Altimmune Inc. (NASDAQ: ALT) has released encouraging results from the twelve-week first phase study of pemvidutide. Pemvidutide is an experimental glucagon-like peptide-1 glucagon double receptor agonist.
Altimmune studied pemvidutide in obese and overweight subjects
The first phase study in obese and overweight volunteers was a first-in-human, placebo-controlled, randomized, multiple ascending dosages (MAD) and single ascending dose (SAD) trial conducted in Australia as per the clinical study application. Healthy, non-diabetic individuals with a minimum BMI of 25 kg/m2 were eligible to participate. In the MAD part of the trial, 34 patients were randomized to receive one of the three subcutaneous pemvidutide dosages (1.2 mg, 1.8 mg, or 2.4 mg) or a placebo once per week for 12 weeks without dose titration. There were no calorie-restrictive or behavioral therapies used.
No adverse events were observed in treatment arms.
After 12 weeks, patients on pemvidutide lost 4.9%, 10.3%, and 9.0% of their body weight, respectively, for the 1.2 mg, 1.8 mg, and 2.4 mg doses. On the other hand, the placebo group lost 1.6% of their body weight. Notably, over the course of the 12 weeks, weight loss was rapid and constant. In addition, there were severe or no major treatment-emergent adverse events reported with mild to moderate side effects observed. Importantly, no withdrawals were observed due to the adverse impacts.
CEO Vipin Garg said, “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. 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 obesity and metabolic disorders.”