Weekly subcutaneous doses of pemvidutide resulted in robust reductions in cardio-inflammatory, hepato-inflammatory and atherosclerotic lipids
Findings support the potential benefit of pemvidutide on co-morbidities of metabolic dysfunction-associated steatohepatitis (MASH), including atherosclerosis, heart disease and metabolic syndrome
Pemvidutide is currently being evaluated in IMPACT, the Phase 2b trial in subjects with MASH; data readout expected in Q2 2025
GAITHERSBURG, Md., Nov. 15, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today presented new data from its 12-week Phase 1b trial of pemvidutide in metabolic dysfunction-associated steatotic liver disease (MASLD) at The Liver Meeting® of the American Association for the Study of Liver Diseases. The data showed reductions in multiple classes of inflammatory lipid species associated with adverse cardiovascular outcomes. Pemvidutide is a balanced GLP-1/glucagon dual receptor agonist in development for the treatment of MASH and obesity.
The new data were derived from an analysis of plasma samples from subjects who completed a randomized placebo-controlled Phase 1b trial of pemvidutide in subjects with overweight or obesity and MASLD. In the Phase 1b clinical trial, 94 subjects with obesity or overweight and liver fat content (LFC) ≥10% were dosed 1:1:1:1 to pemvidutide (1.2mg, 1.8mg and 2.4mg) or placebo administered once-weekly subcutaneously for 12 weeks. In this study, pemvidutide reduced LFC relative to baseline by up to 68.5% and decreased total cholesterol and triglycerides by up to 12.2% and 44.6%, respectively, after 12 weeks of treatment.
The goal of the study was to characterize changes in the lipid profile of patients before and after treatment with pemvidutide. In this study of 50 subjects, treatment with pemvidutide was shown to reduce plasma concentrations of atherogenic lipoproteins and lipotoxic lipid classes associated with MASH and implicated in cardiovascular and atherosclerotic disease. In particular, a rapid and significant reduction in small atherogenic LDL particles was observed in the 1.8 mg and 2.4 mg dose groups compared to placebo.
"Cardiovascular events, as opposed to liver-specific events, are the primary co-morbidities associated with MASH, and there is a growing unmet need for a therapy that can not only reduce the inflammation and fibrosis of MASH, but also address key drivers of the longer-term outcomes of the disease,” said Mazen Noureddin, M.D., MHS Director, Cedars-Sinai Medical Center Fatty Liver Program.
Dr. Vipin Garg, CEO of Altimmune added, "These data further underscore the potential for pemvidutide to be a differentiated MASH therapy that could address the principal co-morbidities associated with this growing disease. We look forward to sharing results from our ongoing biopsy-driven Phase 2b IMPACT trial of pemvidutide in MASH in the second quarter of 2025.”
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 with class-leading lean mass preservation, and 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.
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Any statements made in this press release related to the development or commercialization of product candidates and other business matters, including without limitation, trial results and data, 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.
Company Contact:
Vipin Garg
President and Chief Executive Officer
Phone: 240-654-1450
Media Contact:
Danielle Cantey
Inizio Evoke, Biotech
Phone: 619-826-4657
Investor Contact:
Lee Roth
Burns McClellan
Phone: 646-382-3403
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