Altimmune (NASDAQ:ALT) said it has initiated patient enrollment in its global Phase III PERFORMA trial of pemvidutide for metabolic dysfunction-associated steatohepatitis, or MASH, while advancing plans for later-stage development in alcohol use disorder, or AUD.
Chairman and Chief Executive Officer Jerome Durso said 2026 has marked significant progress as the company focuses on serious liver diseases. The company began enrolling patients in PERFORMA about three months after securing funding intended to support the program through its 52-week data readout.
Phase III MASH Program Underway
The company said it has sought to reduce screening failures and pathology variability through the trial design, including use of AIM-MASH AI-assisted pathology. Under the process described on the call, digitized biopsy slides will be assessed by the AI system, which will identify features and propose scores for pathologists to review. Pathologists will remain responsible for final scoring under a consensus-reading process.
Altimmune said patients using GLP-1 therapies at antidiabetic doses may be included in PERFORMA. However, patients using Rezdiffra will not be included because the company does not want to compromise the trial’s 52-week biopsy endpoint. The company also plans to characterize patients who previously did not respond to or could not tolerate GLP-1 therapies or Rezdiffra.
The company expects the PERFORMA 52-week data readout in 2029.
AUD Data Supports Regulatory Planning
Altimmune in July reported positive topline results from the Phase II RECLAIM trial in AUD. Arbet-Engels said the 2.4-milligram dose of pemvidutide met the primary endpoint by reducing heavy drinking days by 1.45 per week versus placebo at week 24.
The trial also met secondary endpoints that the company said are recognized by the FDA as potential registrational measures. Roughly two-thirds of pemvidutide-treated patients achieved a two-level reduction in World Health Organization risk drinking levels, compared with about one-third of placebo patients. More than twice as many pemvidutide patients achieved zero heavy drinking days versus placebo, according to the company.
Altimmune also reported statistically significant changes in abstinent drinking days, phosphatidylethanol, or PEth, levels, and body weight. The company said pemvidutide patients had a 9.1% reduction in body weight from baseline versus placebo.
In an exploratory analysis among patients with a baseline FIB-4 score above 1.3, Altimmune said 50% of pemvidutide-treated patients moved below that threshold after 24 weeks, compared with 17% of placebo patients. FIB-4 is a biomarker associated with risk of liver fibrosis.
The company plans to prepare a data package for an end-of-Phase-II meeting with the FDA and also expects to engage European regulators. Arbet-Engels said the company currently expects one global pivotal AUD trial could be sufficient, subject to regulatory discussions.
A potential Phase III AUD program would focus on moderate-to-severe AUD, could include patients with a body mass index below 25, and may evaluate lower-dose options. Altimmune said it would likely use a 24-week primary efficacy endpoint while following patients through 52 weeks for further analyses and safety data. The company has not provided guidance on trial timing.
ALD Enrollment Completed
Altimmune said it completed enrollment in the Phase II RESTORE trial in alcohol-associated liver disease, or ALD. The study enrolled about 120 patients with ALD and a history of chronic heavy drinking, and topline data are expected in the second half of 2027.
The company amended the RESTORE protocol so that liver stiffness measurements will be assessed hierarchically at week 48 and then at week 24. Altimmune said the change is intended to better characterize potential liver benefits over one year and support future regulatory discussions.
Management said the protocol change did not alter the study’s population or power assumptions. The company also said a separate hepatic-impairment study enabled it to broaden RESTORE eligibility for patients with higher liver stiffness measurements, after observing no added risk in that population.
Second-Quarter Financial Results and Runway
Altimmune reported a second-quarter net loss of $22.8 million, or $0.12 per share, compared with a net loss of $22.1 million, or $0.27 per share, in the prior-year quarter.
- Research and development expense was $18.7 million, up from $17.2 million a year earlier.
- General and administrative expense was $7.6 million, compared with $5.7 million in the prior-year period.
- R&D spending included $11.6 million in direct pemvidutide-development costs, including $3.8 million for MASH, $5.3 million for Phase II AUD and ALD trials, and $2.5 million for chemistry, manufacturing and controls activities.
Chief Financial Officer Greg Weaver said Altimmune raised approximately $310 million year to date, including a $225 million follow-on offering in April. The company had $519 million in cash as of June 30.
Weaver said the cash balance is expected to fund operations through the PERFORMA Phase III MASH 52-week readout in 2029, but does not include funding for a potential Phase III AUD trial. The company said its preference is to use non-dilutive financing for that program, potentially including royalties, debt or strategic partnerships.
About Altimmune (NASDAQ:ALT)
Altimmune, Inc is a clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics. The company leverages proprietary technology platforms to create intranasal vaccine candidates and novel therapies targeting liver diseases and metabolic disorders. Altimmune’s approach emphasizes the stimulation of both systemic and mucosal immune responses to address unmet medical needs in infectious and chronic conditions.
Among its lead programs, NasoVAX is an investigational intranasal influenza vaccine designed to provide broad, long-lasting protection through a single, non-invasive dose.
