Altimmune Launches Phase 3 for Pemvidutide

Clinical Milestone: PERFORMA Phase 3 Trial Launches

Altimmune, Inc. (Nasdaq: ALT) announced the initiation of the PERFORMA Phase 3 clinical trial on August 3, 2026. This global, registrational study evaluates the efficacy and safety of pemvidutide in patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis. The trial marks a significant advancement for Altimmune’s lead program, moving pemvidutide into late-stage development following positive data from the preceding IMPACT Phase 2b study.

Pemvidutide is an investigational peptide designed as a balanced glucagon/GLP-1 dual receptor agonist. It is currently under development for the treatment of MASH, alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). The mechanism of action leverages glucagon receptor activation for direct hepatic effects and GLP-1 receptor activation for metabolic benefits, including appetite suppression and weight loss.

Trial Design and Regulatory Strategy

The PERFORMA study is structured as a global, randomized, double-blind, placebo-controlled, parallel-group trial. It aims to assess fibrosis improvement, MASH resolution, and broader clinical outcomes. The trial incorporates feedback received from regulatory agencies and is designed to support accelerated approval pathways.

The study comprises two distinct cohorts. Cohort 1 will enroll approximately 990 patients and utilizes a biopsy-assessed primary efficacy endpoint to measure MASH resolution and fibrosis improvement at 52 weeks. This cohort is critical for supporting accelerated approval. A second cohort will enroll approximately 800 patients, utilizing non-invasive tests (NITs) to provide additional safety data. The final regulatory approval decision will be based on liver-related events observed over a period of approximately 60 months.

To ensure standardization in histological assessment, the trial integrates the FDA-qualified AIM-MASH AI Assist tool. The dosing regimen involves a simple monthly titration from 1.2 mg to either 1.8 mg or 2.4 mg, a strategy implemented to enhance patient tolerability. The company anticipates a 52-week data readout from the trial in 2029.

Preceding Clinical Success and Designations

The progression to Phase 3 follows encouraging results from the IMPACT Phase 2b study. Topline data from that trial, announced in December 2025, demonstrated statistically significant MASH resolution rates, improvements in non-invasive fibrosis measures, meaningful weight loss, and a favorable tolerability profile. Based on these findings, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation and Breakthrough Therapy Designation to pemvidutide for the treatment of MASH.

Additionally, the company announced positive topline results from the RECLAIM Phase 2 trial in AUD in July 2026. The RESTORE trial in ALD, which was initiated in July 2025, is expected to complete enrollment in the third quarter of 2026.

Executive Commentary

Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune, stated that the body of evidence, including favorable safety and tolerability profiles from the IMPACT Phase 2 trial, supports the potential of pemvidutide as it advances into the PERFORMA Phase 3 trial. He noted that the balanced one-to-one glucagon/GLP-1 receptor agonism offers direct effects on the liver alongside metabolic benefits, potentially providing a new treatment option for patients with serious liver diseases.

Jerry Durso, Chief Executive Officer and Chairman of the Board, described the initiation of the PERFORMA trial as a key milestone. He emphasized the company’s speed and efficiency, noting that the transition from securing funding to initiating the trial occurred within three months. Durso highlighted the company’s focus on building momentum across the pemvidutide program in multiple indications.

Market Context

On August 3, 2026, ALT dropped by 0.52% within 24 hours to reach $0.00571. The stock rose by 0.35% within 7 days, dropped by 2.06% within 1 month, and dropped by 12.42% within 1 year.