CytoDyn Inc (OTCQB:CYDY) revealed patient safety data Tuesday from a Phase 2 coronavirus (COVID-19) trial of its drug leronlimab, which showed significantly lower adverse events than a placebo.
Of the 84 mild-to-moderate coronavirus patients in the study, 19 of the 56 treated with leronlimab reported an adverse event, compared to 14 of 28 who received a placebo. Five patients who received leronlimab reported a total of 8 serious adverse events (SAE), while 6 patients who received a placebo reported 11 SAEs.
None of the SAEs were related to leronlimab, the company said. One patient died 33 days after enrollment in an event unrelated to the drug.
“When considering treatment options in the Covid-19 population, it is paramount in treating this complex disease to provide patients with therapeutic options that minimize SAEs,” CytoDyn's chief medical officer Scott Kelly said in a statement. “We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes.”
CytoDyn expects to release the efficacy data from the study once the statistical analysis of primary and secondary endpoints is completed.
“We are very pleased to see clear advantages for the patients in this population in leronlimab versus placebo in regards to SAEs and look forward to announcing all of the efficacy endpoints very soon,” CytoDyn CEO Nader Pourhassan said.
“We are equally optimistic and look forward to the Data Safety Monitoring Committee’s upcoming review of the progress of our Phase 3 trial for Covid-19 patients with severe and critical indications and remain hopeful the therapeutic benefits for this patient cohort will be consistent with the results we saw from the administration of leronlimab to over 60 patients under eIND authorizations previously granted by the US Food and Drug Administration.”
Leronlimab has a history of being well-tolerated, according to CytoDyn senior science advisor, Jacob Lalezari.
“We are delighted to see a clinically meaningful reduction in SAEs in the mild-moderate COVID-19 population,” Lalezari said. “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 once-a-week subcutaneous administration of leronlimab is also convenient for patients and caregivers alike.”
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