Vancouver-based biotechnology company CytoDyn Inc. on Tuesday detailed what it characterized as an “impressive” set of initial results from a recent clinical trial to test the safety and effectiveness of the company’s signature drug as a treatment for COVID-19 symptoms.
CytoDyn began developing the drug, Leronlimab, as an HIV treatment, but the company has also been testing it for several other potential applications, most recently as an anti-inflammatory agent to prevent some of the more life-threatening symptoms of the novel coronavirus.
The company received clearance from the Food and Drug Administration for two studies, one for patients with mild or moderate COVID-19 symptoms and another for patients with severe or critical symptoms. Both studies were randomized, double-blind and placebo-controlled clinical trials.
Tuesday’s results were from the mild-to-moderate symptom trial, which enrolled a total of 84 patients, 56 of whom received the drug and 28 of whom received a placebo. The initial results were focused on the safety of the drug; the company said the portion of the data pertaining to its effectiveness is still being analyzed.
Thirty-four percent of the patients treated with Leronlimab reported at least one “adverse event,” according to a press release from CytoDyn, compared with 50 percent of patients who received the placebo.
Six placebo patients experienced “serious adverse events,” compared with five patients on Leronlimab. One of the 84 patients died 33 days after enrollment due to “an event unrelated to Leronlimab,” the company said.
CytoDyn chief medical officer Scott Kelly said the company was pleased with the results, and he and other company officials touted the outcome as a positive sign of the drug’s potential.
“We are delighted to see a clinically meaningful reduction in (serious adverse outcomes) in the mild-moderate COVID-19 population,” senior science adviser Jacob Lalezari said in a statement. “Leronlimab has been extremely well tolerated in prior clinical trials in over 750 HIV+ patients. These new safety data are therefore consistent with our prior experience and very encouraging in the COVID-19 population.”
The efficacy data — and the results from the moderate-to-severe symptoms trail — are expected soon, the company said.
Leronlimab is an antibody that binds to a receptor called CCR5 on certain T-cells, which are part of the body’s immune system. The company’s primary goal in developing the drug was to shield T-cells from HIV, because the virus uses the CCR5 receptor to access and infect those cells.
But there’s a secondary effect, according to CytoDyn: As part of their immune system role, T-cells produce cytokines — signaling molecules that cause inflammation. When Leronlimab binds to the CCR5 receptor on T-cells, it appears to slow down the cells’ rate of cytokine production.
COVID-19 typically results in flu-like symptoms, but one of the complications is a major inflammatory response in the lungs, leading to a potentially fatal condition called Acute Respiratory Distress Syndrome. CytoDyn is theorizing that Leronlimab’s anti-inflammatory effect could prevent that reaction from spiraling out of control in COVID-19 patients.