CytoDyn Announces Preliminary Findings in Study with SMC Laboratories

Rhea-AI Summary

CytoDyn Inc. (OTCQB: CYDY) has announced preliminary findings from a preclinical study conducted by SMC Laboratories on leronlimab, its CCR5 antagonist. The study assessed optimal dosing for MASH (Metabolic dysfunction-Associated Steatohepatitis) and potential synergies with Resmetirom. Key findings include:

1. Leronlimab monotherapy (700 mg) showed statistically significant fibrosis reversal compared to control (p<0.01).
2. Dose-dependent antifibrotic activity was observed, with 700 mg performing better than 350 mg.
3. Leronlimab (700 mg) appeared to have better anti-fibrotic activity than Resmetirom (p=0.057).

Dr. Jacob Lalezari, CEO of CytoDyn, expressed excitement about the results, stating they confirm leronlimab's potential to benefit patients with various medical concerns. The company is in discussions with SMC Laboratories regarding next steps, including supplemental studies to expand on these findings and advance their clinical pipeline.

Positive

• Leronlimab (700 mg) demonstrated statistically significant fibrosis reversal compared to control
• Dose-dependent antifibrotic activity observed, with higher dose (700 mg) performing better
• Leronlimab (700 mg) showed better anti-fibrotic activity compared to the only currently approved MASH therapy, Resmetirom

Negative

• None.

VANCOUVER, Washington, Sept. 24, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a preliminary review of results from its preclinical study with SMC Laboratories.

SMC Laboratories, a company specializing in preclinical drug efficacy evaluations using various models of inflammation and fibrosis in mice, conducted a study that assessed the optimal dosing of leronlimab in the MASH setting and potential synergies with Resmetirom, the only currently approved therapy for the treatment of MASH. A preliminary review of the study results has led to several encouraging findings, as follows:

1. Leronlimab monotherapy (700 mg) demonstrated statistically significant fibrosis reversal compared to an isotype IgG4 control arm (p<0.01);
   
   
2. Leronlimab monotherapy appeared to demonstrate dose-dependent antifibrotic activity, with leronlimab 700 mg performing better at reversing liver fibrosis compared to leronlimab 350 mg; and
   
   
3. Leronlimab monotherapy (700 mg) appears to have better anti-fibrotic activity compared to Resmetirom (p=0.057).
   

“These initial results are very exciting and confirm our belief that leronlimab has the potential to be materially beneficial for patients suffering from a number of medical concerns,” said Dr. Jacob Lalezari, CEO of CytoDyn. “While additional research is necessary to confirm and explore these findings further, we are very encouraged about the potential for leronlimab to support therapeutics meant to address MASH and specifically fibrosis and related complications in the liver.”

CytoDyn is in discussions with SMC Laboratories regarding next steps – including supplemental lab studies to expand on these promising findings, further explore potential synergies and continue to advance the Company’s clinical pipeline.

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, oncology, and autoimmune conditions.

Note Regarding Forward-Looking Statements

This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.

CONTACT

CytoDyn
Investor Relations
CytoDyn Inc.
ir@cytodyn.com

FAQ

What were the key findings of CytoDyn's preclinical study with SMC Laboratories for leronlimab (CYDY)?

The key findings were: 1) Leronlimab 700 mg showed significant fibrosis reversal compared to control, 2) Dose-dependent antifibrotic activity was observed, and 3) Leronlimab 700 mg appeared to have better anti-fibrotic activity than Resmetirom, the only approved MASH therapy.

How did leronlimab (CYDY) perform compared to Resmetirom in the MASH study?

Leronlimab monotherapy (700 mg) appeared to have better anti-fibrotic activity compared to Resmetirom, with a p-value of 0.057, suggesting a potentially significant advantage in treating liver fibrosis associated with MASH.

What are CytoDyn's (CYDY) next steps following the preliminary results of the leronlimab study?

CytoDyn is in discussions with SMC Laboratories regarding next steps, including conducting supplemental lab studies to expand on the promising findings, further explore potential synergies, and continue advancing the company's clinical pipeline for leronlimab.