CytoDyn Inc (OTCQB:CYDY), a biotechnology company developing leronlimab (PRO 140) for multiple indications, revealed on Tuesday that the Data Safety Monitoring Committee (DSMC) had issued a positive interim analysis of leronlimab in the Phase 2b/3 registrational trial in patients with severe-to-critical coronavirus (COVID-19).
The Vancouver, Washington-based company said the interim analysis was performed on data from the first 195 (50%) of 390 planned patients.
The DSMC could have stopped the trial due to safety concerns, or asked for modifications. Instead, it asked CytoDyn to continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint. There will be another interim analysis when enrollment reaches 75% level (or 293 patients) to review patient mortality and other clinical outcome data between the two study arms — leronlimab versus placebo.
The trial enrollment is currently at 230 patients and CytoDyn is working to step up patient enrollment in the US and the UK to achieve the enrollment goal of 293 patients as quickly as possible, potentially in four-to-six weeks, with the goal of full enrollment (390) before year-end. Clinical trial sites in the UK are expected to initiate enrollment in the coming days, said the company.
In a statement, CytoDyn CEO Nader Pourhassan said: “We are grateful to the DSMC members for their diligence, guidance and support. We are very pleased by the DSMC’s recommendation and this encouraging interim analysis adding to the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients."
“Concurrently, we are seeking ongoing guidance from the US Food and Drug Administration (FDA) and regulatory agencies in other countries for a swift regulatory approval pathway for leronlimab to treat COVID-19.”
Pourhassan said the company will host an investment community webcast on October 20, at 2:00 pm PT/ 5:00 pm ET, to discuss the recommendations of the DSMC.
“We look forward to providing additional information during today’s webcast,” added Pourhassan.
CytoDyn’s Phase 2b/3 trial to evaluate the effectiveness and safety of leronlimab for patients with severe-to-critical COVID-19 is a two-arm, randomized, double-blind, placebo-controlled, adaptive design multicenter study.
In the study, patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo through a subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The company said the “primary outcome measured in this study is all-cause mortality at Day 28.”
Secondary outcomes measured include mortality at Day 14, change in clinical status of subject at Day 14, and change in clinical status of subject at Day 28, and change from baseline in the Sequential Organ Failure Assessment (SOFA) score at Day 14.
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