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S2 E5.3 – After the FDA Webcast: Discussing Drug Development and Clinical Trial Strategies

The Surfers and guests Manal Abdelmalek, Naim Alkhouri and Akero Therapeutics Chief Development Officer Kitty Yale discuss sections of theFDA Webcast that centered on drug development and clinical trial strategies

The panel discussed key takeaways from the FDA webcast on NASH Drug Development on the subjects of clinical trial design and development strategies. Much discussion centered around parallel clinical trials for F2/F3 and controlled cirrhotic patients, both in terms of rethinking endpoints (is it sufficient to “halt” progression?) and designing sets of parallel trials to the sponsor’s best benefit. Another key topic involved combination of combination therapies and practical issues around moving to combination approvals prior to having an acceptable set of monotherapies available. The third major area of interest involved length of trial for newer medications that are producing dramatic Phase 2 results in as little as 12-16 weeks.

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