Altimmune Axes Hepatitis B Program After Phase II Failure, Focuses on Obesity and MASH

2024-03-28

临床2期临床结果

Pictured: 3d illustration of hepatitis B viruses/iStock/Artur Plawgo Maryland-based Altimmune is eliminating its hepatitis B program after the company’s HepTcell candidate failed a Phase II trial, the biotech revealed Wednesday. According to Altimmune, results from the Phase II trial investigating the efficacy of HepTcell showed it to be “insufficient to warrant further advancement” and that further development has been halted. The candidate is an immunotherapeutic designed to drive CD4+ and CD8+ T-cell responses against all hepatitis B virus genotypes in patients. Phase I results, according to Altimmune, did manage to reach the primary endpoint of safety. With Altimmune’s pullback from hepatitis B, the focus is now on the red-hot obesity market as the biotech’s candidate, pemvidutide, is showing encouraging data. In Phase II results for the injectable drug, released in November 2023, the company reported mean weight loss of 15% based on a 2.4-mg dose at week 48. At the highest pemvidutide dose level, more than 30% of patients lost at least 20% of their weight. Pemvidutide is an investigational, peptide-based GLP-1/glucagon dual receptor agonist GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (MASH). On Thursday, Altimmune touted the recently completed MOMENTUM 48-week Phase II obesity trial for pemvidutide. “Our data show that 74.5% of weight loss was derived from adipose tissue and only 25.5% from lean mass, comparable to the effects historically associated with weight loss from diet and exercise programs,” Altimmune CEO Vipin Garg said in a statement. The “compelling” weight loss data shows that pemvidutide can “distinguish itself” from other therapies in the obesity space, according to Garg, who added that the company is anticipating results from its Phase IIb MASH trial sometime in the first quarter of 2025. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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