Comprehensive analysis of body composition data showed best-in-class preservation of lean mass with 21.9% weight loss attributable to lean mass and 78.1% attributable to fat.
GAITHERSBURG, Md., June 23, 2024 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today reported data from the long-term Phase 2 MOMENTUM clinical trial. of 48 weeks on pemvidutide, its BPL -1/glucagon dual receptor agonist candidate, in obesity, including the results of a recently performed body composition analysis, at the American Diabetes Association (ADA) 84th Scientific sessions.
“We are pleased with the data presented at the ADA that highlight the impressive preservation of lean mass achieved with pemvidutide, with only 21.9% of weight loss attributable to lean mass,” said Vipin K . Garg, Ph.D., President and CEO. Altimmune officer. “The preservation of lean mass observed in this trial was better than that reported historically with diet and exercise programs and greater than what has been publicly reported with other incretin-based weight loss medications, where lean mass accounted for up to 40% of total weight loss. . Preserving lean mass, which is primarily muscle tissue, is considered important for maintaining healthy weight loss and physical function. We believe that the level of muscle preservation observed in the phase 2 trial further adds to the differentiation of pemvidutide in the treatment of obesity.
The trial included 391 subjects suffering from obesity or overweight with at least one comorbidity and without diabetes. Subjects were randomized 1:1:1:1 to receive pemvidutide 1.2 mg, 1.8 mg, 2.4 mg, or placebo administered weekly for 48 weeks in combination with diet and medication. ‘exercise. A subgroup of subjects was evaluated in a body composition analysis.
At week 48, subjects receiving pemvidutide achieved mean weight losses of 10.3%, 11.2%, 15.6% and 2.2% at doses of 1.2 mg, 1.8 mg and 2.4 mg and placebo, respectively, with continued quasi-linear weight loss observed at the 2.4 mg dose at the end of treatment. The comprehensive MRI-based body composition analysis included 50 subjects who received pemvidutide and showed that subjects in the pemvidutide groups had a mean lean mass loss of 21.9%, including 78.1%. weight loss attributable to fat. Additionally, pemvidutide produced large reductions in serum lipids and improvements in blood pressure without imbalance of cardiac events, arrhythmias, or clinically significant increases in heart rate.
“Obesity is a multifactorial disease and patients will need a variety of treatment options tailored to their specific needs and comorbidities,” said Louis Aronne, MD, director of the Comprehensive Weight Control Center, Division of Obesity. endocrinology, diabetes and metabolism at Weill Cornell Medicine. and scientific advisor to Altimmune. “These latest findings are particularly exciting given that pemvidutide not only demonstrated significant weight loss, but also an impressive ability to preserve lean mass. With its favorable safety profile to date and the potential for clinically meaningful improvement in other obesity-related conditions such as dyslipidemia and hypertension, pemvidutide could offer a very promising long-term treatment option. for several segments of the obese patient population to treat safely. and effectively manage body weight.
About pemvidudide
Pemvidutide is a novel investigational peptide-based GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and MASH. Activation of GLP-1 and glucagon receptors is thought to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also known to have direct effects on hepatic fat metabolism, which would result in a rapid reduction in hepatic fat and serum lipid levels. So far, in clinical trials, once-weekly pemvidutide has demonstrated convincing weight loss, strong reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure. The US FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the Phase 2 MOMENTUM obesity trial and is being studied in the ongoing Phase 2b MASH IMPACT trial.
About Altimmune
Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative, next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com.
Forward-looking statement
Any statements made in this press release regarding future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters, including, without limitation, timing milestones of our clinical assets and the prospects of the usefulness, regulatory approval, marketing or sale of any product or drug candidate are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Additionally, when used in this press release, the words “may”, “could”, “should”, “anticipate”, “believe”, “estimate”, “expect”, “intend” , “plan”, “predict” and similar expressions and variations thereof, as Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Important factors that could cause actual results to differ materially from the results discussed in the forward-looking statements or from historical experience include risks and uncertainties, including risks related to delays in regulatory review, interruptions in manufacturing and supply chain, access to clinical sites, registration. , adverse effects on health systems and disruption to the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture equipment for clinical trials on schedule; and the success of future product advancements, including the success of future clinical trials. Further information about the factors and risks that could affect the Company’s business, financial condition and results of operations is contained in the Company’s filings with the United States Securities and Exchange Commission, including included under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K and our other filings with the SEC, available at www.sec.gov.
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Company contact:
Richard Eisenstadt
Financial director
Telephone: 240-654-1450
ir@altimmune.com
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Lee Roth
Burns McClellan
Telephone: 646-382-3403
lroth@burnsmc.com
Julia Weilman
Burns McClellan
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jweilman@burnsmc.com
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Early Evoke, Biotechnology
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