Altimmune, headquartered in Gaithersburg, Maryland, has enrolled its first patients in PERFORMA, the registrational Phase 3 trial testing pemvidutide in MASH, the liver disease formerly known as NASH. This is the trial that will determine whether pemvidutide has a real shot at becoming an approved treatment, and the company is moving into it with regulatory feedback from both the FDA and European agencies already built into the design.
The Trial, By the Numbers
PERFORMA is a global, randomized, double-blind, placebo-controlled study enrolling roughly 1,790 patients with MASH and moderate to advanced fibrosis, split across two parallel groups. Cohort 1 includes about 990 patients with biopsy-confirmed fibrosis and is the group supporting a potential accelerated approval pathway. Cohort 2 adds another roughly 800 patients identified through non-invasive testing rather than biopsy, which broadens the safety database without requiring every participant to undergo a liver biopsy. Dosing follows a simplified one- or two-step monthly titration from 1.2mg up to either a 1.8mg or 2.4mg target dose, a design meant to improve tolerability compared to more complex titration schedules.
The trial has two primary endpoints on two very different timelines. MASH resolution and/or fibrosis improvement at 52 weeks will support the accelerated approval pathway, with that data expected in 2029, while a longer-term endpoint tracking liver-related clinical events at around 60 months will support full, traditional approval. The trial also uses an event-driven design with a built-in interim analysis, and incorporates an FDA-qualified AI tool called AIM-MASH to standardize how liver biopsies are assessed across sites, reducing the variability that’s historically made pathologist-read biopsy endpoints harder to compare across a large, multi-site trial.
What Pemvidutide Is Actually Doing
Pemvidutide is a dual receptor agonist built around balanced, 1-to-1 activity on glucagon and GLP-1 receptors. The glucagon side is doing the liver-specific work, reducing fat accumulation, inflammation, and fibrosis directly in the liver, while the GLP-1 side delivers the more familiar metabolic effects: appetite suppression, weight loss, and effects on craving and reward pathways. That dual mechanism is also why Altimmune is chasing pemvidutide well beyond MASH, with active programs in alcohol use disorder and alcohol-associated liver disease, conditions where the same combination of metabolic and craving-related effects could plausibly help. The drug already carries FDA Fast Track designations for both MASH and alcohol use disorder, along with FDA Breakthrough Therapy designation for MASH specifically.
Why MASH Is a Hard Problem Worth Solving
MASH is one of the more consequential liver diseases in terms of sheer scale, a leading cause of fibrosis, cirrhosis, liver transplantation, and liver-related death, and it affects a population where more than 80% of patients are overweight or obese. That overlap is exactly why a drug that treats liver disease and underlying metabolic dysfunction at the same time, rather than one or the other, has generated real interest. Altimmune’s earlier IMPACT Phase 2b trial gave the company enough of a signal to build PERFORMA around: statistically significant MASH resolution, improvements in non-invasive fibrosis and liver health markers, and meaningful weight loss, alongside what the company describes as a generally favorable tolerability profile. Additional 48-week data presented at EASL 2026 also showed reductions in triglycerides (down 23.7%), total cholesterol (down 15.4%), and blood pressure (systolic down 4.0 mmHg, diastolic down 2.2 mmHg) at the 1.8mg dose versus placebo, evidence that the metabolic benefits extend beyond the liver itself.
A Maryland Biotech Moving on a Tight Timeline
Jerry Durso, Altimmune’s CEO and Chairman, pointed to the pace of execution as much as the science: “In just three months, we moved from securing funding for PERFORMA to initiating the trial, reinforcing Altimmune’s commitment to execute with speed and efficiency.” Christophe Arbet-Engels, MD, PhD, Altimmune’s Chief Medical Officer, described the therapeutic logic behind the drug directly: the balanced glucagon/GLP-1 agonism provides “direct effects on the liver, as well as metabolic benefits.” Naim Alkhouri, MD, Chief Medical Officer at Summit Clinical Research and a principal investigator on the trial, framed the broader clinical need: “MASH is a complex disease, and as clinicians, we need therapies that can effectively address both liver disease and the broader metabolic dysfunction that contributes to long-term health risks.”
For Maryland’s biotech corridor, this is a notable one to watch. Altimmune is a Nasdaq-listed, late-stage biopharmaceutical company based on Clopper Road in Gaithersburg, now running one of the larger MASH trials in the industry alongside separate active programs in alcohol use disorder and alcohol-associated liver disease. A positive readout here, even on the earlier 52-week accelerated approval endpoint, would put a homegrown Montgomery County company on a real path toward its first approved product.
