CytoDyn Begins Preclinical MASH Study, Results Due Fall 2024

VANCOUVER, Washington, June 27, 2024 — CytoDyn Inc. (OTCQB: CYDY), a biotechnology company focused on developing leronlimab, a CCR5 antagonist with potential applications in various therapeutic areas, announced the initiation of a new preclinical study in collaboration with SMC Laboratories, Inc. The study aims to evaluate leronlimab’s effectiveness in treating metabolic-associated steatohepatitis (MASH), with preliminary results anticipated by fall 2024.

This new preclinical study follows a previous MASH study by CytoDyn, which indicated a statistically significant benefit of leronlimab at a 350 mg dose. The upcoming study by SMC Laboratories aims to further investigate the optimal dosing levels of 350 mg and 700 mg. Additionally, the study will examine the potential benefits of combining leronlimab with Resmetirom, an FDA-approved drug, in preventing and reversing liver fibrosis over a twelve-week period using a mouse model.

Dr. Jacob Lalezari, CEO of CytoDyn, expressed optimism about the study, emphasizing its dual objectives: to determine the appropriate dosing and efficacy of leronlimab, and to explore potential partnership opportunities in the MASH treatment space. Although CytoDyn’s primary focus in the coming months will be on oncology and inflammation, Dr. Lalezari highlighted leronlimab’s potential as a significant therapeutic agent for MASH, both as a standalone treatment and in combination therapy.

CytoDyn is a clinical-stage biotechnology firm dedicated to the development and commercialization of leronlimab. This investigational humanized IgG4 monoclonal antibody targets the C-C chemokine receptor type 5 (CCR5), a protein found on certain immune system cells implicated in various disease processes. The company has explored leronlimab across several therapeutic areas, including infectious diseases, cancer, and autoimmune conditions.

The study’s results could pave the way for CytoDyn to establish partnerships and potentially expand the applications of leronlimab in the treatment of MASH, a condition characterized by liver inflammation and fibrosis. With the promising data from earlier studies, the company is keen to validate these findings and explore new therapeutic avenues.

In summary, CytoDyn Inc. is advancing its research on leronlimab by initiating a preclinical study with SMC Laboratories to elucidate the optimal dosing and combination therapy potential for treating MASH. The study's findings are eagerly awaited, as they will inform future strategies and partnership opportunities for CytoDyn in the field of liver disease.