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Altimmune Presents Data on the Effect of Pemvidutide on Cardioinflammatory Lipids during Oral Presentation at American Diabetes Association’s 84th Annual Scientific Sessions

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Altimmune, a clinical-stage biopharmaceutical company, presented data on its GLP-1/glucagon dual receptor agonist candidate, pemvidutide, at the American Diabetes Association’s 84th Annual Scientific Sessions. Pemvidutide showed significant reductions in pro-inflammatory serum lipids, including total cholesterol, LDL-C, and triglycerides, by 28%, 26%, and 38% respectively. These lipid reductions were not linked to weight loss, implying a direct impact on lipid metabolism. The Phase 1 study involved 34 subjects receiving varying doses of pemvidutide or placebo for 12 weeks. Additionally, reductions in GlycA and GlycB, markers of systemic inflammation, and decreases in systolic and diastolic blood pressure were noted, suggesting a potential lowered cardiovascular disease risk.

Positive
  • Pemvidutide significantly reduced total cholesterol, LDL-C, and triglycerides by 28%, 26%, and 38% respectively.
  • Reductions in systemic inflammation markers GlycA and GlycB were observed.
  • Blood pressure reductions were noted across all dose groups, indicating potential pleiotropic effects.
Negative
  • The study was to a 12-week period and only involved 34 subjects.

The data presented on pemvidutide, a GLP-1/glucagon dual receptor agonist, showcases a promising advancement in the field of obesity and cardiovascular disease treatment. The ability to significantly reduce serum lipids such as total cholesterol, LDL-C and triglycerides independently of weight loss indicates a direct biochemical impact on lipid metabolism. This is notable because it suggests that pemvidutide might be targeting lipid profiles directly, a valuable trait for therapies aimed at reducing cardiovascular risk.

Furthermore, the reductions in small dense LDL-C and other specific lipid classes strongly associated with cardiovascular disease illustrate the compound's potential in addressing inflammation and plaque formation. Such results are critical, considering that dyslipidemia is prevalent in up to 70% of obese patients, thus offering a potentially comprehensive treatment approach.

For retail investors, it's important to realize that while these results are encouraging, they are derived from a Phase 1 study. The clinical significance and long-term safety profile of pemvidutide will need further validation in larger Phase 2 and 3 trials. Nevertheless, these findings place Altimmune in a favorable position within the biopharmaceutical landscape for obesity and metabolic disease treatments.

From a financial perspective, the successful presentation of clinical data at a renowned conference such as the ADA's Scientific Sessions is a strategic move for Altimmune. The significant reductions in cardiovascular risk markers highlight pemvidutide's potential as a valuable asset in their pipeline. This positions Altimmune as a contender in the lucrative obesity and metabolic disorder therapeutics market, which is projected to grow substantially over the coming years.

The data could attract further investment and partnerships, essential for advancing into later stages of clinical trials. Moreover, a successful candidate in this space could lead to substantial market adoption, considering the high prevalence of obesity and associated co-morbidities. This could potentially translate into millions in future revenue, provided the subsequent trial phases replicate these early positive results.

Investors should be cognizant of the inherent risks in drug development, such as the potential for adverse effects in larger population studies, regulatory hurdles and competition from other emerging therapies. However, these early signals of efficacy are promising and could enhance shareholder value if milestones are effectively met.

The data on pemvidutide’s impact on cardiovascular health is particularly compelling. Reductions in specific lipids that directly contribute to cardiovascular disease risk, independent of weight loss, point towards a multi-faceted approach in reducing heart disease risks. Notably, GlycA and GlycB reductions suggest a decrease in systemic inflammation, which is often linked with heart failure.

For cardiologists, a drug that can lower both systemic inflammation and specific lipid types while also reducing blood pressure is highly attractive. Such pleiotropic effects could greatly benefit patients with complex cardiovascular profiles, making pemvidutide a potentially transformative therapy in cardiometabolic care.

