Altimmune Announces Initiation of RESTORE Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol-Associated Liver Disease (ALD)
Altimmune (NASDAQ:ALT) has initiated the RESTORE Phase 2 trial evaluating pemvidutide for Alcohol-Associated Liver Disease (ALD). The randomized, placebo-controlled study will enroll 100 patients across 34 sites, with patients receiving either 2.4mg pemvidutide or placebo for 48 weeks.
The trial's primary endpoint focuses on changes in liver stiffness measurement at Week 24, with secondary endpoints including measurements at Week 48, Enhanced Liver Fibrosis score changes, and alterations in alcohol consumption and body weight. The study follows FDA clearance of the IND application in January 2025.
Pemvidutide, a novel GLP-1/glucagon dual receptor agonist, targets a significant medical need, as over 6 million Americans with Alcohol Use Disorder have progressed to ALD, a condition currently lacking approved treatments.
Altimmune (NASDAQ:ALT) ha avviato lo studio di Fase 2 RESTORE per valutare pemvidutide nella Malattia Epatica Associata all'Alcol (ALD). Lo studio randomizzato e controllato con placebo arruolerà 100 pazienti in 34 centri, che riceveranno 2,4 mg di pemvidutide o placebo per 48 settimane.
L'end point primario dello studio è rappresentato dalle variazioni nella misurazione della rigidità epatica alla settimana 24, mentre gli endpoint secondari includono le misurazioni alla settimana 48, le variazioni del punteggio di Fibrosi Epatica Avanzata, nonché i cambiamenti nel consumo di alcol e nel peso corporeo. Lo studio segue l'approvazione della domanda IND da parte della FDA nel gennaio 2025.
Pemvidutide, un nuovo agonista duale dei recettori GLP-1/glucagone, risponde a un bisogno medico rilevante, dato che oltre 6 milioni di americani con Disturbo da Uso di Alcol sono progrediti verso la ALD, una condizione attualmente priva di trattamenti approvati.
Altimmune (NASDAQ:ALT) ha iniciado el ensayo de Fase 2 RESTORE para evaluar pemvidutide en la Enfermedad Hepática Asociada al Alcohol (ALD). El estudio aleatorizado y controlado con placebo incluirá a 100 pacientes en 34 sitios, quienes recibirán 2,4 mg de pemvidutide o placebo durante 48 semanas.
El objetivo principal del ensayo se centra en los cambios en la medición de la rigidez hepática en la Semana 24, mientras que los objetivos secundarios incluyen mediciones en la Semana 48, cambios en la puntuación de Fibrosis Hepática Mejorada, y modificaciones en el consumo de alcohol y el peso corporal. El estudio sigue la aprobación de la solicitud IND por la FDA en enero de 2025.
Pemvidutide, un nuevo agonista dual de los receptores GLP-1/glucagón, aborda una necesidad médica significativa, ya que más de 6 millones de estadounidenses con Trastorno por Uso de Alcohol han progresado a ALD, una condición que actualmente no cuenta con tratamientos aprobados.
Altimmune (NASDAQ:ALT)는 알코올 관련 간질환(ALD)에 대한 펨비두타이드 평가를 위한 RESTORE 2상 시험을 시작했습니다. 무작위 배정, 위약 대조 연구로 34개 사이트에서 100명의 환자가 등록되며, 환자들은 48주 동안 2.4mg 펨비두타이드 또는 위약을 투여받습니다.
시험의 주요 평가 지표는 24주차 간 경직도 변화이며, 2차 평가 지표로는 48주차 측정값, 향상된 간 섬유증 점수 변화, 알코올 섭취량 및 체중 변화가 포함됩니다. 이 연구는 2025년 1월 FDA의 IND 승인 후 진행됩니다.
펨비두타이드는 새로운 GLP-1/글루카곤 이중 수용체 작용제로, 알코올 사용 장애를 가진 600만 명 이상의 미국인이 ALD로 진행된 상황에서 중요한 의료적 필요를 충족시키고 있습니다. 현재 ALD에 승인된 치료법은 없습니다.
