Phase II data being presented at the American Association for the Study of Liver Diseases annual meeting indicate drug development in the field of metabolic dysfunction-associated steatohepatitis (MASH) is making steady progress.
Top-line results from Altimmune Inc.’s phase IIb Impact study of pemvidutide in treating metabolic dysfunction-associated steatohepatitis showed the peptide-based GLP-1/glucagon dual receptor agonist hit one primary endpoint while not hitting statistical significance in another.
The obesity market is hot with Novo Nordisk A/S generating $6.3 billion in sales from its semaglutide-containing drugs, Ozempic, Saxenda, Rybelsus and Wegovy, in the first quarter of 2024 and Eli Lilly and Co. bringing in $2.3 billion for its tirzepatide-containing drugs, Zepbound and Mounjaro, in the same quarter. It appears unlikely the market will be a two-horse race for much longer though.
Altimmune Inc.’s peptide-based glucagon-like peptide-1/glucagon dual receptor agonist pemvidutide hiccupped in a phase I study earlier this year but has bounced back with top-line results from its phase II study in obesity. Results showed robust reductions in body mass index and serum lipids, along with improvements in blood pressure with no imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate. The data showed liver-fat loss similar to Novo Nordisk A/S’ GLP-1 drug Wegovy (semaglutide).
Glucagon-like peptide 1 receptor agonists have brought significant weight loss to patients, catching the attention of investors, but drug developers are continually seeking new therapies with different mechanisms to enhance the effects and improve the tolerability.
The ability of obesity medications to impact co-morbidities, reducing the symptoms and costs associated with down-the-road disease, has attracted significant attention throughout the biopharma industry.
Altimmune Inc. has come under scrutiny from investors after weight loss data from a phase Ib trial of its nonalcoholic fatty liver disease drug, pemvidutide, sent its shares on a roller coaster ride.
Shares in Altimmune Inc. and Angion Biomedica Corp. were sharply down after the companies announced trial disappointments from a nasal COVID-19 vaccine and two investigational therapies. Altimmune was worst hit, with shares (NASDAQ:ALT) dropping 38% to $9.80 June 30 after announcing its nasal COVID-19 vaccine did not produce enough immune response and axing an immunotherapy trial after encountering problems finding enough subjects.
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent. Shares of Equillium (NASDAQ:EQ) closed at $26.50, up $23.31, or 731%, after trading as high as $27.05. “We recognize we have to do a robust study,” said Bruce Steel, CEO of the La Jolla, Calif.-based firm. Talks with the FDA about design come next, but the clinical bid will “very likely include sites outside the U.S.,” where the need is high and where there is “somewhat less competition for patients,” he said.
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent.
