CytoDyn enlists 293 patients for second interim analysis of leronlimab in Phase 3 COVID-19 trial

CytoDyn Inc (OTCQB:CYDY), a biotechnology company developing leronlimab (PRO 140) for multiple indications, revealed on Monday that it has achieved the enrollment of 293 patients with severe-to-critical coronavirus (COVID-19) symptoms, meeting the criteria for a second interim analysis by the Data Safety Monitoring Committee (DSMC).  The Vancouver, Washington-based company said that after the first interim analysis, the DSMC requested a second one of all data after enrollment had reached 293 patients or 75% of the total patients for the trial.  Around five weeks ago, the DSMC completed the first interim analysis on 195 patients – or 50% of the 390 planned patients – and recommended the trial continue without modification to achieve the primary endpoint. The DSMC asked for another interim analysis when the company enlisted 75%, or 293 patients to review patient mortality and other clinical outcome data. READ: CytoDyn files protocol with FDA for Phase 2 leronlimab trial in 'long-hauler' coronavirus patients “In addition to filing our biologics license applications in Canada and the UK for HIV, the company is in full swing to obtain full enrollment in the Phase 3 COVID-19 trial before year-end and initiate our Phase 2 trial for COVID-19 patients with multiple long-hauler symptoms and perhaps complete enrollment in 4-6 weeks.” CEO Nader Pourhassan said in a statement. 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.” “We are very appreciative of the all-out effort by our clinical operations team (especially Mr Brian Brothen, the company’s SVP of Global Oncology, and Dr Kush Dhody from Amarex) and the clinical sites to expedite enrollment in this important trial and are hopeful the DSMC can complete their second interim analysis quickly,” added Dr Pourhassan. “We continue to advance enrollment to achieve the trial’s planned 390 patients and are currently evaluating the ability to conduct an interim analysis as soon as possible. In the meantime, if the pace of enrollment we have experienced in the last two weeks continues, we will have the CD12 enrollment completed before the end of the year. These are exciting times for the company.”     Meanwhile, Dr Pourhassan also noted that CytoDyn is about to enroll its first patient in its clinical trial of its flagship drug leronlimab as a treatment for the liver condition non-alcoholic steatohepatitis (NASH). Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive