and this funding will allow us to scale even faster the production of a new generation of clinical treatments across all major chronic diseases.”

Along with the new partnerships, Sidekick is also planning to grow dramatically over the next 12 months, using the cash injection to double its headcount from 120 to 240 staff.

It also plans to expand further into the US market, where legislative trends and healthcare spending have made it important for Sidekick to ramp up its US-based operations, according to Thorgeirsson.

One key example is the recently-introduced Access to Prescription Digital Therapeutics Act of 2022, which aims to officially define prescription digital therapeutics (PDTx) at the federal level and establish new Medicare and Medicaid benefit categories for the category. Similar initiatives are underway in German and France, he said.

The company has already made a series of US-based hires, appointing three healthcare industry veterans to its C-suite in recent months, all with history at UnitedHealth Group.

Steven Auerbach was named executive chairman last year, with Pamela Stahl taking the role of chief commercial officer and North American president and Mitchell Mudra joining as chief operating officer earlier this year.

“We have also established a dedicated pharma business development and growth team, led by Philips veteran Mark Slaughter, infused with seasoned biotech and medtech dealmakers,” said  Thorgeirsson.

“These new leaders bring a level of talent and expertise to our executive team that will help us accelerate our growth.”

The Series B was led by London-based venture capital firm Novator Ventures, with participation from Wellington Partners, Asabys Partners, Frumtak Ventures, and an as-yet undisclosed US investor.

Novator’s general partner and founder Birgir Mar Ragnarsson has joined Sidekick’s board of directors following the financing.

“By 2026, it is estimated a billion people will be served by some form of DTx annually,” said Thorgeirsson.

“Sidekick, along with our investors, clinical partners, and our patients, firmly believe that we are well positioned as the DTx portfolio and clinical-technology platform of choice for leading healthcare companies.”

The company said it views oncology and increased personalisation as current high impact areas for the PDTx category.

The US FDA has authorised a new test that can detect amyloid plaques in early-stage Alzheimer’s disease without the use of PET scans, which expose patients to radiation.

Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio (1-42/1-40) test has been cleared for use in adult patients aged 55 years and older who have cognitive impairment and are being evaluated for Alzheimer’s and other causes of cognitive decline.

The in vitro diagnostic has been awarded a breakthrough device designation, a status reserved for products that can overcome patient care challenges that accelerated its path through the review process. It has already been approved for use in the EU.

Jeff Shuren, director of the FDA’s Centre for Devices and Radiological health, said the new test could do away with the need for “time-consuming and expensive” PET scans, which carry a radiation risk, and is “great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status…to help determine if a patient’s cognitive impairment is due to Alzheimer’s,” he added.

PET scanning can also be difficult to access for some patients, and as a result, many are not diagnosed until their disease is well advanced, with few available treatment options.

The test measures the ratio of the proteins β-amyloid 1-42 and β-amyloid 1-40 in the cerebral spinal fluid (CSF), which according to Fujirebio has the potential to be used in clinical settings and within clinical trials to predict brain β-amyloid burden.

“The lack of effective and accessible clinical tools for patients who could be on the pathway to develop Alzheimer’s disease contributes to its late diagnosis and inadequate treatment,” commented Monte Wiltse, Fujirebio Diagnostics’ chief executive.

Along with earlier diagnosis and treatment, the new test “will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of Alzheimer’s disease increases with a rapidly ageing population globally,” he added.

The approval comes as Biogen has abandoned efforts to commercialise its Alzheimer’s therapy Aduhelm (aducanumab), the only drug approved for the disease that targets the amyloid, after restrictions were placed on its use.

The move leaves patients with few treatment options, centred around drugs like cholinesterase inhibitors that are used to boost neurotransmitter levels in the brain but have limited efficacy.

Biogen and partner Eisai are still working on a follow-up amyloid drug, lecanemab, and other companies including Roche and Eli Lilly also have candidates in late-stage development.

Lilly is working in parallel on a diagnostic for Alzheimer’s that uses a simple blood test, while other groups are looking at alternative ways to diagnose the disease early, such as artificial intelligence-based imaging technology and cognitive testing tools.

Researchers at the University of Illinois at Chicago have uncovered the possibility of utilizing gene editing to reverse a cause of anxiety and alcohol use disorder (AUD). The study, published by Science Advances, provides a new approach to a disorder that affects 15 million U.S. adults.

