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Altimmune Announces Positive Results From 12-week Phase 1 Clinical Trial of ALT-801 (Pemvidutide) in Overweight and Obese Volunteers
Mean weight loss of 10.3% achieved in subjects receiving 1.8 mg dosePemvidutide was well-tolerated without the need for dose titration No discontinuations due
About this update from Altimmune, Inc.
[{"type":"text","content":"Mean weight loss of 10.3% achieved in subjects receiving 1.8 mg dosePemvidutide was well-tolerated without the need for dose titration No discontinuations due to treatment-emergent adverse eventsNASH IND has cleared FDA review; 12-week NAFLD study to begin in the near futureAltimmune to host a conference call today at 8:30 am EST GAITHERSBURG, Md., Sept. 28, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced positive results from a 12-week, Phase 1 trial of pemvidutide (proposed INN, formerly known as ALT-801), an investigational glucagon-like peptide-1 (GLP-1)/glucagon dual receptor agonist. The Phase 1 study was a first-in-human, randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study in overweight and obese volunteers performed in Australia under a clinical trial application. Eligible participants included healthy, non-diabetic subjects with a minimum body mass index (BMI) of 25 kg/m2. Thirty-four (34) subjects in the MAD portion of the study were assigned to receive one of three subcutaneous doses of pemvidutide (1.2 mg, 1.8 mg and 2.4 mg) or placebo once weekly for 12 weeks without dose titration. Behavioral and caloric restrictive interventions were not employed. At 12 weeks, subjects receiving pemvidutide achieved mean weight losses of 4.9%, 10.3%, and 9.0% at the 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively, with the placebo group experiencing a mean weight loss of 1.6%. Weight loss occurred rapidly and consistently over 12-weeks. Side effects were mild to moderate, with no serious or severe treatment-emergent adverse events. Importantly, no discontinuations due to adverse events were reported. “The achievement of double-digit weight loss for subjects in the 1.8 mg arm with predominantly mild side effects reaffirms our enthusiasm for the potential of pemvidutide to be a transformational therapy for obesity and NASH,” said Vipin K. Garg, Ph.D., Chief Executive Officer of Altimmune. “We were able to reach this level of weight loss rapidly without dose titration, which is commonly used with other drugs in the GLP-1 class. With the recent clearance of our NASH IND, we are excited to begin the next phase of development to continue exploring this new therapy and the potential it has to positively impact those with obe...