Pemvidutide shows promise in metabolic disease trial

GAITHERSBURG, Md. - Altimmune, Inc. (NASDAQ:), a clinical-stage biopharmaceutical company, announced new findings from its Phase 1b trial of pemvidutide, suggesting potential benefits for patients with metabolic dysfunction-associated steatohepatitis (MASH). The trial data, presented at The Liver Meeting® of the American Association for the Study of Liver Diseases, indicated that weekly doses of pemvidutide led to significant reductions in cardio-inflammatory and hepato-inflammatory lipids, as well as atherosclerotic lipids.

The 12-week trial involved 94 subjects with obesity or overweight conditions and liver fat content (LFC) of 10% or higher. Participants received one of three dosages of pemvidutide or a placebo subcutaneously once a week. Results showed up to a 68.5% reduction in LFC from baseline, with decreases in total cholesterol and triglycerides by up to 12.2% and 44.6%, respectively. Notably, the study observed a rapid and significant reduction in small atherogenic LDL particles in subjects receiving the higher doses of pemvidutide.

Mazen Noureddin, M.D., MHS Director at Cedars-Sinai Medical (TASE:) Center Fatty Liver Program, highlighted the urgency for therapies that address not only MASH inflammation and fibrosis but also associated co-morbidities like cardiovascular disease. Dr. Vipin Garg, CEO of Altimmune, expressed optimism about pemvidutide's potential as a differentiated therapy for MASH, anticipating further results from the ongoing Phase 2b IMPACT trial in the second quarter of 2025.

Pemvidutide is a novel peptide-based GLP-1/glucagon dual receptor agonist, currently in development for the treatment of obesity and MASH. The drug has received Fast Track designation from the U.S. FDA for the treatment of MASH and has shown promising results in clinical trials, including weight loss with lean mass preservation and reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure.

Altimmune's focus on next-generation peptide-based therapeutics reflects a broader industry trend towards targeted treatments for complex metabolic diseases. The company's development of pemvidutide is part of its commitment to addressing the growing need for effective MASH therapies. This press release statement serves as the basis for the reported facts in this article.

In other recent news, Altimmune, a clinical-stage biopharmaceutical company, reported progress on its pemvidutide trials and shared its financial results. The company highlighted the full enrollment of the Phase 2b IMPACT trial for Metabolic Dysfunction Associated Steatohepatitis (MASH) and the alignment with the FDA on a Phase 3 program for obesity. Altimmune reported a net loss of $22.8 million for the quarter, with research and development expenses standing at $19.8 million. However, the company maintains sufficient funds of $139.4 million to support its operations into the first half of 2026.

In recent developments, Altimmune completed enrollment for its Phase 2b IMPACT trial of pemvidutide for MASH and expects top-line efficacy data by Q2 2025. The company is also planning an end of Phase 2 meeting with the FDA in Q4 2025. A comprehensive Phase 3 program for obesity, including four pivotal trials, has been aligned with the FDA. Altimmune is exploring additional indications for pemvidutide leveraging its glucagon properties and anticipates the initiation of a Phase 2 trial for an additional indication of pemvidutide in H1 2025.

Despite the reported net loss, the company remains optimistic about the potential of pemvidutide in the competitive metabolic disease market. However, no new strategic partnerships have been finalized in the past 12 months. The company's future developments will likely hinge on the successful completion of ongoing trials and the realization of pemvidutide's market potential.

InvestingPro Insights

Altimmune's recent clinical trial results for pemvidutide align with the company's position as a niche player in the biopharmaceutical industry, as highlighted by InvestingPro Tips. The positive data from the Phase 1b trial could potentially impact the company's financial outlook, which is currently characterized by some challenging metrics.

According to InvestingPro Data, Altimmune's market capitalization stands at $539.84 million, reflecting investor interest in the company's pipeline. Despite the promising trial results, it's worth noting that Altimmune is not currently profitable, with a negative P/E ratio of -6.0 for the last twelve months as of Q3 2024. This is consistent with the InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year.

However, the market appears to be pricing in future potential, as evidenced by the strong returns over various time frames. InvestingPro Data shows a remarkable 246.52% price total return over the past year, and a 35.5% return over the last three months. This performance aligns with the InvestingPro Tip highlighting significant returns over the last week and month.

Investors should be aware that Altimmune holds more cash than debt on its balance sheet, which could provide financial flexibility as it continues to develop pemvidutide and other pipeline candidates. This solid financial position is crucial for clinical-stage biopharmaceutical companies as they navigate the costly drug development process.

For those interested in a deeper analysis, InvestingPro offers 14 additional tips for Altimmune, providing a more comprehensive view of the company's financial health and market position.

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