PharmAust Limited partners with Berry Consultants for Phase 2/3 MND Study

PharmAust Limited (ASX: $PAA), a clinical-stage biotechnology company, has announced its partnership with leading clinical study design specialist Berry Consultants to design and analyse the planned adaptive Phase 2/3 clinical study for monepantel in patients with Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS).

PharmAust CEO's Commentary on Partnership with Berry Consultants

We are delighted to be working with Berry Consultants as their reputation and experience in designing and conducting the statistical analysis of MND/ALS studies is unmatched. Berry Consultants has partnered with the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. The Center is currently running the largest ALS study ever undertaken, the Healey ALS Platform Trial, which is focused on accelerating the development of promising new drugs for patients with ALS. Berry Consultants was integral in the concept, design, and continual evolution of that study in addition to numerous other MND/ALS programs.

PharmAust's Partnership with Berry Consultants and Future Outlook

PharmAust Limited has partnered with Berry Consultants to design and analyse an adaptive Phase 2/3 clinical study for monepantel in patients with Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS). The collaboration aims to position monepantel for FDA approval for the treatment of MND/ALS. The company anticipates starting a Phase 2 study in H1 2024 that could lead to accelerated approval with the US Food and Drug Administration in 2026. PharmAust is focused on repurposing monepantel for human neurodegenerative diseases and treating cancer in dogs, with the lead MPL program targeting the treatment of MND/ALS, a rare, incurable disease. Top-line results of the Phase 1 study in patients with MND/ALS are expected to be announced in Q1 CY2024.