CytoDyn Inc. has announced breakthrough findings from three preclinical studies showing that its investigational drug leronlimab successfully reversed liver fibrosis in multiple mouse models. The studies, conducted in partnership with SMC Laboratories, demonstrated statistically significant improvements compared to control groups, with p-values below 0.01 across all trials.
Promising Results in Multiple Fibrosis Models
The research encompassed two distinct experimental approaches. The first two studies, completed in late 2024, utilized the STAM™ mouse model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis. These mice received streptozocin at birth and were maintained on a high-fat diet from weeks four through twelve. The third study, concluded in January 2025, examined fibrosis reversal in mice exposed to carbon tetrachloride from birth to day 35.
Leronlimab, a humanized IgG4 monoclonal antibody, works by targeting CCR5 receptors on hepatic stellate cells. This mechanism of action appears to be key in reversing established liver fibrosis, addressing a significant unmet medical need in hepatology.
Expert Perspectives on Clinical Significance
"The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology," stated Dr. Melissa Palmer, FAASLD, CytoDyn's Lead Consultant in Hepatology. She emphasized the importance of leronlimab's demonstrated ability to bind to CCR5 receptors and reverse established liver fibrosis.
Dr. Jacob Lalezari, CEO of CytoDyn, expressed optimism about the findings: "We are very encouraged by these initial findings, which add to the growing body of evidence that leronlimab's core mechanism of action could translate into meaningful clinical benefits across multiple medical conditions."
Future Development and Partnership Opportunities
While CytoDyn maintains its primary focus on oncology objectives for 2025, the company is actively seeking partnerships to advance leronlimab's development in treating fibrosis. The potential applications extend beyond liver fibrosis to include other organs such as the lungs and heart.
The company is currently engaged in discussions with several third parties to explore potential synergies and partnership opportunities. These collaborations could be crucial in expanding the clinical development pipeline and investigating leronlimab's broader therapeutic potential in treating various forms of organ fibrosis.
