Altimmune Announces Data from RECLAIM Phase 2 Trial of Pemvidutide in Alcohol Use Disorder Selected as Late-Breaking Oral Presentation at AASLD The Liver Meeting® 2026

The trial met key secondary endpoints validated by the FDA as registrational endpoints.

Rhea-AI Summary

Altimmune (ALT) will present RECLAIM Phase 2 results for pemvidutide in alcohol use disorder at The Liver Meeting on November 9, 2026.

The late-breaking oral presentation covers adults with moderate-to-severe alcohol use disorder. The randomized, double-blind, placebo-controlled trial compared once-weekly pemvidutide 2.4 mg with placebo over 24 weeks. Topline results announced in July 2026 showed a statistically significant reduction in heavy drinking days per week versus placebo, meeting the primary endpoint. The trial also met key secondary endpoints, including reduced World Health Organization Risk Drinking Levels and zero heavy drinking days. Altimmune described tolerability as generally favorable.

An End-of-Phase 2 FDA meeting is scheduled for December to discuss the Phase 3 registrational program for pemvidutide in alcohol use disorder.

4 points · 1 major

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Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 0 points

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Positive

• Major pointPrimary endpoint met: pemvidutide significantly reduced heavy drinking days per week versus placebo in RECLAIM.
• Moderate pointKey secondary endpoints met: reduced WHO Risk Drinking Levels and zero heavy drinking days, both FDA-validated registrational endpoints.
• Minor pointTolerability was generally favorable, Altimmune reported.
• Minor pointDecember FDA meeting is scheduled to discuss the Phase 3 registrational program in alcohol use disorder.

Negative

• None.

Key Figures

Pemvidutide dose: 2.4 mg Study duration: 24 weeks End-of-Phase 2 FDA meeting: December

Pemvidutide dose

2.4 mg

Once-weekly RECLAIM Phase 2 study arm

Study duration

24 weeks

RECLAIM Phase 2 trial

End-of-Phase 2 FDA meeting

December

Discussion of the Phase 3 registrational program for pemvidutide in AUD

Key Terms

alcohol use disorder, glp-1 receptor agonist, randomized, double-blind, +2 more

6 terms

alcohol use disorder medical

"adults with moderate-to-severe alcohol use disorder (AUD)"

A chronic medical condition characterized by an inability to control or stop drinking despite negative effects on health, work, relationships or safety; it ranges from mild to severe based on frequency, loss of control, and withdrawal symptoms. Investors care because its prevalence and treatment options affect markets for pharmaceuticals, medical services and health-related productivity—think of it like a long-running equipment fault in a factory that reduces output and creates demand for repairs and preventive solutions.

glp-1 receptor agonist medical

"an investigational balanced 1:1 glucagon/GLP-1 receptor agonist"

A GLP-1 receptor agonist is a medicine that mimics a natural gut hormone to trigger insulin release, slow stomach emptying, and curb appetite — like using a key to turn on a lock that controls blood sugar and hunger signals. For investors, these drugs matter because they treat common conditions such as diabetes and obesity, can drive large prescription and sales growth, reshape healthcare costs, and heavily affect drug pipelines, competition and company valuations.

randomized medical

"a randomized, double-blind, placebo-controlled trial"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"a randomized, double-blind, placebo-controlled trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"a randomized, double-blind, placebo-controlled trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

end-of-phase 2 meeting regulatory

"scheduled to meet with the FDA in December for an End-of-Phase 2 meeting"

An end-of-phase 2 meeting is a formal discussion between a drug developer and a regulatory agency to review mid-stage clinical results and agree on the plan and requirements for the larger, final tests needed for approval. It matters to investors because the meeting can clarify what evidence regulators will require, shape the cost and timeline for the next phase, and reduce uncertainty about whether a drug can advance toward market — like a checkpoint that determines whether a project gets the green light to move to the next, expensive stage.

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First presentation at a scientific conference of key data from RECLAIM, a multicenter Phase 2 trial of a balanced 1:1 glucagon/GLP-1 receptor agonist in alcohol use disorder (AUD)

Presentation to take place on Monday, November 9, 2026, at The Liver Meeting

Company scheduled to hold End-of-Phase 2 meeting with FDA in December

MORRISTOWN, N.J., Nov. 05, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a biopharmaceutical company advancing pemvidutide, an investigational balanced 1:1 glucagon/GLP-1 receptor agonist, in serious liver diseases, today announced that a late-breaking abstract featuring results from the RECLAIM Phase 2 trial evaluating pemvidutide in adults with moderate-to-severe alcohol use disorder (AUD) has been accepted as an oral presentation at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting^® 2026, taking place November 5-9, 2026, in Denver, Colorado.

