Vancouver-based biotechnology company CytoDyn Inc. says it’s expecting results by the end of the month from a pair of clinical trials to test the effectiveness of one of its treatments on COVID-19.
In March, the company announced that it would seek permission from the Food and Drug Administration to conduct a Phase 2 trial of its signature product, “leronlimab,” on COVID-19 patients. Leronlimab is an antibody that binds to a receptor called CCR5 on certain immune cells.
The drug is intended to combat HIV infection — it’s also currently going through the FDA approval process for that purpose — but the company theorized that it could help alleviate COVID-19 symptoms due to a secondary effect: When the antibodies bind to certain T-cells, they slow the rate at which those cells produce inflammatory cytokines — signaling molecules that cause inflammation.
COVID-19 typically results in flu-like symptoms, but one of the potential complications is a major inflammatory response in the lungs, leading to a potentially fatal condition called Acute Respiratory Distress Syndrome. CytoDyn is hoping that leronlimab’s anti-inflammatory properties could prevent the lung inflammation from spiraling out of control.
The FDA approved CytoDyn’s trial protocol, and the company announced in mid-June that it had reached its target enrollment of 75 patients for a Phase 2 trial to evaluate the efficacy of leronlimab for mild to moderate cases of COVID-19. Enrollment is also being conducted for a second trial to test the drug on critical cases, according to CytoDyn CEO Nader Pourhassan.
The trial was scheduled to last two weeks, so it should be complete by now, Pourhassan said. CytoDyn expects to receive the results later this month, he said, and he hopes to see results from both trials at the same time.
The trials are double-blind studies, so there won’t be any hint about the drug’s performance until the results are available. But 60 patients have separately been treated with leronlimab through the FDA’s Emergency Use Investigational New Drug process, Pourhassan said, which allows physicians to request the use of experimental drugs for individual cases.
The results in those cases have been encouraging, Pourhassan said, with several patients showing a reduced cytokine storm — the reaction that causes the severe lung inflammation. But the clinical trial results will provide a much clearer picture.
“The whole world is eagerly waiting for these kinds of results from any product that is being tested on COVID-19,” he said.
If the trial results are also positive, the next step would be up to the FDA, Pourhassan said. If the drug proves to be effective and the FDA approves its use, CytoDyn plans to be ready; the company announced Friday that it has reached an agreement with manufacturer American Regent to distribute the drug.