Altimmune Completes Phase 2b Pemvidutide Trial Enrollment for MASH

Altimmune, Inc., a clinical-stage biopharmaceutical company, has announced the completion of patient enrollment in its Phase 2b IMPACT trial, which evaluates the safety and efficacy of pemvidutide in treating metabolic dysfunction-associated steatohepatitis (MASH). The IMPACT trial is a significant milestone as it will be the first incretin-based study to report on a biopsy-driven fibrosis endpoint within a 24-week period. The company anticipates top-line efficacy data to be available by the second quarter of 2025.

The President and CEO of Altimmune, Dr. Vipin K. Garg, expressed excitement about this development and highlighted the importance of the upcoming FDA End-of-Phase 2 meeting for their obesity program, scheduled for early November 2024. Dr. Garg noted that the organization's plans include filing Investigational New Drug (IND) applications for pemvidutide for up to three additional indications starting in the fourth quarter of 2024. These initiatives are expected to significantly enhance the profile of pemvidutide in the metabolic disease sector and increase its long-term value.

Dr. Mazen Noureddin, a Professor of Medicine at Houston Methodist Hospital and Principal Investigator of the IMPACT trial, emphasized the potential advantages of pemvidutide over other treatments for MASH due to its ability to combine liver effects and weight loss. He expressed optimism for the trial results, which he believes could offer significant improvements in treating the condition.

Dr. Garg also mentioned that the company is looking forward to aligning with the FDA on its Phase 3 clinical development plan for pemvidutide in treating obesity at the End-of-Phase 2 meeting. He highlighted that the proposed program leverages the unique attributes of pemvidutide, which could benefit patients who have obesity, elevated liver fat, and high serum lipids while preserving lean mass.

Altimmune also plans to file IND applications for pemvidutide in three additional indications, with the first submission expected by the fourth quarter of 2024. Details about these indications will be disclosed following further alignment with the FDA. The company is already preparing for the first trial, which is expected to start in the first half of 2025. Dr. Scott Harris, Chief Medical Officer of Altimmune, stated that the company believes there is a strong scientific rationale for developing pemvidutide for these additional indications, which are areas of high unmet medical needs. He noted that the balanced GLP-1/glucagon dual agonism of pemvidutide could offer a differentiated approach compared to other treatments.

Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist designed for treating obesity and MASH. The activation of these receptors is believed to mimic the combined effects of diet and exercise, aiding in weight loss, appetite suppression, and increased energy expenditure. Glucagon also plays a role in hepatic fat metabolism, leading to rapid reductions in liver fat and serum lipids. Clinical trials have shown that pemvidutide can lead to significant weight loss, reduced triglycerides, LDL cholesterol, liver fat content, and blood pressure while maintaining lean mass. The FDA has granted Fast Track designation to pemvidutide for treating MASH. The drug has recently completed the MOMENTUM Phase 2 obesity trial and is currently being studied in the ongoing IMPACT Phase 2b MASH trial.

Altimmune is committed to advancing pemvidutide through clinical trials and regulatory processes to address the significant unmet needs in metabolic diseases. The company's efforts are expected to provide new therapeutic options for patients with obesity and MASH, as well as other indications that will be explored in upcoming studies.