CytoDyn Inc. (OTCQB:CYDY) has announced that its contract research organization (CRO) in Brazil, Albert Einstein Israelite Hospital, has met with the Brazilian Health Regulatory Agency (ANVISA) and received its agreement to modify the CD16 trial for critically ill coronavirus (COVID-19) patients.
Following ANVISA’s authorization, the company said it will submit the revised protocol for CD16 providing for a reduction in total enrollment from 330 to 126 patients, with interim efficacy analysis by a data safety monitoring board (DSMB) after 40% of patients are enrolled and have completed follow-up to Day 28.
“We are optimistic that our CRO in Brazil will be able to enroll 51 patients and conduct an interim analysis of the results in 1Q 2022, with the potential for meeting the primary endpoint at the time of interim analysis,” CytoDyn’s president and CEO Dr. Nader Pourhassan said in a statement.
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In the trial, CytoDyn said patients will be randomized in a 1:1 ratio to receive up to four weekly doses of 700 mg of its flagship drug leronlimab or placebo via intravenous (IV) infusion.
By comparison, in the previous CD12 trial (a phase 3 trial for COVID-19 severe-to-critical ill patients) in the US, patients received only two weekly doses of 700 mg of leronlimab via subcutaneous injections.
The company noted that the subgroup analyses of 62 critically ill patients in the CD12 trial showed an 82% survival benefit at Day 14 after two doses of leronlimab on Day 0 and Day 7 (Odds Ratio 0.09 (CI 0.01, 0.72), p-value 0.0233) vs. standard-of-care plus placebo.
The survival benefit fell from 82% after 2 more weeks to 30% after four weeks. The survival rate on Day 28 could be much better with four 700mg, IV doses of leronlimab administered on Day 0, 7, 14, and 21, it added.
“The primary endpoint in this study was based on the valuable information we had generated from the past CD12 trial. The p-value for length of hospital stay for the critically ill patients who were on invasive mechanical ventilator or ECMO was 0.005,” Pourhassan added.
“The primary endpoint of the CD16 trial in Brazil is Time to Recovery, which is similar to this endpoint. Due to this past result from CD12 which was obtained with two subcutaneous doses of leronlimab, we believe four doses via IV will give us an excellent chance of success.”
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel monoclonal antibody targeting the CCR5 receptor.
Contact the author at stephen.gunnion@proactiveinvestors.com