The gene-editing treatment would be effective in patients who began abusing alcohol at an early age, which impairs normal epigenetic and transcription changes associated with brain maturity. This disruption in development is linked to AUD, anxiety and various other psychiatric disorders that can persist through adulthood.

One of the changes that are decreased with early alcohol consumption is the activity-regulated cytoskeleton-associated (Arc) gene expression, in the brain’s amygdala. The arc protein is critical for coordinating synaptic plasticity, such as long-term memory. Arc activity also regulates non-selective histone deacetylase (HDAC), which is important for cognitive function.

Using CRISPR-dCas9, the arc gene activity was able to be evaluated and upregulated to increase histone acetylation. The Cas9 technology was chosen for the ability to easily change specific epigenetic marks, without cutting genetic material or introducing opportunities for error.

With increased histone acetylation of the arc gene, AUD and anxiety decreased in rat experiments.

Subhash Pandey, a senior author of the study, Joseph A. Flaherty Endowed Professor of Psychiatry and director of the Center for Alcohol Research in Epigenetics at UIC, commented on the findings.

“Early binge drinking can have long-lasting and significant effects on the brain, and the results of this study offer evidence that gene editing is a potential antidote to these effects, offering a kind of factory reset for the brain, if you will.” 

Historically, treating addictions that began early in life is very difficult. This difficulty was echoed by Anthony Tennyson, co-founder of Awakn Life Sciences, in a previous interview for BioSpace. 

“There are few effective treatments for addiction that address its root causes,” Tennyson said. 

Tennyson has a different approach to treating addictions. Awakn combines psychotherapy and psychedelics to treat addiction at its core, instead of just treating the symptoms. For alcohol use disorder, the company uses MDMA (methylenedioxymethamphetamine).

For the scientists at UIL, the method was different, but the end goal was the same. The study included the use of anesthetized adult rats and dCas9 modified lentiviruses. The viruses were modified using dCas9 to increase arc gene activity. The virus was infused directly into the rat brains, and behavior was observed after one week of recovery.

Behavioral tests included an ethanol two-bottle choice drinking paradigm, a sucrose 2BC drinking paradigm, an EPM exploration test and a light-dark box exploration test. These tests show how the rats respond to anxiety-inducing stimuli and drinking preferences when given options. After humane sacrifice, the rats’ amygdala were examined using a ChIP assay to examine genome proteome linkages, real-time PCR, a 3C real-time PCR, and immunofluorescent staining.

The research is funded through grants from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Department of Veterans Affairs Senior Research Career Scientist Award. The funds were given to support the exploration of additional treatment options for those with AUD or anxiety, as current options are limited to therapy and Alcoholics Anonymous support groups, along with medications that modulate alcoholic dependence or anxiety symptoms. The research conducted by the University of Illinois Chicago is a treatment that would reverse the effects stemming from early alcohol abuse.

The solution enables biopharmaceutical and CROs to detect risks linked to trials and sites using improved statistical algorithms.

IT services, consulting and business solutions organisation Tata Consultancy Services (TCS) has introduced a risk-based monitoring solution for clinical trials. 

The swift and intuitive solution is part of the TCS ADD suite and enables intelligent decision making, enhances compliance and boosts the efficacy of the study.

Biopharmaceutical and contract research organisations (CROs) can use the solution to detect risks linked to trials and sites using improved statistical algorithms, as well as make intelligent data-driven decisions. 

Furthermore, the data science-steered solution accurately forecasts outcomes related to site workload and risks, allowing stakeholders to plan proactive monitoring approaches.

The solution comprises intelligent risk management, which enables automated triggers for outliers using innovative visualisations and analytics.

It also has predictive analytics based on artificial intelligence (AI) / machine learning (ML) and more than 40 operational metrics across the trial, subject, site, data management and budget management segments.

In addition, the solution’s one-click communication module offers a combined and organised list of pending tasks, as well as system-created intelligent actions across all source systems.

The system offers insights into missing data, boosts data quality and consistency, as well as allows early detection of trends and outliers. 

By leveraging this solution, sponsors and CROs are expected to increase efficiency by up to 30% in site monitoring. 

