Altimmune Announces FDA Clearance of Pemvidutide (ALT-801) IND for Obesity

Altimmune, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for obesity. Pemvidutide is an investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Altimmune expects to initiate the Phase 2 trial in obesity in the first quarter of 2022. The Company previously received IND clearance for pemvidutide in NASH and is currently enrolling subjects with nonalcoholic fatty liver disease (NAFLD) in a Phase 1b trial.

“This Phase 2 trial in obesity represents an important milestone toward developing a safe and effective treatment option for people with obesity,” said Vipin K. Garg, PhD, President and Chief Executive Officer of Altimmune. “Results from a recently completed Phase 1 study of pemvidutide in Australia showed that 12 weekly subcutaneous doses of pemvidutide at the 1.8 mg dose level resulted in an average weight loss of 10.3% in overweight and obese subjects. Importantly, there were no study discontinuations due to adverse events. We believe these results rank among the best in terms of the rate and magnitude of weight loss and tolerability among drugs in development for obesity.”

The Phase 2 clinical trial will enroll approximately 320 individuals with obesity or who are overweight with at least one obesity-related complication. Subjects will be randomized 1:1:1:1 to receive either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks. The primary endpoint of the study is the relative (percent) change in body weight at 48 weeks compared to baseline, with additional readouts including metabolic and lipid profiles, cardiovascular measures, and glucose homeostasis. An interim analysis is planned to assess changes in body weight after 24 weeks of treatment, with an expected readout in Q4 2022.

Pemvidutide (proposed INN, formerly known as ALT-801) is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and NASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. By combining GLP-1 and glucagon activity in a single peptide, pemvidutide has the potential to achieve weight loss comparable to bariatric surgery. Pemvidutide also has been shown to increase the breakdown of fat and its mobilization within the liver, which may have beneficial effects on insulin resistance, a common problem in people with obesity. Pemvidutide incorporates the EuPort domain, a proprietary technology that increases its serum half-life for weekly dosing while slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability. In a Phase 1 clinical study, pemvidutide demonstrated striking reductions in body weight, liver fat and serum lipids.

Altimmune is a clinical-stage biopharmaceutical company focused on the development of novel peptide-based therapeutics for the treatment of obesity and liver diseases. The company’s lead product candidate, pemvidutide (ALT-801), is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B. For more information, visit