Altimmune Announces Publication of Clinical Study of Pemvidutide in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Journal of Hepatology
Altimmune (Nasdaq: ALT) has published data from a 12-week clinical trial of pemvidutide, a GLP-1/glucagon dual receptor agonist, in the Journal of Hepatology. The study focused on metabolic dysfunction-associated steatotic liver disease (MASLD). Key findings include:
- Up to 68.5% relative reduction in liver fat content (LFC)
- Up to 55.6% of subjects achieved LFC normalization
- Significant improvements in body weight and liver inflammation markers
- 94.4% of subjects achieved ≥30% relative reduction in LFC
- Well-tolerated with 2.9% adverse event discontinuations
Pemvidutide is currently in a Phase 2b IMPACT trial for metabolic dysfunction-associated steatohepatitis (MASH), with results expected in Q1 2025.
Altimmune (Nasdaq: ALT) ha pubblicato i dati di uno studio clinico di 12 settimane su pemvidutide, un agonista duale dei recettori GLP-1/glucagone, nella rivista Journal of Hepatology. Lo studio si è concentrato sulla malattia del fegato steatosica associata a disfunzione metabolica (MASLD). I risultati principali includono:
- Fino a un 68,5% di riduzione relativa del contenuto di grasso epatico (LFC)
- Fino a il 55,6% dei soggetti ha raggiunto la normalizzazione del LFC
- Miglioramenti significativi nei marker del peso corporeo e dell'infiammazione epatica
- Il 94,4% dei soggetti ha ottenuto una riduzione relativa del LFC ≥30%
- Ben tollerato con 2,9% di interruzioni per eventi avversi
Pemvidutide è attualmente in uno studio di Fase 2b IMPACT per la steatoepatite associata a disfunzione metabolica (MASH), con risultati attesi nel primo trimestre del 2025.
Altimmune (Nasdaq: ALT) ha publicado datos de un ensayo clínico de 12 semanas sobre pemvidutide, un agonista dual de los receptores GLP-1/glucagón, en la revista Journal of Hepatology. El estudio se centró en la enfermedad hepática esteatósica asociada a la disfunción metabólica (MASLD). Los hallazgos clave incluyen:
- Hasta un 68,5% de reducción relativa en el contenido de grasa en el hígado (LFC)
- Hasta el 55,6% de los sujetos alcanzaron la normalización del LFC
- Mejoras significativas en los marcadores de peso corporal e inflamación hepática
- El 94,4% de los sujetos lograron una reducción relativa del LFC ≥30%
- Bien tolerado con 2,9% de interrupciones por eventos adversos
Pemvidutide está actualmente en un ensayo de Fase 2b IMPACT para la esteatohepatitis asociada a disfunción metabólica (MASH), con resultados esperados para el primer trimestre de 2025.
Altimmune (Nasdaq: ALT)는 Journal of Hepatology에 GLP-1/글루카곤 이중 수용체 작용제인 페멧디타이드에 대한 12주 임상 시험 데이터를 발표했습니다. 이 연구는 대사 기능 장애와 관련된 지방간 질환(MASLD)에 중점을 두었습니다. 주요 발견 사항은 다음과 같습니다:
- 간 지방 함량(LFC)에서 최대 68.5% 상대 감소
- 55.6%의 피험자가 LFC 정상화에 도달
- 신체 중량 및 간 염증 마커에서 상당한 개선
- 94.4%의 피험자가 LFC에서 ≥30%의 상대 감소를 달성
- 2.9%의 부작용으로 인한 중단으로 잘 견딜 수 있음
현재 페멧디타이드는 대사 기능 장애와 관련된 지방간염(MASH)의 2b상 IMPACT 시험에 있으며, 2025년 1분기 결과가 예상됩니다.
Altimmune (Nasdaq: ALT) a publié des données d'un essai clinique de 12 semaines sur le pemvidutide, un agoniste dual des récepteurs GLP-1/glucagon, dans le Journal of Hepatology. L'étude s'est concentrée sur la maladie du foie gras associée à une dysfonction métabolique (MASLD). Les principaux résultats incluent :
- Jusqu'à une réduction relative de 68,5% du contenu en graisse hépatique (LFC)
- Jusqu'à 55,6 % des sujets ont atteint la normalisation du LFC
- Améliorations significatives des marqueurs de poids corporel et d'inflammation hépatique
- 94,4 % des sujets ont obtenu une réduction relative du LFC ≥30%
- Bien toléré avec 2,9% d'interruptions dues à des événements indésirables
Le pemvidutide est actuellement dans un essai de phase 2b IMPACT pour la stéatohépatite associée à une dysfonction métabolique (MASH), avec des résultats attendus au premier trimestre 2025.