TCS Life Sciences Healthcare and Public Services business group head Debashis Ghosh said: “With Covid-19 critically impacting site visits, life sciences industries realised the value of remote risk-based monitoring solutions that empower sponsors to monitor trials centrally, assess the risks and track corrective actions to enhance study quality. 

“With our deep domain knowledge of the life sciences industry, we are continually expanding the capabilities of our modern and open TCS ADD platform to include data science, artificial intelligence and machine learning led clinical operational analytics solutions that transform the drug development value chain, deliver greater value for our customers and achieve faster compliance.”

Prior to the acquisition of CureClick, Thread acquired Modus Outcomes and inVibe.

Decentralised clinical trial (DCT) technology and consulting service provider Thread has acquired US-based CureClick to improve the pathway from clinical trial awareness to access.

Established in 2013, CureClick provides the world’s first crowdsourcing platform built to expedite clinical research awareness and participation. 

Its existing community-steered network comprises over 6,500 ambassadors and patient advocates representing more than 75 disease states with a global reach exceeding one million patients. 

With the acquisition, CureClick founder Fabio Gratton will take over as Thread’s chief experience officer.

Furthermore, CureClick’s technology and a wide network of community leaders will become part of the global patient enrolment offering of Thread. 

This new scaled marketplace will function as Thread’s DCT platform feature, further automating and simplifying the pathway from trial education to enrolment for DCTs worldwide.

The latest deal comes after Thread’s recent acquisition of Modus Outcomes and inVibe.

Thread CEO John Reites said: “One of the advantages of decentralisation is engaging patients from broader geographic areas and more diverse backgrounds into clinical research so that trials better represent real-world populations.

“CureClick helps our customers make their clinical trials more accessible and inclusive while better supporting our existing base of premier recruitment-focused partners who can leverage a new marketplace for their services.”

Thread aids biopharma and contract research organisations in decentralising clinical research and facilitating electronic clinical outcome assessments for subjects, sites, caregivers and home health specialists. 

In February this year, Thread and life sciences commercial services company Eversana partnered to provide a new decentralised registry and real-world data (RWD)-driven solution for pharmaceutical firms.

The trial will analyse SNIPR001’s safety and tolerability and its effect on decreasing the colonisation of E. coli in the gut.

SNIPR BIOME has initiated dosing of the first subjects with SNIPR001, an oral clustered regularly interspaced short palindromic repeats (CRISPR)-based therapy in a Phase I clinical trial.

Being developed in partnership with US-based non-profit organisation CARB-X, the investigational CRISPR therapy is intended to selectively act on and eliminate E. coli in the gut. 

This averts their translocation to the bloodstream in an increased risk population of patients with haematological cancer who are at risk for neutropenia.

The precision technique could potentially change the way E. coliinfections are avoided and treated, particularly in the cancer ward. 

Currently, no approved treatments for prophylactic therapy exist in this setting.

The trial will analyse the safety and tolerability of SNIPR001 in healthy subjects, as well as assess SNIPR001’s effect on reducing the colonisation of E. coli in the gut. 

Nearly 36 healthy participants will be part of the trial to evaluate multiple ascending dosing of the oral therapy.

Earlier, the US Food and Drug Administration granted Fast-Track designation to SNIPR001.

“We are in parallel pursuing our pipeline of CRISPR-medicines of exciting targets within oncology, immunology and cardio-metabolism, and have an ambition of selecting the next molecule from our pipeline to move into IND enabling studies also by the end of this year.”

The Denmark-based CRISPR and microbiome gene therapy biotechnology company focuses on discovering and developing CRISPR/Cas-based therapies. 

To address key unmet medical needs, the company uses its CRISPR technologies to act on microbial pathogens and remodel the microbiome.

The new name and branding come after a three-year series of strategic acquisitions.

International biopharmaceutical services provide, CATO SMS has rebranded and became Allucent to aid in bringing advanced therapies to light.

The latest move is aimed at underscoring the company’s spotlight on meeting the specified requirements of small and mid-sized biotech firms.

The new name and branding come after a three-year series of strategic takeovers of Array Biostatistics, Nuventra and clinical research provider Pharm-Olam.

These acquisitions doubled the size of the company, boosted and extended its expertise and enlarged its reach globally.

