Altimmune Presents Data from Phase 2 MOMENTUM Trial of Pemvidutide in Obesity during Oral Presentation at the American Diabetes Association’s 84th Scientific Sessions

Rhea-AI Summary

Altimmune presented data from its 48-week Phase 2 MOMENTUM trial of pemvidutide at the ADA’s 84th Scientific Sessions. The trial focused on pemvidutide, a GLP-1/glucagon dual receptor agonist for obesity treatment. Key findings show that 78.1% of weight loss was due to fat reduction, with only 21.9% from lean mass. The trial involved 391 subjects, achieving mean weight losses of 10.3%, 11.2%, 15.6%, and 2.2% for the 1.2 mg, 1.8 mg, 2.4 mg doses, and placebo, respectively. Additionally, pemvidutide improved serum lipids and blood pressure without notable cardiac events. These findings suggest that pemvidutide may offer a promising, long-term treatment for obesity.

Positive

• Pemvidutide achieved 78.1% fat loss and only 21.9% lean mass loss.
• Average weight loss of 15.6% at the highest dose of 2.4 mg.
• Improved serum lipids and blood pressure without notable cardiac issues.

Negative

• None.

Insights

Medical Research Analyst

The clinical trial results for pemvidutide present significant advancements in obesity treatment, showcasing an impressive 78.1% of weight loss attributable to fat and notably low lean mass loss of 21.9%. This can be important since lean mass, primarily muscle tissue, is vital for overall metabolic health and physical function. Most weight loss therapies lead to higher lean mass loss, so this data suggests pemvidutide could be a game-changer. The drug also improved other health markers like serum lipids and blood pressure without significant adverse effects, adding to its potential as a safe and effective obesity treatment.

Lean mass preservation is a critical factor distinguishing pemvidutide from other GLP-1 receptor agonists. Clinically, this could mean fewer side effects related to muscle loss and better long-term health outcomes for patients.

Market Research Analyst

From an investment perspective, Altimmune's positive Phase 2 results for pemvidutide could elevate the company's market position in the competitive obesity treatment space. The preservation of lean mass and significant fat loss differentiate pemvidutide from other obesity treatments, potentially leading to strong market demand. Investors should note the dual benefits of weight loss and improvement in cardiovascular health markers, which could open doors to broader patient demographics and higher market penetration.

The trial's success also positions Altimmune favorably for future partnerships or acquisitions with larger pharmaceutical companies, as the need for effective and safe obesity treatments remains high. Given the size of the obesity treatment market and the current trend towards combination therapies that address multiple facets of health, pemvidutide could capture substantial market share if it continues to show positive results in later-phase trials.

Financial Analyst

The trial results could have a short-term positive impact on Altimmune’s stock as investors react to the promising data. The 15.6% weight loss at the highest dose and significant lean mass preservation are particularly noteworthy, potentially driving the stock price up as the market anticipates further success in Phase 3 trials. However, it is vital for investors to consider the regulatory hurdles and the competitive landscape of obesity treatments, which includes established players like Novo Nordisk and Eli Lilly.

Long-term implications depend on successful Phase 3 trials and regulatory approval. If pemvidutide continues to demonstrate safety and efficacy, it could lead to substantial revenue growth for Altimmune. Furthermore, the drug’s ability to meet significant unmet needs in obesity treatment could justify a premium pricing strategy, enhancing profitability. Investors should, however, remain cautious of potential risks including regulatory delays or unforeseen adverse effects in larger patient populations.

Full analysis of body composition data showed class-leading lean mass preservation with 21.9% of 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 presented data from the 48-week Phase 2 MOMENTUM clinical trial of pemvidutide, its GLP-1/glucagon dual receptor agonist candidate, in obesity, including the results of a recently completed body composition analysis, at the American Diabetes Association’s (ADA) 84^th Scientific Sessions.

“We’re pleased with the data presented at ADA that highlight the impressive lean mass preservation achieved with pemvidutide, with only 21.9% of weight loss attributable to lean mass,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “The preservation of lean mass observed in this trial was better than reported historically with diet and exercise programs and greater than what has been publicly reported with other incretin weight loss drugs, where lean mass has accounted for as much as 40% of total weight loss. Preservation of lean mass, which is primarily muscle tissue, is believed to be important in 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 enrolled 391 subjects with obesity, or overweight with at least one co-morbidity and without diabetes. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and 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 the 1.2 mg, 1.8 mg, and 2.4 mg doses and placebo, respectively, with a near-linear continued weight loss observed on the 2.4 mg dose at the end of treatment. The full MRI-based body composition analysis included 50 subjects who received pemvidutide and showed that subjects in the pemvidutide groups had an average lean mass loss of 21.9% with 78.1% of weight loss attributable to fat. In addition, pemvidutide resulted in robust reductions in serum lipids and improvements in blood pressure without imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate.

“Obesity is a multifactorial disease, and patients will need a variety of treatment options that fit their specific needs and comorbidities,” said Louis Aronne, M.D., Director of the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes & Metabolism at Weill Cornell Medicine and Scientific Advisor of Altimmune. “These latest findings are particularly exciting given that pemvidutide has not only demonstrated significant weight loss but an impressive ability to preserve lean mass. With its favorable safety profile to-date and the potential to drive clinically meaningful improvements in other obesity-related conditions such as dyslipidemia and hypertension, pemvidutide could offer a highly promising, long-term treatment option for multiple segments of the obese patient population to safely and effectively manage body weight.”

About Pemvidutide

Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed 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 recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH 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 relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to 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 may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of 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 clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K and our other filings with the SEC, which are available at www.sec.gov.

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Company Contact:
Richard Eisenstadt
Chief Financial Officer
Phone: 240-654-1450
ir@altimmune.com

Investor Contacts:
Lee Roth
Burns McClellan
Phone: 646-382-3403
lroth@burnsmc.com

Julia Weilman
Burns McClellan
Phone: 646-732-4443
jweilman@burnsmc.com

Media Contact:
Danielle Cantey
Inizio Evoke, Biotech
Phone: 619-826-4657
Danielle.cantey@inizioevoke.com

FAQ

What are the main findings of Altimmune's Phase 2 MOMENTUM trial for pemvidutide in obesity?

Altimmune's Phase 2 MOMENTUM trial found that pemvidutide led to 78.1% of weight loss from fat and only 21.9% from lean mass, with significant weight loss and improved serum lipids and blood pressure.

How much weight loss was achieved in Altimmune's Phase 2 MOMENTUM trial?

Participants in the trial achieved mean weight losses of 10.3%, 11.2%, and 15.6% for the 1.2 mg, 1.8 mg, and 2.4 mg doses of pemvidutide, respectively.

What was the composition of weight loss in the pemvidutide trial presented by Altimmune?

In the trial, 21.9% of the weight loss was lean mass, and 78.1% was fat, highlighting significant fat reduction.

Did the Phase 2 MOMENTUM trial of pemvidutide show any improvement in health markers?

Yes, the trial showed robust reductions in serum lipids and improvements in blood pressure without notable cardiac events.

What safety profile did pemvidutide show in Altimmune's clinical trial?

Pemvidutide demonstrated a favorable safety profile with no imbalances in cardiac events, arrhythmias, or clinically meaningful increases in heart rate.