Altimmune Presents New Data on the Effect of Pemvidutide on Inflammatory Lipids in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) at The Liver Meeting® 2024
Altimmune (Nasdaq: ALT) presented new data from its 12-week Phase 1b trial of pemvidutide in MASLD patients at The Liver Meeting®. The study demonstrated that weekly subcutaneous doses of pemvidutide significantly reduced inflammatory lipids and showed promising effects on cardiovascular health markers. In the trial of 94 subjects, pemvidutide reduced liver fat content by up to 68.5%, total cholesterol by 12.2%, and triglycerides by 44.6% after 12 weeks. The company is currently conducting the Phase 2b IMPACT trial in MASH patients, with results expected in Q2 2025.
Altimmune (Nasdaq: ALT) ha presentato nuovi dati dal suo studio di fase 1b della durata di 12 settimane su pemvidutide in pazienti con MASLD durante The Liver Meeting®. Lo studio ha dimostrato che dosi settimanali sottocutanee di pemvidutide hanno significativamente ridotto i lipidi infiammatori e mostrato effetti promettenti sui marcatori della salute cardiovascolare. Nello studio su 94 soggetti, pemvidutide ha ridotto il contenuto di grasso epatico fino al 68.5%, il colesterolo totale del 12.2%, e i trigliceridi del 44.6% dopo 12 settimane. L'azienda sta attualmente conducendo la fase 2b dello studio IMPACT su pazienti con MASH, con risultati attesi nel secondo trimestre del 2025.
Altimmune (Nasdaq: ALT) presentó nuevos datos de su estudio de fase 1b de 12 semanas sobre pemvidutide en pacientes con MASLD en The Liver Meeting®. El estudio demostró que las dosis subcutáneas semanales de pemvidutide redujeron significativamente los lípidos inflamatorios y mostraron efectos prometedores en los marcadores de salud cardiovascular. En el ensayo con 94 sujetos, pemvidutide redujo el contenido de grasa hepática hasta un 68.5%, el colesterol total en un 12.2%, y los triglicéridos en un 44.6% después de 12 semanas. La empresa está actualmente llevando a cabo el ensayo fase 2b IMPACT en pacientes con MASH, con resultados esperados en el segundo trimestre de 2025.
Altimmune (Nasdaq: ALT)는 The Liver Meeting®에서 MASLD 환자에 대한 pemvidutide의 12주간 1b상 임상시험의 새로운 데이터를 발표했습니다. 연구 결과, pemvidutide의 주간 피하 투여가 염증성 지질을 유의미하게 감소시키고 심혈관 건강 마커에 대해 유망한 효과를 보여주었습니다. 94명의 피험자를 대상으로 한 시험에서 pemvidutide는 12주 후 간 지방 함량을 최대 68.5%, 총 콜레스테롤을 12.2%, 그리고 중성지방을 44.6% 감소시켰습니다. 현재 이 회사는 MASH 환자를 대상으로 하는 2b상 IMPACT 임상시험을 진행 중이며, 결과는 2025년 2분기에 공개될 예정입니다.
Altimmune (Nasdaq: ALT) a présenté de nouvelles données de son essai de phase 1b de 12 semaines sur le pemvidutide chez des patients atteints de MASLD lors de The Liver Meeting®. L'étude a démontré que des doses sous-cutanées hebdomadaires de pemvidutide réduisaient significativement les lipides inflammatoires et montraient des effets prometteurs sur les marqueurs de santé cardiovasculaire. Dans l'essai portant sur 94 sujets, le pemvidutide a réduit la teneur en graisse hépatique jusqu'à 68.5%, le cholestérol total de 12.2%, et les triglycérides de 44.6% après 12 semaines. L'entreprise réalise actuellement l'essai IMPACT de phase 2b chez des patients MASH, avec des résultats attendus au deuxième trimestre de 2025.
Altimmune (Nasdaq: ALT) stellte auf The Liver Meeting® neue Daten aus seiner 12-wöchigen Phase-1b-Studie zu pemvidutide bei MASLD-Patienten vor. Die Studie zeigte, dass wöchentliche subkutane Dosen von pemvidutide inflammatorische Lipide signifikant reduzierten und vielversprechende Auswirkungen auf die kardiovaskulären Gesundheitsmarker zeigten. In der Studie mit 94 Probanden reduzierte pemvidutide den Leberfettgehalt um bis zu 68.5%, das Gesamtkolesterin um 12.2%, und die Triglyceride um 44.6% nach 12 Wochen. Das Unternehmen führt derzeit die Phase-2b-IMPACT-Studie bei MASH-Patienten durch, mit Ergebnissen, die im 2. Quartal 2025 erwartet werden.
- Significant reduction in liver fat content (up to 68.5%)
- Notable decrease in triglycerides (44.6%) and total cholesterol (12.2%)
- Demonstrated reduction in atherogenic lipoproteins and lipotoxic lipid classes
- Positive results in treating both liver condition and cardiovascular risk factors
- Phase 2b trial results not expected until Q2 2025
- Current data to 12-week trial period
Insights
The new data from Altimmune's Phase 1b trial reveals significant therapeutic potential for pemvidutide in treating MASLD/MASH. The drug demonstrated impressive reductions in liver fat content (up to
These results are particularly compelling because they address both liver disease progression and cardiovascular complications - the leading cause of mortality in MASH patients. The dual GLP-1/glucagon mechanism appears to offer broader metabolic benefits compared to pure GLP-1 agonists. With the Phase 2b IMPACT trial results expected in Q2 2025, positive outcomes could position pemvidutide as a potential first-line treatment for MASH, addressing both hepatic and cardiovascular manifestations of the disease.
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) ≥
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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Forward-Looking Statement
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
ir@altimmune.com
Media Contact:
Danielle Cantey
Inizio Evoke, Biotech
Phone: 619-826-4657
Danielle.cantey@inizioevoke.com
Investor Contact:
Lee Roth
Burns McClellan
Phone: 646-382-3403
lroth@burnsmc.com
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FAQ
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