Altimmune (Nasdaq: ALT) hat Daten aus einer 12-wöchigen klinischen Studie zu Pemvidutid, einem dualen GLP-1/Glukagon-Rezeptor-Agonisten, im Journal of Hepatology veröffentlicht. Die Studie konzentrierte sich auf die mit metabolischer Dysfunktion assoziierte Steatosis des Leberparenchyms (MASLD). Die wichtigsten Ergebnisse sind:
- Bis zu einer 68,5% relativen Reduktion des Leberfettgehalts (LFC)
- Bis zu 55,6% der Probanden erreichten eine Normalisierung des LFC
- Signifikante Verbesserungen bei Körpergewicht und Leberentzündungsmarkern
- 94,4% der Probanden erreichten eine relative Reduktion des LFC von ≥30%
- Gut verträglich mit 2,9% Abbruchrate aufgrund von Nebenwirkungen
Pemvidutid befindet sich derzeit in einer Phase 2b IMPACT-Studie zur metabolischen Dysfunktion und Steatohepatitis (MASH), mit Ergebnissen, die für das erste Quartal 2025 erwartet werden.
- Up to 68.5% relative reduction in liver fat content (LFC) compared to 4.4% in placebo group
- 94.4% of subjects receiving pemvidutide achieved ≥30% relative reduction in LFC vs 4.2% in placebo group
- Up to 55.6% of subjects achieved LFC normalization (≤5%) compared to 0% in placebo group
- Significant reductions in body weight and markers of MASH inflammatory activity observed
- Well-tolerated with only 2.9% rate of adverse event discontinuations and no severe or serious adverse events
- None.
As a Medical Research Analyst, I find the results of Altimmune's 12-week clinical trial for pemvidutide in MASLD patients highly promising. The up to 68.5% relative reduction in liver fat content (LFC) is remarkable, especially considering the short treatment duration. More impressively, up to 55.6% of subjects achieved LFC normalization, defined as LFC ≤5%. These results surpass those seen with other GLP-1 receptor agonists in similar populations.
The study's design, including the absence of diet or exercise interventions, strengthens the validity of the results. The high response rate, with up to 94.4% of subjects achieving ≥30% relative reduction in LFC, is particularly noteworthy as this level of reduction is associated with MASH resolution and fibrosis improvement.
The observed improvements in body weight and markers of MASH inflammatory activity (ALT and cT1 MRI) further support pemvidutide's potential efficacy. The drug's favorable safety profile, with only a 2.9% rate of adverse event discontinuations and no severe or serious adverse events, is encouraging for its potential long-term use.
However, it's important to note that this study's duration was relatively short at 12 weeks. The ongoing Phase 2b IMPACT trial, with results expected in Q1 2025, will provide important long-term data and insights into pemvidutide's effects on liver histology. This will be essential for fully evaluating its potential as a MASH treatment.
From a financial perspective, the publication of these positive clinical results in the Journal of Hepatology is a significant milestone for Altimmune (Nasdaq: ALT). The MASLD/MASH market represents a substantial opportunity, with an estimated 25% of adults globally affected by MASLD. Given the lack of approved treatments for MASH, a successful therapy could capture a significant market share.
Pemvidutide's impressive efficacy data, particularly the high rates of LFC reduction and normalization, positions it as a potential best-in-class treatment. This could translate into strong market adoption and revenue growth if approved. The drug's dual GLP-1/glucagon mechanism of action differentiates it from other incretin-based therapies, potentially providing a competitive advantage.
However, investors should note that pemvidutide is still in Phase 2b trials, with pivotal data not expected until Q1 2025. This timeline suggests that potential market entry and revenue generation are still several years away. Additionally, the competitive landscape in MASH treatment is evolving rapidly, with several other companies developing therapies.
Altimmune's financial position and ability to fund the ongoing IMPACT trial and potential Phase 3 studies will be important factors to monitor. The company's stock price may experience volatility as it approaches key clinical milestones. While these results are promising, prudent investors should consider the long development timeline and inherent risks in drug development when evaluating Altimmune as an investment opportunity.
Weekly subcutaneous doses of pemvidutide resulted in up to
LFC changes were accompanied by significant improvements in body weight and non-invasive markers of liver inflammation
Pemvidutide is currently being evaluated in the Phase 2b IMPACT trial in subjects with metabolic dysfunction-associated steatohepatitis (MASH), with data readout expected in Q1 2025
GAITHERSBURG, Md., July 25, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the data from its 12-week clinical trial of pemvidutide, an investigational GLP-1/glucagon dual receptor agonist, in metabolic dysfunction-associated steatotic liver disease (MASLD) has been published in the Journal of Hepatology.
“MASLD is estimated to affect
In the study, 94 subjects with obesity or overweight and LFC ≥
“We’re excited to publish the results of this study that demonstrate pemvidutide’s ability to significantly reduce liver fat, body weight, and hepatic inflammatory activity, supporting its potential as a treatment for MASH and obesity,” said Scott Harris, M.D., Chief Medical Officer of Altimmune. “Unlike other incretin-based therapies that lack glucagon activity, pemvidutide has a direct effect on hepatic fat metabolism, providing a mechanism for potentially more potent reductions in liver fat than that achieved through weight loss alone. Although not reported in this publication, the Phase 1 trial was extended for an additional 12 weeks, which resulted in up to
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.
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ir@altimmune.com
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