Altimmune Announces FDA Fast Track Designation for Pemvidutide in Alcohol Use Disorder (AUD)
Altimmune (NASDAQ:ALT) has received FDA Fast Track designation for pemvidutide in treating Alcohol Use Disorder (AUD). The company is currently conducting RECLAIM, a Phase 2 trial enrolling approximately 100 patients to evaluate pemvidutide's safety and efficacy in AUD treatment.
The trial, which began in May 2025, will randomize patients 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks. The study's primary endpoint focuses on reducing heavy drinking days, with secondary endpoints including WHO risk drinking level reduction and changes in alcohol intake biomarkers.
AUD affects over 28 million adults in the U.S., with only 2% receiving medication treatment, highlighting a significant unmet medical need. Pemvidutide's potential effectiveness is supported by preclinical studies showing significant reduction in alcohol intake.
Altimmune (NASDAQ:ALT) ha ottenuto la designazione Fast Track dalla FDA per pemvidutide nel trattamento del Disturbo da Uso di Alcol (AUD). L’azienda sta conducendo lo studio di Fase 2 RECLAIM, che arruolerà circa 100 pazienti per valutare la sicurezza e l’efficacia di pemvidutide nell’AUD.
Lo studio, iniziato a maggio 2025, randomizzerà i partecipanti 1:1 per ricevere 2,4 mg di pemvidutide o un placebo settimanalmente per 24 settimane. L’endpoint primario è la riduzione dei giorni di consumo intenso di alcol; gli endpoint secondari includono la riduzione del livello di rischio secondo l’OMS e le variazioni dei biomarcatori legati all’assunzione di alcol.
L’AUD colpisce oltre 28 milioni di adulti negli USA, ma solo il 2% riceve una terapia farmacologica, evidenziando un importante bisogno medico insoddisfatto. L’efficacia potenziale di pemvidutide è supportata da studi preclinici che mostrano una significativa riduzione dell’assunzione di alcol.
Altimmune (NASDAQ:ALT) ha recibido la designación Fast Track de la FDA para pemvidutide en el tratamiento del Trastorno por Consumo de Alcohol (AUD). La compañía está llevando a cabo el ensayo de Fase 2 RECLAIM, que reclutará aproximadamente a 100 pacientes para evaluar la seguridad y eficacia de pemvidutide en AUD.
El ensayo, iniciado en mayo de 2025, aleatorizará a los pacientes 1:1 para recibir 2,4 mg de pemvidutide o placebo semanalmente durante 24 semanas. El objetivo primario del estudio es la reducción de los días de consumo excesivo; los objetivos secundarios incluyen la reducción del nivel de riesgo según la OMS y cambios en biomarcadores relacionados con la ingesta de alcohol.
El AUD afecta a más de 28 millones de adultos en EE. UU., y solo el 2% recibe tratamiento farmacológico, lo que evidencia una importante necesidad médica no cubierta. La eficacia potencial de pemvidutide está respaldada por estudios preclínicos que muestran una reducción significativa en la ingesta de alcohol.
Altimmune (NASDAQ:ALT)는 알코올 사용 장애(AUD) 치료를 위한 펨비두타이드에 대해 FDA 패스트트랙 지정을 받았습니다. 회사는 현재 펨비두타이드의 AUD 치료에서의 안전성과 유효성을 평가하기 위해 약 100명을 대상으로 하는 2상 임상시험 RECLAIM을 진행 중입니다.
2025년 5월에 시작된 이 시험은 환자를 1:1로 무작위 배정하여 주당 2.4mg 펨비두타이드 또는 위약을 24주간 투여합니다. 주요 평가 변수는 폭음일수 감소에 중점을 두며, 2차 평가 변수로 WHO 위험 음주 수준 감소 및 알코올 섭취 관련 바이오마커 변화가 포함됩니다.
AUD는 미국에서 2800만 명 이상의 성인에게 영향을 미치지만 약물 치료를 받는 비율은 2%에 불과해 큰 미충족 의료 수요가 존재합니다. 펨비두타이드의 잠재적 효과는 알코올 섭취를 유의미하게 감소시켰다는 전임상 연구 결과로 뒷받침됩니다.
Altimmune (NASDAQ:ALT) a obtenu la désignation Fast Track de la FDA pour le pemvidutide dans le traitement du trouble lié à l’usage d’alcool (AUD). La société mène actuellement l’essai de phase 2 RECLAIM, qui prévoit d’inclure environ 100 patients afin d’évaluer la sécurité et l’efficacité du pemvidutide dans l’AUD.
L’essai, lancé en mai 2025, randomisera les patients 1:1 pour recevoir 2,4 mg de pemvidutide ou un placebo chaque semaine pendant 24 semaines. Le critère principal porte sur la réduction des jours de consommation excessive d’alcool ; les critères secondaires incluent la diminution du niveau de risque OMS et les modifications des biomarqueurs liés à la consommation d’alcool.
L’AUD touche plus de 28 millions d’adultes aux États-Unis, et seulement 2 % d’entre eux reçoivent un traitement médicamenteux, mettant en évidence un besoin médical majeur non satisfait. L’efficacité potentielle du pemvidutide est étayée par des études précliniques montrant une réduction significative de la consommation d’alcool.
Altimmune (NASDAQ:ALT) hat für Pemvidutide die FDA Fast Track-Zulassung zur Behandlung der Alkoholgebrauchsstörung (AUD) erhalten. Das Unternehmen führt derzeit die Phase-2-Studie RECLAIM durch, in der etwa 100 Patienten eingeschlossen werden sollen, um Sicherheit und Wirksamkeit von Pemvidutide bei AUD zu beurteilen.
