Altimmune Announces Initiation of RECLAIM Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol Use Disorder (AUD)
Altimmune (NASDAQ: ALT) has initiated the RECLAIM Phase 2 trial for pemvidutide in Alcohol Use Disorder (AUD). The trial will evaluate the drug's efficacy and safety across approximately 15 U.S. sites, enrolling about 100 subjects in a 1:1 randomization to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks.
The trial's primary endpoint focuses on changes in alcohol consumption, measured by heavy drinking days per week at Week 24. Pemvidutide, a novel GLP-1/glucagon dual receptor agonist, is also being studied for MASH, obesity, and alcohol liver disease (ALD). The company expects topline data from the IMPACT Phase 2b trial in MASH in Q2 2025 and plans to initiate a Phase 2 trial in ALD in Q3 2025.
The study addresses a significant market opportunity, with over 28 million individuals in the U.S. affected by AUD, where less than 10% receive treatment and 2% or less use approved medications.
Altimmune (NASDAQ: ALT) ha avviato lo studio di Fase 2 RECLAIM per pemvidutide nel trattamento del Disturbo da Uso di Alcol (AUD). Lo studio valuterà l'efficacia e la sicurezza del farmaco in circa 15 centri negli Stati Uniti, arruolando circa 100 soggetti con una randomizzazione 1:1 per ricevere settimanalmente 2,4 mg di pemvidutide o placebo per 24 settimane.
L'endpoint primario dello studio si concentra sulle variazioni nel consumo di alcol, misurato in base ai giorni di consumo eccessivo di alcol a settimana alla 24ª settimana. Il pemvidutide, un nuovo agonista duale dei recettori GLP-1/glucagone, è inoltre in fase di studio per MASH, obesità e malattia epatica alcolica (ALD). L'azienda prevede di ottenere i dati principali dallo studio IMPACT di Fase 2b in MASH nel secondo trimestre del 2025 e pianifica di avviare uno studio di Fase 2 in ALD nel terzo trimestre del 2025.
Lo studio risponde a una significativa opportunità di mercato, con oltre 28 milioni di persone negli Stati Uniti affette da AUD, di cui meno del 10% riceve trattamento e solo il 2% o meno utilizza farmaci approvati.
Altimmune (NASDAQ: ALT) ha iniciado el ensayo de Fase 2 RECLAIM para pemvidutide en el Trastorno por Consumo de Alcohol (AUD). El ensayo evaluará la eficacia y seguridad del medicamento en aproximadamente 15 sitios en EE. UU., inscribiendo alrededor de 100 sujetos con una aleatorización 1:1 para recibir semanalmente 2.4 mg de pemvidutide o placebo durante 24 semanas.
El objetivo principal del ensayo se centra en los cambios en el consumo de alcohol, medido por los días de consumo excesivo por semana en la Semana 24. Pemvidutide, un novedoso agonista dual de los receptores GLP-1/glucagón, también se está estudiando para MASH, obesidad y enfermedad hepática alcohólica (ALD). La compañía espera datos principales del ensayo IMPACT de Fase 2b en MASH en el segundo trimestre de 2025 y planea iniciar un ensayo de Fase 2 en ALD en el tercer trimestre de 2025.
El estudio aborda una oportunidad de mercado significativa, con más de 28 millones de personas en EE. UU. afectadas por AUD, donde menos del 10% recibe tratamiento y un 2% o menos utiliza medicamentos aprobados.
Altimmune (NASDAQ: ALT)가 알코올 사용 장애(AUD)에 대한 펨비두타이드의 RECLAIM 2상 시험을 시작했습니다. 이 시험은 미국 내 약 15개 기관에서 진행되며, 약 100명의 참가자를 1:1 무작위 배정하여 24주 동안 매주 2.4mg 펨비두타이드 또는 위약을 투여하여 약물의 효능과 안전성을 평가합니다.
시험의 주요 평가 지표는 24주 차에 측정한 주당 과음 일수 변화를 중심으로 합니다. 펨비두타이드는 새로운 GLP-1/글루카곤 이중 수용체 작용제로, MASH, 비만 및 알코올성 간질환(ALD) 치료제로도 연구 중입니다. 회사는 2025년 2분기에 MASH 대상 IMPACT 2b상 시험의 주요 데이터를 기대하며, 2025년 3분기에 ALD 대상 2상 시험을 시작할 계획입니다.
이 연구는 미국 내 2,800만 명 이상의 AUD 환자라는 큰 시장 기회를 겨냥하고 있으며, 이 중 10% 미만만 치료를 받고 있고 승인된 약물 사용률은 2% 이하에 불과합니다.
Altimmune (NASDAQ : ALT) a lancé l'essai de Phase 2 RECLAIM pour le pemvidutide dans le trouble lié à l'usage d'alcool (AUD). L'essai évaluera l'efficacité et la sécurité du médicament dans environ 15 sites aux États-Unis, en recrutant environ 100 sujets randomisés 1:1 pour recevoir soit 2,4 mg de pemvidutide, soit un placebo chaque semaine pendant 24 semaines.
Le critère principal de l'essai porte sur les changements dans la consommation d'alcool, mesurés par le nombre de jours de consommation excessive par semaine à la semaine 24. Le pemvidutide, un nouvel agoniste double des récepteurs GLP-1/glucagon, est également étudié pour la MASH, l'obésité et la maladie hépatique alcoolique (ALD). La société prévoit des données principales de l'essai IMPACT de Phase 2b en MASH au deuxième trimestre 2025 et envisage de lancer un essai de Phase 2 en ALD au troisième trimestre 2025.
