Yale's School of Medicine collaborated with AI Therapeutics in developing clinical drug trials for treating coronavirus. The drug they've been working with is apilimod, which had been a candidate for cancer therapy a few years ago.
Phase 1 of the drug trials just finished and have proved to be safe so far. The apilimod drug, LAM-002A was observed to inhibit SARS-CoV-2. The team's findings were recently published in the journal Nature.
During previous studies, over 700 patients with follicular lymphoma, an autoimmune disease, were safely treated LAM-002A. Afterward, the Food & Drug Administration (FDA) gave the drug a Fast Track Status and Orphan Drug Designation for treating lymphoma.
For Yale's clinical study, Phase II will include treatment for coronavirus. They will have about 150 COVID-19 patients enrolled in the study to test how effective the drug is as an inhibitor of the virus.
Phase 1 of the study included screening over 12,000 drugs for two different strains of coronavirus. LAM-002A proved to be the most effective. About 100 molecules were found to inhibit the virus from replicating from 21 existing drugs.
Meanwhile, a separate group of researchers also published a study where they effectively treated coronavirus-infected human lung cells with the same drug. During this study, an international team identified 87 drugs and compounds that had antiviral efficacy.
Combined Treatment With Remdesivir
At AI Therapeutics, they saw the drug lower levels of the virus in the body. Combining LAM-002A with remdesivir proved to be even more effective. The company's co-founder, Dr. Jonathan Rothberg said, 'We have 50,000 pills [of LAM-0002A] ready to go, we have a drug that has been shown to be safe in 800 patients, and we just made a commitment for 110,000 more pills and material for 5 Million more.'
Earlier this summer, Gilead conducted clinical trials of their patented drug remdesivir which involved around 6,000 patients. The 5-day and 10-day dose trials proved that the drug was an effective anti-viral drug and continues to be used for treating patients with coronavirus.
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Effective Treatment
Professor Murat Gunel from Yale University said, 'LAM-002A holds promise to be a powerful new therapy for COVID-19 patients to prevent progression of [the] disease, hopefully avoiding the need for hospitalization.' The team will soon be testing the clinical drug on patients already infected with the virus but Gunel hopes they can expand trials to see if LAM-002A would be effective in protecting people from exposure to coronavirus. Gunel hopes to test if high-risk populations such as poor communities, health care facilities, and nursing homes can effectively be treated with the drug as well.
The team continues to hope that the drug will be effective in treating coronavirus since the development and availability of vaccines might not happen until next year summer. Charles Dela Cruz, Director of the Center for Pulmonary Infection Research at Yale University said, 'We are delighted to be partnering with AI Therapeutics to see if LAM-002A can help ameliorate the devastating impact of this coronavirus pandemic on our society.'
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