For investors, understanding this multidimensional benefit is key. It suggests that pemvidutide might not just be another weight-loss drug but a comprehensive treatment for enhancing overall cardiovascular health in patients with obesity, thus broadening its clinical application and market potential.

Pemvidutide elicited significant weight loss and decreases in pro-inflammatory serum lipids associated with atherogenesis and cardiovascular disease risk

GAITHERSBURG, Md., June 22, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today presented data on the effect of pemvidutide, its GLP-1/glucagon dual receptor agonist candidate in development for obesity and metabolic dysfunction-associated steatohepatitis (MASH), on cardioinflammatory lipids at the American Diabetes Association’s (ADA) 84th Scientific Sessions.

“Dyslipidemia is one of the most significant co-morbidities of obesity, impacting up to 70% of patients with obesity,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “These data add to the differentiated profile of pemvidutide and reinforce its potential to reduce inflammatory lipids associated with cardiovascular plaque formation and cardiovascular risk in patients with obesity.”

Dysregulated lipid profiles in obesity can cause systemic inflammation and elevate cardiovascular disease (CVD) risk. To better understand the potential impact of pemvidutide on lipoprotein and glycoprotein biomarkers of CVD inflammation, samples were analyzed from the 12-week, randomized placebo-controlled Phase 1 study of pemvidutide in subjects with overweight or obesity but not type 2 diabetes. In the study, 34 subjects were randomly assigned 1:1:1:1 to pemvidutide (1.2mg, 1.8mg and 2.4mg) or placebo administered once-weekly subcutaneously for 12 weeks. Lipidomic, lipoparticle and glycoprotein profiling was conducted using ultra-high performance liquid chromatography-mass spectrometry and proton nuclear magnetic resonance on plasma samples at baseline and after 12 weeks of treatment.

Serum lipids including total cholesterol, low density lipoprotein cholesterol (LDL-C), and triglycerides were reduced by 28%, 26% and 38% respectively. The reductions in each class of these lipids were not correlated with weight loss, suggesting that lipid effects were due to the direct impact of pemvidutide on lipid metabolism. A detailed analysis showed pemvidutide significantly reduced small dense LDL-C, short-chain diglycerides with higher degree of saturation, lysophosphatidylinositols, lysophosphatidylcholines and sphingolipids, all lipids with a strong association with CVD. Reductions in GlycA and GlycB, biomarkers of systemic inflammation that are known to correlate with heart failure, were also observed. In addition to the reductions in weight and serum lipids, treatment with pemvidutide resulted in reductions to systolic and diastolic blood pressure across all dose groups, suggesting that pemvidutide may have pleiotropic effects that may contribute to decreased CVD risk.

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 were the key findings of Altimmune's pemvidutide study presented at ADA 2024?

Pemvidutide significantly reduced pro-inflammatory serum lipids—total cholesterol by 28%, LDL-C by 26%, and triglycerides by 38%—and markers of systemic inflammation, GlycA and GlycB.

How did pemvidutide impact cardiovascular disease risk markers in Altimmune's study?

Pemvidutide reduced serum lipids and systemic inflammation markers, potentially decreasing cardiovascular disease risk.

What dosage forms of pemvidutide were used in Altimmune's Phase 1 study?

The Phase 1 study used pemvidutide doses of 1.2mg, 1.8mg, and 2.4mg administered once-weekly subcutaneously.

Was the lipid reduction in Altimmune's pemvidutide study linked to weight loss?

No, the lipid reductions observed were not correlated with weight loss, suggesting a direct impact of pemvidutide on lipid metabolism.

What is the significance of the reductions in GlycA and GlycB in Altimmune's study?

Reductions in GlycA and GlycB indicate a decrease in systemic inflammation, which correlates with lower heart failure risk.

What was the duration of Altimmune's Phase 1 study on pemvidutide?

The Phase 1 study on pemvidutide lasted for 12 weeks.

Altimmune, Inc.

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