With over three decades of experience, Allucent is now a unified organisation intended for backing small and mid-sized biotech firms in achieving breakthrough science.

Established to address this requirement, the company provides full-service clinical trial expertise, deep treatment capabilities, product development and consultation services.

Allucent chairman and CEO Mark Goldberg said: “In three short years, we’ve transformed our company to meet the unique needs of small and mid-sized biotechs. 

“Our new name, Allucent, puts the focus on the clients we exist to serve and aligns our people under our shared passion of helping to bring new therapies to light. 

“As we continue our growth journey, we’re committed to making sure we remain big enough to deliver but small enough to care.”

Allucent will leverage deep capabilities and a high-touch collaboration model to provide various services and therapeutic expertise for biotech firms including flexible clinical and regulatory solutions and a team of international consultants. 

It also has strong scientific and drug development capabilities, a worldwide workforce of over 1,200 staff and broader coverage geographically in more than 60 countries.

In March this year, CATO SMS was engaged as GeoVax Labs’ clinical research organisation partner to handle two Phase II trials of its Covid-19 vaccine candidate, GEO-CM04S1.

Five Chinese companies face potential delisting from Wall Street if they fail to comply with new audit orders from the U.S. Securities and Exchange Commission (SEC). The SEC said that Yum China, BeiGene, Zai Lab, HutchMed and ACM are all at risk if they do not give U.S. regulators access to their audit records.  

These five companies all recently filed their annual reports with the SEC, and they are the first Chinese companies to be identified as failing to comply. They could soon be followed by all Chinese companies on the SEC’s list, about 270 in total. These companies account for some $2.1 trillion in total market capitalization.  

Unfortunately, the lack of compliance could be out of these businesses’ control. Beijing has blocked Chinese companies from complying with these requirements by only allowing domestic firms access to audit paperwork. 

The audit orders follow the Holding Foreign Companies Accountable Act (HFCAA)passed in December of 2020. Essentially, the law mandates that the Public Company Accounting Oversight Board (PCAOB) must be able to inspect audits of foreign firms listed on US markets. It is specifically targeted to Chinese companies, and it permits the SEC to ban companies from trading and be delisted from U.S. exchanges if American regulators are not able to review company audits for three consecutive years. 

Of the five companies currently at risk, Yum China is one of the most profitable. It controls KFC, Taco Bell and Pizza Hut in China, and currently has a market capitalization of $18.8 billion. When the company’s potential delisting was announced on Thursday, Yum China’s stocks dropped 15%.  

In a US regulatory filing at the end of February, Yum China stated that its shares would be delisted in 2024 due to “factors outside of our control including the approval of Chinese authorities.” 

Yum China isn’t the only company whose stocks were affected; the announcement spurred a large sell-off of Chinese stocks traded in the U.S. On Thursday, ACM Research was down 27%, HutchMed fell 8% and Zai Lab dropped 19%.

Biotech giant BeiGene, which currently has a market worth of $22 billion, fell 12%. A little over 50% of BeiGene’s listed shares are traded in New York, and the other half are traded in Hong Kong and Shanghai. 

In a statement to BioSpace, BeiGene emphasized that the SEC’s announcement was an administrative step, and a company’s listing would be impacted only after the PCAOB is unable to inspect the auditor for three consecutive years.

“BeiGene is a global biotech company, with significant operations in the US. We are working to be compliant with the HFCAA and fully expect to maintain our listings on the NASDAQ, HKEX and the Shanghai Stock Exchange,” the company told BioSpace. “As we have previously disclosed, since the emergence of the HFCAA act, we have invested significant efforts to evaluate and design additional business processes and control changes and are committed to implementing a solution that satisfies stakeholders’ expectations ahead of the deadline.”

Microchip equipment maker ACM is optimistic about the filing, most likely due to the fact that its headquarters are based in California. Following Thursday’s announcement by the SEC, ACM Research said that it is “actively seeking a solution, communicating and working to meet the SEC requirements by the 2024 deadline” in a filing to the Shanghai Stock Exchange. 

