CytoDyn: Leronlimab Weekly Use for 14 Weeks in NASH Trial Produces Fibrosis Reduction

 CytoDyn. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today reported data from its trial treating NASH (nonalcoholic steatohepatitis) open label with leronlimab.

Leronlimab open label NASH results continue to show reductions in fat and fibrosis suggestive of a potential therapy not only for NAFLD (Non-Alcoholic Fatty Liver Deposit) but also in NASH. Fat reductions by proton density fat fraction PDFF up to 45% along with reductions in fibrosis up to 8% by CT1 were noted from baseline after just 14 weeks of treatment. The reductions in fibrosis were seen in both severe and mild-moderate NASH cases.

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, stated, “Though numerous drugs have been evaluated in clinical trials, there have been no approvals by the U.S. Food and Drug Administration for treating biopsy-proven NASH. We are encouraged by the continued results and look forward to presenting the full trial results after database lock. We believe this reported data is an exciting step forward in research and demonstrates the potential of leronlimab for inhibiting the liver fibrosis associated with NASH. CytoDyn will now file for Fast Track Designation for both the indications of NASH and NAFLD. Once the full results are reported, which we anticipate to be available in mid-December, we may proceed to file a Phase 3 protocol with the FDA and request accelerated approval.”

https://www.biospace.com/article/releases/leronlimab-350-mg-weekly-use-for-14-weeks-in-open-label-arm-of-nash-trial-produces-fibrosis-reduction-as-high-as-93-msec-amongst-first-15-patients-with-average-reduction-of-24-msec/