Altimmune (NASDAQ:ALT) a lancé l'essai de Phase 2 RESTORE évaluant le pemvidutide pour la Maladie du Foie Associée à l'Alcool (ALD). Cette étude randomisée, contrôlée par placebo, inclura 100 patients répartis sur 34 sites, avec des patients recevant soit 2,4 mg de pemvidutide, soit un placebo pendant 48 semaines.
Le critère principal de l'essai porte sur les modifications de la mesure de la rigidité hépatique à la semaine 24, tandis que les critères secondaires comprennent les mesures à la semaine 48, les changements du score de Fibrose Hépatique Améliorée, ainsi que les modifications de la consommation d'alcool et du poids corporel. L'étude fait suite à l'autorisation de la FDA de la demande IND en janvier 2025.
Le pemvidutide, un nouvel agoniste double des récepteurs GLP-1/glucagon, répond à un besoin médical important, car plus de 6 millions d'Américains souffrant de troubles liés à l'alcool ont développé une ALD, une affection actuellement dépourvue de traitements approuvés.
Altimmune (NASDAQ:ALT) hat die RESTORE Phase-2-Studie zur Bewertung von Pemvidutid bei alkoholbedingter Lebererkrankung (ALD) gestartet. Die randomisierte, placebokontrollierte Studie wird 100 Patienten an 34 Standorten einschließen, die entweder 2,4 mg Pemvidutid oder Placebo über 48 Wochen erhalten.
Der primäre Endpunkt der Studie konzentriert sich auf Veränderungen der Lebersteifigkeitsmessung in Woche 24, sekundäre Endpunkte umfassen Messungen in Woche 48, Veränderungen des Enhanced Liver Fibrosis Scores sowie Änderungen im Alkoholkonsum und Körpergewicht. Die Studie folgt auf die FDA-Freigabe des IND-Antrags im Januar 2025.
Pemvidutid, ein neuartiger dualer GLP-1/Glukagon-Rezeptor-Agonist, adressiert einen bedeutenden medizinischen Bedarf, da über 6 Millionen Amerikaner mit Alkoholgebrauchsstörung eine ALD entwickelt haben, eine Erkrankung, für die derzeit keine zugelassenen Behandlungen existieren.
- FDA cleared the IND application for pemvidutide in ALD in January 2025
- Previous IMPACT Phase 2b MASH trial showed promising results with reductions in body weight, liver fat, and VCTE
- Addresses large market opportunity with 6 million Americans affected by ALD
- Trial led by prominent researcher Dr. Rohit Loomba from UC San Diego
- Long trial duration of 48 weeks before full results
- Relatively small trial size of 100 patients
- No currently approved treatments for ALD, indicating potential regulatory challenges
Insights
Altimmune's expansion of pemvidutide into ALD represents strategic pipeline growth targeting a large unmet medical need with encouraging preliminary data.
Altimmune's initiation of the RESTORE Phase 2 trial for pemvidutide in Alcohol-Associated Liver Disease (ALD) represents a significant expansion of their clinical development program. This GLP-1/glucagon dual receptor agonist is now being evaluated across multiple liver and metabolic conditions including MASH, AUD, ALD, and obesity.
The trial design is robust, with approximately 100 patients across 34 sites, using a 1:1 randomization to either 2.4mg pemvidutide or placebo for 48 weeks. The primary endpoint focuses on liver stiffness measurement (LSM) at 24 weeks, with additional key measurements at 48 weeks including Enhanced Liver Fibrosis (ELF) score, alcohol consumption, and body weight changes.
What makes this particularly notable is that ALD currently has no approved treatments despite affecting over 6 million Americans with Alcohol Use Disorder. The company is leveraging promising data from their IMPACT Phase 2b trial in MASH, where pemvidutide demonstrated statistically significant reductions in VCTE, liver fat, and markers of fibrosis and inflammation.
