Leronlimab 14-Week, NASH Clinical Trial Met Primary Endpoint (PDFF) and Secondary Endpoint (cT1) for Per Protocol Population in 350 mg Weekly Dose
CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.
The primary endpoint, PDFF (proton density fat fraction), is an MRI-derived biomarker for fatty deposition, while the secondary endpoint, cT1, is an iron-corrected T1 mapping representative of liver inflammation and fibrosis. These two values are used to evaluate the risk of NASH. CytoDyn’s Phase 2 clinical trial compared the changes from baselines in these endpoints. The leronlimab 350 mg dose versus placebo comparison for the primary endpoint PDFF was statistically significant. Leronlimab compared to placebo also reached near significance for the secondary endpoint cT1. There were no significant differences in treatment emergent adverse events between leronlimab and placebo groups.
Christopher P. Recknor, M.D., CytoDyn’s Senior Executive Vice President of Clinical Operations, stated, “We thank our sites, vendors and staff who helped make this trial possible. We are in the process of analyzing biomarker data including CCR5 haplotype information to better understand responder rates and mechanism of action. Given 5% of the world population is estimated to have NASH with 20% progressing to cirrhosis, this signal gives hope for a therapeutic intervention for this disease.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We wish to thank our entire NASH team led by Dr. Recknor, who has done a phenomenal job conducting this study. We are very excited about these results and the potential for helping the millions of individuals effected by NASH across the world. The main focus after seeking approval in the U.S. will be the UK, Canada, Brazil, and the Philippines. Hitting our primary endpoint in both ITT and per protocol (PP) and secondary endpoint in PP with such short trial (14-week trial as compared to usually 24 to 32-week NASH trials) is a very strong statement of leronlimab’s potential. We believe we have a unique drug with tremendous opportunities.”
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