Cytodyn Inc (CYDY)

[JPG77]

Early NASH results were incredibly good and promising.

CytoDyn Reports Preliminary Results from First Five Patients in Phase 2 NASH Open Label Leronlimab Trial. Lower Fatty Deposits in All 5 Patients by as Much as 45% and Lower Fibrosis in 4 Patients by as Much as 10% Compared to Baseline.

VANCOUVER, Washington, Nov. 03, 2021 (GLOBE NEWSWIRE) -- 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 today preliminary results from the first five patients treated with leronlimab in its Phase 2 trial for NASH (nonalcoholic steatohepatitis) open label. These preliminary findings from five patients treated with leronlimab suggested fatty deposits were lowered on all 5 patients by as much as 45%, as compared to the baseline measurement. In addition, fibrosis was also lowered by as much as 10%, in 4 out of 5 patients as compared to the baseline measurement (one patient exhibited no change in fibrosis).

The Phase 2 trial for 90 patients is designed to test whether leronlimab may inhibit the devastating liver fibrosis associated with NASH. As previously reported, the Company’s preclinical study demonstrated strong positive data, highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to NASH. Inhibition of CCR5 has been shown to be effective in reducing fibrosis in animal models of NASH liver fibrosis.

Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease in adults worldwide. There are currently no U.S. Food and Drug Administration (FDA) approved treatments for NASH, and it is expected to be the number one cause of liver transplants in 2020.1 About 30 to 40 percent of adults in the U.S. are living with NAFLD, and 3 to 12 percent of adults in the U.S. are living with NASH.2

Chris Recknor, M.D., Senior Executive Vice President of Clinical Operations, commented, “We are encouraged by the preliminary results from the open label portion of our NASH trial. The CT1 reduction from baseline for these patients is approximately 40 msec, which would be consistent with an observed reduction in fibrosis on biopsy. We expect data lock in December with results from the 700 mg double blind placebo-controlled part 1 and the remaining part 2 open label with 350 mg. We are working on a new Phase 2b/3 protocol to include biopsy to start in January 2022 with our new CRO, Cato Research LLC (CATO SMS), which has extensive experience with NASH trials.”

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, concluded, “We believe these early findings represent a very significant therapeutic opportunity for patients suffering from this disease, encouraging us to aggressively pursue a NASH indication with potential for Breakthrough Therapy designation (BTD). Our team is currently preparing the BTD application for 350 mg arm, which could include 10 patients’ data by mid-November. We are also very optimistic for our 700 mg arm, which was double blinded; and we hope to unblind the data and announce those results in early December.”