Essentialis plans to file a Special Protocol Assessment (SPA) with FDA for the pivotal study to support the NDA filing for its drug, DCCR. The drug is intended for the treatment of very high triglycerides.
Reportedly, the proposed study would include 280 randomized subjects with the primary efficacy endpoint assessed at 12 weeks. The decision followed a productive Type C meeting with FDA on July 30th, where the overall development plan for DCCR and the non-clinical package supporting the NDA were reviewed and discussed.
Iain Dukes, president and CEO of Essentialis, said: The submission of the SPA will bring us one step closer towards filing for approval of DCCR for the treatment of patients with very high triglycerides. This development, along with positive Phase 2 study results and the recent issuance of a US patent providing extensive protection to DCCR, underscores the tremendous clinical and commercial potential of this drug worldwide.