Cette étude répond à une opportunité de marché importante, avec plus de 28 millions de personnes aux États-Unis touchées par l'AUD, dont moins de 10 % reçoivent un traitement et 2 % ou moins utilisent des médicaments approuvés.
Altimmune (NASDAQ: ALT) hat die RECLAIM Phase-2-Studie für Pemvidutid bei Alkoholgebrauchsstörung (AUD) gestartet. Die Studie wird die Wirksamkeit und Sicherheit des Medikaments an etwa 15 Standorten in den USA untersuchen und etwa 100 Probanden im Verhältnis 1:1 randomisiert entweder 2,4 mg Pemvidutid oder Placebo wöchentlich über 24 Wochen verabreichen.
Der primäre Endpunkt der Studie konzentriert sich auf Veränderungen im Alkoholkonsum, gemessen an den Tagen mit starkem Alkoholkonsum pro Woche in Woche 24. Pemvidutid, ein neuartiger dualer GLP-1/Glucagon-Rezeptor-Agonist, wird auch für MASH, Adipositas und alkoholbedingte Lebererkrankungen (ALD) untersucht. Das Unternehmen erwartet Topline-Daten aus der IMPACT Phase 2b-Studie bei MASH im zweiten Quartal 2025 und plant den Start einer Phase-2-Studie bei ALD im dritten Quartal 2025.
Die Studie adressiert eine bedeutende Marktchance mit über 28 Millionen Betroffenen in den USA mit AUD, von denen weniger als 10 % behandelt werden und 2 % oder weniger zugelassene Medikamente verwenden.
- Preclinical data showed >80% reduction in alcohol preference after pemvidutide treatment
- Large market opportunity with 28 million individuals in U.S. having AUD
- Multiple potential indications for pemvidutide (MASH, obesity, AUD, ALD)
- FDA cleared the IND application for pemvidutide in AUD in January 2025
- Early-stage clinical trial (Phase 2) with no efficacy data yet
- Will face competition from existing GLP-1 medications
- Small trial size of only 100 subjects
Insights
Altimmune's initiation of Phase 2 RECLAIM trial for pemvidutide in AUD represents significant expansion into a large, underserved market with promising preclinical data.
Altimmune has enrolled the first subject in their RECLAIM Phase 2 trial evaluating pemvidutide in Alcohol Use Disorder (AUD), marking an important milestone in their clinical development pipeline. This trial will assess the GLP-1/glucagon dual receptor agonist in approximately 100 subjects over 24 weeks at roughly 15 US sites, with subjects randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly.
The trial design is scientifically sound, focusing on concrete endpoints: primary assessment will measure change from baseline in average heavy drinking days per week, with secondary endpoints including the proportion of subjects achieving reduced WHO risk drinking levels and changes in phosphatidylethanol (PEth), a biomarker of alcohol intake. The trial received FDA IND clearance in January 2025, demonstrating regulatory acceptance of the scientific approach.
What's particularly notable is how Altimmune is strategically expanding pemvidutide's potential applications. The company is simultaneously conducting the IMPACT Phase 2b trial in MASH (metabolic dysfunction-associated steatohepatitis) with topline data expected in Q2 2025, and plans to initiate a Phase 2 trial in alcohol liver disease (ALD) in Q3 2025. This multi-indication strategy maximizes pemvidutide's commercial potential by targeting related conditions with overlapping pathophysiology.
The preclinical data is particularly compelling, showing 80% reduction in alcohol preference in animal models. This builds on growing evidence that GLP-1 agents may reduce cravings for both alcohol and food, addressing multiple aspects of these metabolic and addiction disorders simultaneously. With 28 million Americans suffering from AUD and less than 10% receiving treatment, pemvidutide could address a significant unmet medical need in a woefully underserved market.
GAITHERSBURG, Md., May 19, 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 subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol Use Disorder (AUD). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD and alcohol liver disease (ALD). IMPACT, a Phase 2b trial of pemvidutide in MASH, is expected to read out topline data in the second quarter of 2025, and a Phase 2 trial of pemvidutide in ALD is expected to initiate enrollment in the third quarter of 2025.
RECLAIM is a randomized, placebo-controlled trial being conducted at approximately 15 sites in the United States, with Dr. Henry Kranzler, Karl E. Rickels Professor of Psychiatry and Director, Center for Studies of Addiction at the University of Pennsylvania Perelman School of Medicine, serving as the Principal Investigator. The trial is expected to enroll approximately 100 subjects randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks. The primary endpoint of the trial is a change in alcohol consumption, assessed as the change from baseline in the average number of heavy drinking days per week at Week 24, with the key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization (WHO) risk drinking level and the absolute change from baseline in average levels of phosphatidylethanol (PEth), a serum biomarker of alcohol intake. An investigational new drug (IND) application for pemvidutide in AUD was filed in December 2024 and was cleared by FDA in January 2025.
“Over 28 million individuals in the U.S. alone have AUD, and the lack of effective treatments has resulted in one of the largest known treatment gaps in this country,” said Dr. Kranzler. “It has been estimated that less than
“There are compelling data that GLP-1 agents may reduce the craving for alcohol in addition to reducing food consumption,” said Scott Harris, M.D., Chief Medical Officer of Altimmune. “In a preclinical hamster model of free-choice alcohol intake, pemvidutide demonstrated a greater than
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, obesity, Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD). For more information, please visit www.altimmune.com.
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ir@altimmune.com
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1 SAMHSA 2023 NSDUH Survey
2 Altimmune R&D Day Presentation, slide #47
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FAQ
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