Pharma giant Altimmune claims that its Pemvidutide has shown promising 48-week results in liver disease trial.

 

The topline data from IMPACT Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH) show sustained reductions in key non-invasive liver fibrosis markers—including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM)—with improvements continuing beyond week 24. 

 

The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile, with fewer discontinuations due to adverse events than placebo.

 

“The magnitude of response versus placebo on measures such as ELF and LSM at 48 weeks makes these data particularly compelling, as these noninvasive markers have been shown to correlate with histologic fibrosis stage,” said Mazen Noureddin, IMPACT trial principal investigator, Professor of Medicine at Houston Methodist Hospital, and Co-Chairman of the Board for Summit and Pinnacle Clinical Research. 

 

“These results reinforce that pemvidutide may address both liver-specific and metabolic drivers of MASH without compromising tolerability – three critical elements of a potential effective treatment for this patient population. I am encouraged by the dose response observed and the performance of the 1.8 mg arm and I am eager to see this differentiated therapeutic candidate advance into Phase 3 evaluation.”

 

Altimmune also confirmed a productive End-of-Phase 2 meeting with the FDA, aligning on Phase 3 trial parameters and securing support to integrate the AIM-MASH AI Assist tool, which standardizes histologic assessment and speeds MASH drug development.

 

“With the benefit of FDA feedback and these 48-week data now in hand, we are greatly looking forward to progressing pemvidutide to a Phase 3 program which we intend to initiate in 2026,” said Vipin Garg, Chief Executive Officer of Altimmune. 

 

“Strong evidence of antifibrotic improvements based upon non-invasive tests, combined with an attractive tolerability profile, highlight pemvidutide’s differentiation and potential to be a meaningful treatment option for the MASH patient community.”

 

The IMPACT Phase 2b study enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2 or F3. Patients were randomized 1:2:2 to receive weekly pemvidutide (1.2 mg or 1.8 mg) or placebo for 48 weeks.