This first presentation at an international scientific conference will feature key results from RECLAIM, a randomized, double-blind, placebo-controlled trial evaluating once-weekly pemvidutide 2.4 mg versus placebo over 24 weeks. In topline results announced in July 2026, pemvidutide achieved the trial’s primary endpoint of a statistically significant reduction in heavy drinking days (HDD) per week compared with placebo, and met key secondary endpoints validated by the U.S. Food and Drug Administration (FDA) as registrational endpoints, including reduction in World Health Organization (WHO) Risk Drinking Levels and zero HDD, with a generally favorable tolerability profile.

Late-breaking abstracts at The Liver Meeting are reserved for new, scientifically important findings from prospective large clinical studies or high-impact translational research that could not be completed before the regular abstract deadline.

Details of the late-breaking oral presentation are as follows:

• Abstract Title: Efficacy and Safety of Pemvidutide in the Treatment of Adults with Alcohol Use Disorder: Results from RECLAIM, a 24-Week Phase 2 Randomized Double-Blind Placebo-Controlled Trial
• Session: Late-Breaker Session 3
• Date/Time: Monday, November 9, 2026, 10:30 a.m. MT / 12:30 p.m. ET
• Presenter: Henry R. Kranzler, M.D. Professor of Psychiatry and Director of the Center for Studies of Addiction at the University of Pennsylvania’s Perelman School of Medicine

A copy of this presentation will be accessible on the Events section of the Altimmune website immediately following the late-breaker session.

Additionally, the Company is scheduled to meet with the FDA in December for an End-of-Phase 2 meeting to discuss the Phase 3 registrational program for pemvidutide in AUD.

About RECLAIM

RECLAIM (NCT06987513) is a Phase 2 trial evaluating the safety and efficacy of pemvidutide in Alcohol Use Disorder (AUD) patients with BMI >25 kg/m², and is the first Phase 2 multicenter study evaluating a dual glucagon-GLP-1 agonist in AUD to report results. Approximately 100 patients were randomized 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial was the change from baseline in the average number of heavy drinking days (HDD) per week, with secondary endpoints including the proportion of patients achieving a 2-level reduction in World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD, and absolute change from baseline in average levels of phosphatidylethanol (PEth), an objective serum biomarker of alcohol intake. The 2-level reduction in WHO risk drinking levels and zero HDD are recognized by the FDA as registrational endpoints.

About Pemvidutide

Pemvidutide is a novel investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity that has an effect on reducing liver fat, inflammation, and fibrosis, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss and are involved in pathways related to craving and reward.

The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced topline 48-week data from the IMPACT Phase 2b trial in MASH. In July 2026, the PERFORMA Phase 3 trial, a global, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH was initiated. In July 2026, the Company announced positive topline results from the RECLAIM Phase 2 trial in AUD. In August 2026, the Company announced completion of enrollment of the RESTORE Phase 2 trial in ALD.

About Altimmune
Altimmune is a biopharmaceutical company developing pemvidutide for patients with serious liver diseases. Pemvidutide, a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio, is in late-stage clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), recently showed robust results in the RECLAIM Phase 2 trial in alcohol use disorder (AUD) and is being studied in alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.

Investor Contact:
Luis Sanay, CFA
ir@altimmune.com

Media Contact:
Marisa Sharkey
media@altimmune.com

FAQ

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What did Altimmune’s RECLAIM Phase 2 trial show for pemvidutide in alcohol use disorder?

Pemvidutide met the primary endpoint of a statistically significant reduction in heavy drinking days per week versus placebo. The 24-week trial also met key secondary endpoints, including reduced WHO Risk Drinking Levels and zero heavy drinking days. Altimmune described the tolerability profile as generally favorable.

What is the next development step for Altimmune’s pemvidutide in alcohol use disorder?

Altimmune is scheduled to hold an End-of-Phase 2 meeting with the FDA in December to discuss the Phase 3 registrational program for pemvidutide in alcohol use disorder.