Altimmune Initiates RESTORE Phase 2 Trial for Liver Disease Treatment

Altimmune (ALT) has initiated its Phase 2 RESTORE trial to evaluate pemvidutide for treating Alcohol-Associated Liver Disease (ALD). The trial involves 100 participants and will assess liver stiffness, Enhanced Liver Fibrosis score, and alcohol consumption changes over 48 weeks. The FDA approved pemvidutide in December 2024. Analysts forecast an average target price of $22.38, implying a 388.54% upside from the current price of $4.58. Altimmune ended Q1 2025 with $150 million in cash and raised $51 million through its ATM facility and credit facility.

Altimmune, Inc. (NASDAQ: ALT), a late clinical-stage biopharmaceutical company, has announced the initiation of the Phase 2 RESTORE trial to evaluate the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD) [1]. The trial, which began on July 9, 2025, is a randomized, placebo-controlled study enrolling approximately 100 patients across 34 sites. Participants will be randomized 1:1 to receive either 2.4mg of pemvidutide or placebo for 48 weeks.

The primary endpoint of the RESTORE 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 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. The trial follows the FDA clearance of the investigational new drug (IND) application for pemvidutide in ALD, which was granted in January 2025 [1].

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. 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 [1].

The RESTORE trial is led by 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. Dr. Loomba serves as the principal investigator, highlighting the trial's robust clinical leadership [1].

Analysts forecast an average target price of $22.38 for Altimmune, implying a 388.54% upside from the current price of $4.58. Altimmune ended Q1 2025 with $150 million in cash and raised $51 million through its ATM facility and credit facility [2].

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