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July 28, 2020 Bioscience

Potential COVID-19 treatment enters Phase II trial 

IMAGE | Pixabay.com
By Michelle Tuccitto Sullo

A Guilford company is making progress with its drug candidate for treating patients with COVID-19.

AI Therapeutics, a biopharmaceutical company, indicated Monday it has started a Phase II clinical trial for LAM-002A, also known as apilimod dimesylate.

The company, which works to match existing drugs to potential new uses through the use of artificial intelligence, will be collaborating with Yale University on the trial. LAM-002A was developed as a cancer treatment drug.

“We all want to do our part to allow the people we love to get back to work, school, and play,” said Jonathan Rothberg, AI Therapeutics’ co-founder, in Monday’s announcement. “At AI Therapeutics we feel we need to do all we can to make sure our drug, LAM-002, has the best shot to help, and working with Yale is the perfect place to start.” 

The coronavirus as of early this week had claimed some 149,000 lives in the United States alone.

The plan is to enroll up to 142 outpatients to determine if LAM-002A reduces the virus in subjects who have COVID-19 and if it is safe, effective and well-tolerated. The study will be random, double-blind and placebo controlled. Researchers also will evaluate patient hospitalization, mortality and oxygen saturation.

According to the company, LAM-002A has already demonstrated potent in vitro antiviral activity against COVID-19 and shows potential to become part of a combination of therapies used to fight it.

As the clinical trial progresses, AI will work to make the drug accessible, with 70,000 doses ready to go and another 70,000 on the way. 

Dr. Murat Gunel, who chairs the company’s scientific advisory board and teaches at Yale, said the drug’s safety has been demonstrated already in more than 700 healthy subjects and patients with inflammatory and malignant conditions.

“Its safety profile and effectiveness provide a strong rationale for urgently evaluating this drug in COVID-19 patients, who have few options to slow the progression of the disease,” Gunel said. 

Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.

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