The SEC’s announcement is just one of many setbacks for Chinese companies doing business in the U.S. In February, the U.S. Food and Drug Administration announced that it was slowing down the process of potentially approving dozens of new medications that had initially been developed for the Chinese market, stating that it did not believe the data accrued in those studies was strong enough to support regulatory approval in the U.S. In July of 2021, the SEC halted registrations of U.S. initial public offerings (IPOs) by Chinese companies, saying that it was waiting for the Chinese government to disclose to investors the risks to investment with the Chinese government interfering in the businesses. 

In a post on WeChat, China’s most popular messaging app, China’s Securities Regulatory Commission said that authorities in China are communicating with the U.S. Public Company Accounting Oversight Board and have made “positive progress.”

The SRC stated that it respects overseas regulators’ efforts to strengthen supervision over accounting companies to improve the quality of the financial information of listed companies, but firmly opposes the wrong practice of some forces politicizing securities regulation.

Pharma has a chance at redefining its relationship to the public, allowing for direct interaction with potential clinical trial participants via social media. But what’s the risk?

Need to Know:

• Social media can be a powerful tool to directly advertise ongoing clinical trials to target patients, but such an unregulated space increases the risk of companies being exposed to negative or untrue comments.
• While having an inhouse press team allows a pharma company to have a dedicated crew for its communication plans, it may not have the same level of networks and resources that an external PR team might have.

Due to the swift action of the pharmaceutical industry to develop vaccines and therapeutics for Covid-19, its reputation among the public reached all time high favourable reviews. Public confidence towards the sector last year was at 62%, double to what it was before the pandemic, notes Rob Jekielek, managing director of market research company Harris Poll.

While the pharma industry’s score has since dropped by 15 points to 47% as the world focuses on other global events, there’s still opportunity to mine this reputational rise to benefit clinical trial progress.

While there was reluctance to enrol into clinical trials, the public now understand the importance of participation, explains Ignacio Guerrero-Ros, PhD, account supervisor at healthcare public relations firm Russo Partners. Indeed, due to the pandemic, the industry has a once-in-generation opportunity to redefine its relationship with the public, adds Shahar Silbershatz, CEO of corporate reputation management Group Caliber.

Which begs the question: what can the clinical trial industry do to capitalise on the public’s confidence, as well as maintaining it at a relatively buoyant level? We look at the perks and risks at engaging with the public via social media specifically for recruitment, and the pros and cons of managing a company’s own PR needs inhouse rather than outsourcing them.

Social media and clinical trials: a double-edged sword

Social media is a highly targeted method of reaching audiences which can help accelerate the search in the right subpopulations, says Deborah Cockerill, managing partner at healthcare public relations firm Sciad Communications. Social media is a valuable tool to build up company visibility to specific patients, and even for patients to find companies running clinical trials they are after, notes Neil Hunter, communications director at healthcare public relations firm Image Box Communications.

While using social media to advertise an ongoing clinical trial may be straightforward, the posts being flooded by negative or untrue comments is a real risk. Social media is an unprotected and unregulated platform, Hunter explains.

And due to the fast nature of social media, negative comments can take a life of their own while the company is still trying to decide how to address such comments, Hunter adds. Pharma companies, particularly large ones, can have a delay to their public response due to many layers of internal approvals, he explains.

Silbershatz offers a third view, in that negative social media storms are a distraction, as it does not necessarily impact stakeholders that are relevant to the company. Instead, pharma companies should concentrate on communicating information to their stakeholder universe, he adds.

But clinical development information that is usually geared for stakeholders only leaves the wider public forgotten, Hunter notes. Pharma companies should share details to the wider public clearly, he says, adding there is the need for media literacy for the public.

Nevertheless, the best solution to combat negative social media issues is to avoid such situations in the first place. It is important to make sure messaging is fine-tuned and culturally appropriate, especially when reaching out to communities that are traditionally underrepresented in research, says Reena Patel, independent content specialist at Echo Public Relations. Customising social media messaging can also prevent from reaching unwanted audiences who might reacted negatively, she notes.

Pros and cons of outsourcing comms

Pharma companies can manage their public profile internally or by outsourcing their needs to specialist firms. Alongside the growth of the pharma industry, PR businesses catering to pharma also grew, Guerrero-Ros says. Small-to-medium pharma companies may not have enough resources to have in-house communications expert, which leads to outsourcing. “We [PR firms] are facilitators with a megaphone to help get the message out there,” Cockerill says.