The company appears to be executing a strategic expansion of pemvidutide's potential applications, targeting indications with substantial unmet medical needs where the drug's dual mechanism of action – affecting both weight loss and liver-specific improvements – may provide unique therapeutic benefits. The involvement of Dr. Rohit Loomba, a recognized expert in liver disease, adds credibility to this clinical program.
GAITHERSBURG, Md., July 09, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has enrolled the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist in development for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), ALD and obesity.
RESTORE (NCT07009860) is a randomized, placebo-controlled trial enrolling approximately 100 patients across 34 sites, with Dr. Rohit Loomba, Professor of Medicine, Chief of the Division of Gastroenterology and Hepatology, and Director of the MASLD Research Center at the University of California, San Diego, serving as the principal investigator. Patients will be randomized 1:1 to 2.4mg pemvidutide or placebo for 48 weeks. The primary endpoint of the trial is the change from baseline in liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) at Week 24. Key secondary endpoints include the change from baseline in LSM by VCTE at Week 48, changes in Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48, and changes in alcohol consumption and body weight at the same time points. An investigational new drug (IND) application for pemvidutide in ALD was filed in December 2024 and cleared by FDA in January 2025.
“Of the 28 million Americans with AUD, over 6 million have progressed to ALD, a condition for which there are no approved treatments and few in development,” said Dr. Loomba. “Alcohol-related liver mortality is highest in patients with comorbid obesity, highlighting the urgent need for a liver-directed therapy that can also drive weight loss. The robust reductions in body weight, liver fat and VCTE and the low rates of adverse event discontinuation in the recently completed IMPACT Phase 2b MASH trial support my expectation for success, and I am honored to be a part of this important clinical trial.”
“We are excited to launch the RESTORE trial in ALD,” added Scott Harris, M.D., Chief Medical Officer of Altimmune. “We believe that the statistically significant reductions in VCTE, liver fat and markers of fibrosis and inflammation in the recent IMPACT trial at 24 weeks position pemvidutide for a positive efficacy readthrough in the RESTORE trial.”
About Pemvidutide
Pemvidutide is a novel, investigational, peptide-based 1:1 GLP-1/glucagon dual receptor agonist in development for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD) and obesity. 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 the ongoing IMPACT Phase 2b trial, at Week 24, once weekly pemvidutide demonstrated statistically significant MASH resolution without worsening of fibrosis, positive trends in liver fibrosis stage improvement without worsening of MASH, statistically significant reductions in non-invasive tests of fibrosis, weight loss, and liver fat content, and improvements in blood pressure. In a post-hoc AI-based analysis of the biopsies from the IMPACT trial, pemvidutide achieved a statistically significant reduction in liver fibrosis. In earlier trials, pemvidutide also demonstrated class-leading lean mass preservation and robust reductions in triglycerides and LDL cholesterol. Pemvidutide was well tolerated in the IMPACT trial, demonstrating potentially best-in-class tolerability among drugs in development for MASH with very low rates of discontinuation due to adverse events. The U.S. FDA granted Fast Track designation to pemvidutide for the treatment of MASH. The MOMENTUM Phase 2 obesity trial was completed in 2024 and the ongoing IMPACT Phase 2b MASH trial 48-week readout is expected in Q4 2025. In addition, RECLAIM, a Phase 2 trial in AUD and RESTORE, a Phase 2 trial in ALD, were initiated in May 2025 and July 2025, respectively.
About Altimmune
Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead program is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of MASH, AUD, ALD and obesity. 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 pemvidutide, an investigational product candidate, and other business and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the RESTORE trial and ongoing RECLAIM and IMPACT Trials, the timing of key milestones for the Company’s clinical assets, future plans or expectations for pemvidutide for the treatment of MASH, AUD, ALD and obesity, and the prospects for receiving regulatory approval or 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, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov.
Company Contact:
Greg Weaver
Chief Financial Officer
Phone: 240-654-1450
ir@altimmune.com
Investor Contact:
Lee Roth
Burns McClellan
Phone: 646-382-3403
lroth@burnsmc.com
Media Contact:
Jake Robison
Inizio Evoke Comms
Phone: 619-849-5383
jake.robison@inizioevoke.com
FAQ
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