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CytoDyn Announces Start of Preclinical MASH Study, Results Expected in Fall 2024

CytoDyn Announces Start of Preclinical MASH Study, Results Expected in Fall 2024

CytoDyn Inc., a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that its preclinical MASH (NASH; recently renamed metabolic dysfunction–associated steatohepatitis, or MASH) study with SMC Laboratories, Inc.  has commenced, with results expected in the fall of 2024.

CytoDyn believes its prior MASH study demonstrated a statistically significant benefit of leronlimab at a dosing level of 350 mg. To clarify the optimal dosing and evaluate the potential for combination therapy, SMC will be conducting a twelve-week preclinical mouse study evaluating both 350 and 700 mg dose levels, alone and in combination with Resmetirom, a drug recently approved by the FDA. The study will evaluate leronlimab’s potential role in preventing and/or reversing liver fibrosis.

CytoDyn’s CEO, Dr. Jacob Lalezari, stated, “in addition to clarifying dosing and efficacy, the goal of this study is to eventually use the results to pursue partnerships in the MASH space. Although CytoDyn will be primarily focused on oncology and inflammation in the coming months, we do believe that leronlimab could have a significant role in the treatment of MASH, whether as a standalone therapeutic or in a combination therapy approach.”

About CytoDyn

CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions.

July 1, 2024

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