Altimmune Inc. (ALT) said that mean weight loss of 10.3% achieved in subjects receiving 1.8 mg dose of pemvidutide, as per phase 1 clinical trial of pemvidutide or ALT-801 in overweight and obese subjects.
In Tuesday pre-market trade, ALT was trading at $12.29 down $2.90 or 19.09%.
Thirty-four (34) subjects in the multiple ascending dose or 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.
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. 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.
Given that weight loss data were obtained without diet or behavioral modifications, the company expects to see weight loss reach its full potential during the planned 48-week Phase 2 obesity trial next year.
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