Internal and external PR teams have inherent components that can be at the same time both positive and negative, Hunter says. The value of an external PR firm is that it has pre-existing relationships with media contacts or other relevant stakeholders, as well as offering an objective perspective on the information a company wants to release, Guerrero-Ros notes.

Pharma companies often seek external help to improve investor perception. While PR firms can offer this service, pharma companies need to be reminded that it will still come down to them to deliver milestones promised to stakeholders, Guerrero-Ros notes. “We are very clear from the beginning that us as communicators have no power over their stock, but we can assure that an article on Wall Street Journalwill not necessarily increase it,” he adds.

Internal PR offers a targeted approach

However, external PR have the disadvantage of being a separate entity from the organisation. Internal PR teams have direct access to key and C-level employees, whereas an external agency might need some time to find the right person and arrange interviews, Hunter says. Additionally, an internal PR team can concentrate on a single company’s needs, compared with external PR firms that split their resources to cater to multiple clients, he notes.

The optimal blend is to have a small internal PR team working with an external agency, Hunter says. The internal team’s specialist knowledge of the company can be shared with the external team’s knowledge of stakeholders and the market, he adds. Both teams need to collaborate on collective strategies to present to the C-level management and board, who then can make informed final decisions based on professional advice, he notes.

Board members with communications background can improve pharma companies’ comms-related decisions, Hunter says. He adds: such an approach is uncommon in the wider industry but such a simple consideration that companies can make.

Connecticut-based BioXcel Therapeutics announced a win for artificial intelligence in the pharmaceutical industry. The U.S. Food and Drug Administration (FDA) has approved a sublingual film drug that aims to reduce the occurrence of agitation episodes in patients diagnosed with bipolar disorder or schizophrenia. Igalmi (dexmedetomidine) is an easy-to-administer, fast-acting drug that has revived a decades-long approval stagnation in the acute treatment of schizophrenia and bipolar disorder.

Developed using BioXcel’s AI platform and referred to as BXCL501, Igalmi works as quickly as 20 minutes post-administration. This rapid onset is critical for schizophrenia and bipolar disorder patients, as the disorders are trademarked by agitation states that affect up to one-quarter of patients and occur an average of 10 to 17 times a year. Agitative states can require medical attention to bring resolution, meaning a treatment has been long-awaited by patients and medical caregivers.

Dr. John Krystal, a professor at the Yale School of Medicine and Chair of the school’s Department of Psychiatry, commented on the previously unmet need. “There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for healthcare professionals to treat,” Krystal said. 

Schizophrenia and bipolar disorder patients are estimated to exceed seven million in the U.S. alone. While 75% of these patients do not experience agitation episodes that would require care, the number affected remains alarming.

The company published data from the Phase III SERENITY II clinical trial early this year, demonstrating efficacy and safety. The trial was double-blinded, randomized and placebo-controlled, focusing on those with diagnosed bipolar I or bipolar II. The SERENITY I trial, also Phase III, was kept under the same conditions and criteria.

Primary endpoints for the studies were based upon the average score change from baseline, according to the Positive and Negative Syndrome Scale-Excited Component (PEC) after dosage. Efficacy based upon the timeline of this change, in comparison to placebo, was the secondary endpoint. Each of these studies’ results contributed to the FDA’s green light.

Despite having a warning label that mentions incompatibility with operating machinery, hypotension, orthostatic hypotension, advanced heart block, syncope and severe ventricular dysfunction, the adverse side effects in clinical trials have been minimal and mild in nature. These side effects were seen in less than 5% of participants.

Igalmi will advance towards commercial markets this quarter, heightening anticipation for patients and BioXcel researchers alike. Dr. Vimal Mehta, CEO of BioXcel, commented on the upcoming plans for commercialization in a press release.

“We are deeply grateful to our clinical trial participants, healthcare providers, researchers, and employees for contributing to this important new therapy. We believe IGALMI has significant market-changing potential,” Mehta said.

BioXcel focuses on how to approach neuroscience using an artificial intelligence platform. The novel technology is being investigated as a treatment for Alzheimer’s disease and major depressive disorder. Keeping in line with its orally administered drug trend, BioXcel is developing BXCL701, a treatment for aggressive prostate cancer and advanced solid tumors.