Altimmune Aligns FDA on Biopsy-Driven Phase 3 MASH Trial for 1,800 Patients
Altimmune plans a pivotal Phase 3 MASH trial enrolling 1,800 patients globally, with two primary endpoints powered at over 90% and a 2.4 mg dose cohort. The company expects increased cash burn and secured FDA alignment on biopsy-driven endpoints after regulators deemed NITs premature.
1. Phase 3 Trial Design
Altimmune has finalized the design for its pivotal Phase 3 MASH trial, planning to enroll approximately 1,800 patients globally. The study will test two primary endpoints—MASH resolution without worsening fibrosis and fibrosis improvement without MASH worsening—powered at over 90% with a 990-patient cohort per endpoint and includes a 2.4 mg dose arm for potential enhanced efficacy.
2. FDA Engagement and Endpoint Strategy
The company has secured FDA alignment on a biopsy-driven primary endpoint framework, as regulators currently consider noninvasive tests premature for registrational use. While the initial protocol focuses on F2 and F3 MASH stages, potential exists to evaluate advanced F4 fibrosis based on pemvidutide’s mechanism of action in future studies.
3. Financial Planning
As it prepares for Phase 3 launch, Altimmune anticipates increased cash burn and has begun financial planning to support operations and global trial implementation. The company is exploring funding strategies to ensure sufficient runway through top-line data readout.
4. Manufacturing and Timelines
Manufacturing readiness is in place for global trial supply, with capacity to scale as needed. The trial is slated to start later this year, with guidance on top-line data timelines to be refined as site activation progresses.