Altimmune's RESTORE TRIAL: A Promising Step in ALD Treatment

Altimmune is recruiting for a Phase 2 study called RESTORE TRIAL to evaluate the efficacy and safety of Pemvidutide for treating Alcohol-Associated Liver Disease (ALD). The trial is ongoing and has started recruiting participants. Successful trial outcomes could positively impact Altimmune's stock performance and enhance the company's position in the liver disease treatment sector.

Altimmune, Inc. (NASDAQ: ALT), a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases, has initiated the RESTORE Phase 2 trial to evaluate the efficacy and safety of pemvidutide for treating Alcohol-Associated Liver Disease (ALD). The trial, which began enrolling participants on July 9, 2025, is a randomized, placebo-controlled study that will enroll approximately 100 patients across 34 sites [1].

Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist that targets a significant medical need, as over 6 million Americans with Alcohol Use Disorder have progressed to ALD, a condition currently lacking approved treatments [1]. The trial's primary endpoint focuses on changes in liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) at Week 24, with secondary endpoints including measurements at Week 48, Enhanced Liver Fibrosis (ELF) score changes, and alterations in alcohol consumption and body weight [1].

The RESTORE trial follows FDA clearance of the investigational new drug (IND) application for pemvidutide in ALD, which was granted in January 2025 [1]. The trial design is robust, with patients randomized 1:1 to either 2.4mg pemvidutide or placebo for 48 weeks. The involvement of Dr. Rohit Loomba, a recognized expert in liver disease and principal investigator of the RESTORE trial, adds credibility to this clinical program [1].

Altimmune's expansion of pemvidutide into ALD represents strategic pipeline growth targeting a large unmet medical need with encouraging preliminary data from the IMPACT Phase 2b trial in Metabolic Dysfunction-Associated Steatohepatitis (MASH) [2]. The company is leveraging the dual mechanism of action of pemvidutide, which affects both weight loss and liver-specific improvements, to provide unique therapeutic benefits.

Successful outcomes from the RESTORE trial could positively impact Altimmune's stock performance and enhance the company's position in the liver disease treatment sector. The trial's results are expected to provide valuable insights into the potential of pemvidutide as a treatment for ALD, a condition with significant unmet medical needs.

References:
[1] https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-initiation-restore-phase-2-trial-evaluating
[2] https://www.stocktitan.net/news/ALT/altimmune-announces-initiation-of-restore-phase-2-trial-evaluating-6iqauh4ylo0m.html