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altimmune Altimmune Announces Positive Results From 12 - week Phase 1 Clinical Trial of ALT - 801 ( Pemvidutide ) in Overweight and Obese Volunteers September 28 , 2021 • Mean weight loss of 10.3 % achieved in subjects receiving 1.8 mg dose • Pemvidutide was well - tolerated without the need for dose titration • No discontinuations due to treatment - emergent adverse events • NASH IND has cleared FDA review ; 12 - week NAFLD study to begin in the near future • Altimmune 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 obesity and metabolic disorders . " " The rapid weight loss and response to pemvidutide across patients and dose groups highlight the therapeutic advantage conferred by balanced agonism at the GLP - 1 and glucagon receptors , " said Scott Harris , M.D. , Chief Medical Officer of Altimmune . " Given that these weight loss data were obtained without diet or behavioral modifications , we are excited to see weight loss reach its full potential during the planned 48 - week Phase 2 obesity trial next year . " Summary of 12 - week MAD weight loss findings Treatment 1.2mg 1.8mg ( n = 7 ) ( n = 9 ) 2.4mg ( n = 11 ) Pooled Placebo ( n = 7 ) Baseline demographics Age , years mean 27.7 32.0 31.4 35.3 BMI ( kg / m² ) mean 30.0 30.1 31.8 31.0 Results Weight loss ( kg ) Weight loss ( % ) mean -4.7 -8.8 -8.4 -1.5 mean -4.9 % -10.3 % ** -9.0 % * -1.6 % * p < .01 , ** p < .005 , compared to placebo The 1.8 mg dose cohort experienced the highest weight loss , with 100 % of subjects losing at least 5 % of body weight and 55 % of subjects losing at least 10 % of their body weight . The amounts of weight loss at the 1.8 and 2.4 mg doses were essentially the same given the sample size and overlapping confidence intervals . No correlation was found between the magnitude of weight loss and either age or baseline BMI . Favorable trends were observed in secondary measures , including reductions in systolic and diastolic blood pressure , serum lipids , and HOMA - IR ( a measure of insulin resistance ) . In addition , a rise in ketone bodies was observed , consistent with the effects of glucagon on fat metabolism . Summary of 12 - week MAD safety findings Treatment Characteristic 1.2mg ( n = 7 ) 1.8mg ( n = 9 ) 2.4mg ( n = 11 ) Pooled Placebo ( n = 7 ) Discontinuations due to adverse events ( n ) Early withdrawal ( n ) 0 0 0 0 1 0 2 2