Die im Mai 2025 gestartete Studie wird die Teilnehmer 1:1 randomisieren und wöchentlich 2,4 mg Pemvidutide oder ein Placebo für 24 Wochen verabreichen. Primärer Endpunkt ist die Reduktion der Tage mit starkem Alkoholkonsum; sekundäre Endpunkte sind die Verringerung des WHO-Risikoniveaus für Trinkverhalten und Veränderungen alkoholbezogener Biomarker.
AUD betrifft über 28 Millionen Erwachsene in den USA, wobei nur 2% eine medikamentöse Behandlung erhalten – ein deutliches Zeichen für einen großen ungedeckten medizinischen Bedarf. Die potenzielle Wirksamkeit von Pemvidutide wird durch präklinische Studien gestützt, die eine signifikante Verringerung der Alkoholaufnahme zeigten.
- FDA Fast Track designation received for pemvidutide in AUD treatment
- Large addressable market with over 28 million adults affected by AUD in the U.S.
- Pemvidutide is the only drug currently with Fast Track designation in AUD
- Preclinical data shows significant reduction in alcohol intake
- Phase 2 trial still in early enrollment stage
- Only 100 patients planned for the trial, which may limit statistical power
- Faces competition from currently approved therapies despite their limitations
Insights
FDA Fast Track designation for pemvidutide in AUD represents significant regulatory advancement for Altimmune, addressing a serious unmet medical need.
The Fast Track designation granted to pemvidutide for Alcohol Use Disorder (AUD) marks a notable regulatory milestone for Altimmune. This designation isn't merely administrative—it provides tangible benefits including enhanced FDA communication, potential rolling review, and possibly priority review of an eventual New Drug Application. These advantages can materially accelerate the development timeline.
What's particularly significant is that pemvidutide is the only drug currently with Fast Track designation in AUD, positioning Altimmune uniquely in this therapeutic area. The market opportunity is substantial—over 28 million adults in the U.S. suffer from AUD, yet only 2% receive medication. This treatment gap represents both an unmet medical need and a commercial opportunity.
The scientific rationale for pemvidutide in AUD is compelling. The dual mechanism combining GLP-1 agonism (shown to reduce alcohol cravings) with glucagon activity (which addresses hepatic steatosis and inflammation) provides a differentiated approach. Up to 90% of problem drinkers develop fatty liver, which increases risk for alcohol-associated hepatitis. Preclinical models showing reduction in alcohol intake provide early validation.
The ongoing RECLAIM Phase 2 trial will evaluate pemvidutide 2.4 mg versus placebo in 100 patients over 24 weeks. The primary endpoint (reduction in heavy drinking days) and secondary endpoints (WHO risk drinking level reduction and PEth biomarker changes) are clinically meaningful and align with regulatory expectations for AUD trials. Trial completion will provide critical data for advancing pemvidutide's clinical development in this indication.
Pemvidutide is the only drug currently granted Fast Track Designation in AUD
RECLAIM, a Phase 2 trial of pemvidutide in AUD, is currently enrolling
GAITHERSBURG, Md., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing peptide-based therapeutics for liver and cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pemvidutide for the treatment of Alcohol Use Disorder (AUD). Fast Track designation is intended to accelerate the development and review of new drugs that target serious conditions and address unmet medical needs.
RECLAIM (NCT06987513), a Phase 2 trial evaluating the safety and efficacy of pemvidutide in AUD, is currently enrolling. Approximately 100 patients will be randomized 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial is the change from baseline in the average number of heavy drinking days, with key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization (WHO) risk drinking level and absolute change from baseline in average levels of phosphatidylethanol (PEth), a serum biomarker of alcohol intake. The trial began enrolling in May 2025.
“Despite an estimated prevalence of AUD in more than 28 million adults in the U.S. alone, the scarcity of effective treatment options has created a sizeable treatment gap in AUD, with only
Scott Harris, M.D., Chief Medical Officer of Altimmune added, “There is a clear scientific rationale for the use of pemvidutide in AUD. Fatty liver develops in up to
Fast Track designation is designed to facilitate development and expedite the review of therapies with the potential to treat serious or life-threatening conditions that demonstrate the potential to address a major unmet medical need. Product candidates that receive Fast Track designation have the opportunity to benefit from early and frequent communication with the FDA and may be eligible for rolling submission and priority review of a New Drug Application (NDA).
About AUD
Alcohol use disorder (AUD) is a medical condition driven by an impaired ability to stop or control the harmful consumption of alcohol. Alcohol use disorder can also lead to serious downstream health consequences, including liver disease, cardiovascular disease, and cancer. Additionally, most patients with AUD have comorbid overweight or obesity and present with liver steatosis, further amplifying their risk for poor outcomes. The World Health Organization estimates that harmful alcohol consumption is the seventh leading cause of global death and disability, with alcohol accounting for
Today, it is estimated that 28 million adults in the U.S. suffer from AUD. Patients with AUD are characterized as mild, moderate or severe according to the DSM-5 criteria with approximately 12 million having moderate or severe forms of the disease. Only three drugs for AUD have been approved by the FDA, but these agents have limited efficacy for AUD and its comorbidities, and are used by less than
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), 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 FDA granted Fast Track designation to pemvidutide for the treatment of MASH. 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 product candidate is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of MASH, Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (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, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing RECLAIM, RESTORE 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
This press release was published by a CLEAR® Verified individual.
FAQ
What is the significance of FDA Fast Track designation for Altimmune's pemvidutide?
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