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June 16, 2020 Bioscience Notebook

Guilford’s AI Therapeutics gets FDA green light for COVID-19 trial; Isoplexis wins $2M NIH grant

IMAGE | Pixabay.com
By Natalie Missakian

Federal regulators have green-lighted Guilford’s AI Therapeutics to begin a clinical trial to test if its experimental drug for non-Hodgkin lymphoma and ALS could also work against COVID-19.

Co-founder and bioscience entrepreneur Jonathan Rothberg announced on Twitter Monday that the company had received a “may proceed letter” from  the U.S. Food & Drug Administration. AI Therapeutics is one of seven companies housed in Rothberg’s 4Catalyzer incubator in Guilford.

The trial will start this month and could wrap up by August, Rothberg said in an email Monday afternoon. He said the company has committed to producing enough of the drug product for 5 million doses. 

Rothberg / Contributed photo

Murat Gunel, MD, professor of genetics and neuroscience at Yale School of Medicine, will lead the study. 

In April, a research group with the Sanford Burnham Prebys Medical Discovery Institute identified the drug, apilimod (LAM-002), as one of four it believed represented the “best new approaches for a near-term COVID-19 treatment.” 

In their study, the researchers identified  30 existing drugs that stopped the growth of the new coronavirus, SARS-CoV-2, in lab tests. 

“Almost all of the drugs are entirely different from those currently being tested in clinical trials, and weren’t previously known to hold promise for COVID-19 treatment,” the researchers said in an April news release. “The new candidates expand the number of “shots on goal” for a potential COVID-19 treatment and could reach patients faster than drugs that are created from scratch.”

The study identified the drugs by screening more than 12,000 from a library of existing drugs that have been approved by the FDA for other diseases or have been tested extensively for human safety, the news release said. 

The library was created by Scripps Research with support from the Bill & Melinda Gates Foundation. 

Apilimod and three others could enter human trials immediately since they had already been deemed safe for humans in previous studies at doses likely to be effective against COVID-19, the researchers said.  

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Branford’s IsoPlexis has landed a $2 million national grant to expand development of a cellular platform for analyzing the effects of the inflammatory immune response on Alzheimer’s Disease progression. 

IsoPlexis said its system will allow for the sensitive detection of responses from various immune cells as biomarkers for early stage diagnosis and monitoring of inflammatory neurodegenerative diseases. 

“Immune-driven neuroinflammation is a significant contributor to the pathogenesis of diseases such as Alzheimer's,” said CEO Sean Mackay in a statement. “There is an urgent ongoing need for the accelerated development of novel therapeutics and diagnostics.”

The Phase 2 Small Business Innovation Grant was awarded from the National Institute on Aging of the National Institute of Health.  

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New Haven’s BioXcel Therapeutics Inc. said last week it had enrolled its first patient in a clinical trial to test if its anti-agitation drug can treat opioid withdrawal.

BioXcel said the Phase 1b/2 trial will enroll roughly 125 patients with opioid use disorder who are physically dependent on opioids. 

BXCL 501, a thin-film formulation of an older drug known as dexmedetomidine (“Dex”), dissolves in the mouth similar to a mouthwash strip. BioXcel is also testing it to treat agitation in patients with schizophrenia and bipolar disorder. 

CEO Vimal Mehta said the drug may offer advantages over the current standard of care and provide patients with a non-opioid therapy to alleviate the physiological symptoms of withdrawal.

“As the leading cause of death in the U.S. for individuals under the age of 50 years old, opioid abuse is a widespread problem that has been heightened by the COVID-19 pandemic,” Mehta said in a statement. “In order to avoid the painful symptoms associated with opioid withdrawal, individuals often continue to abuse these drugs or relapse, highlighting the need for better treatments to halt the cycle of addiction.”

The study will assess withdrawal symptoms over a 10-day period for patients taking ascending doses of the drug against a placebo.

BioXcel expects to report results in early 2021. 

Contact Natalie Missakian at news@newhavenbiz.com.

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