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Trial Testing Lymphoma Drug to Treat Covid-19

SARS-Cov-2 virus

Scanning electron microscope image of SARS-Cov-2 virus, responsible for Covid-19 infections (NIH.gov)

28 July 2020. A clinical trial is underway testing an experimental drug for lymphoma and neurological disorders also as a treatment for early Covid-19 infections. AI Therapeutics Inc., a biopharmaceutical company in Guilford, Connecticut is conducting the study with Yale University Medical School, testing the company’s drug code-named LAM-002A among patients newly diagnosed with Covid-19.

AI Therapeutics discovers chemical and biological therapies for cancer and rare diseases with computational techniques, including deep learning algorithms. The company says its technologies use next-generation sequencing, genome editing, gene-expression profiles, and multiple-drug screening to train its algorithms that predict the potency of known biologics and drug compounds against disease properties.

LAM-002, also known as apilimod, is AI Therapeutics’ treatment candidate in mid-stage clinical trials for B-cell non-Hodgkin lymphoma, both on its own and in combination with other drugs. The small molecule drug works by blocking an enzyme known as phosphatidylinositol-3-phosphate 5-kinase, or PIKfyve, that promotes viral infections, such as those from SARS-CoV-2 viruses responsible for Covid-19.

Researchers from AI Therapeutics, then known as LAM Therapeutics, used the company’s algorithms to discover, and later show in lab and animal tests that limiting PIKfyve enzymes with LAM-002 kills B-cell non-Hodgkin lymphoma cells. Those findings led to the company’s current clinical studies of LAM-002 with that type of lymphoma. The company’s technology also highlighted LAM-002’s potential as a treatment for the neurological disorders amyotrophic lateral sclerosis, or ALS, and frontotemporal dementia, now in early-stage trials.

AI Therapeutics applied its algorithms to discovering drugs to treat Covid-19 among known biologics and compounds, with results published last month in the journal Cell and on 24 July in Nature. In both studies, thousands of known drugs were screened for their ability to disrupt infections from SARS-CoV-2 viruses, with LAM-002’s actions blocking PIKfyve enzymes seen as particularly effective in preventing lung infections. From those findings, AI Therapeutics developed an apilimod variation code-named LAM-002A as a Covid-19 treatment.

The company cites preclinical studies showing LAM-002A interferes with SARS-CoV-2 viruses entering and spreading through cells. Because LAM-002A uses a therapy mechanism different from other anti-viral drugs, AI Therapeutics says it may be a candidate for combination therapies, as well as working on its own.

The clinical trial is a mid-stage study assessing LAM-002A as a treatment among patients recently infected with Covid-19 infections. The study, conducted for now at Yale, is enrolling 142 participants testing positive for Covid-19 but with no more than mild symptoms. Other sites are expected to join the study. Participants are randomly assigned to receive five capsules of LAM-002A or a placebo taken twice a day for 10 days.

The study team led by Yale medical school professor Charles Dela Cruz, is looking primarily for changes in viral concentrations in participants’ nasal swabs after four days, compared to samples taken before the study. The researchers are also measuring viral concentrations after six, eight, 11, and 28 days, as well as watching for signs of adverse effects from the treatments. Because LAM-002 is already in trials for other disorders, it already established a safety record, and did not need a separate early-stage safety trial.

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