Essentialis, FDA enter agreement on SPA for DCCR Phase 3 efficacy study in patients with high triglycerides

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Essentialis, Inc. announced today that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 efficacy study required for product registration for its product candidate, Diazoxide Choline Controlled Release Tablet (DCCR), for the treatment of patients with very high triglycerides.  Essentialis and FDA agreed upon the patient population to study, inclusion and exclusion criteria, study duration, dosage, endpoints and their analyses.

"We are very pleased with the FDA's decision, as we believe the data which will be obtained in the proposed trial is anticipated to support the approval of DCCR in the patient population studied, the millions of people with very high triglycerides," commented Neil Cowen, Ph.D., President and Chief Scientific Officer for Essentialis. Currently, there are a limited number of therapeutic options for the treatment of very high triglycerides, but only DCCR works primarily by significantly reducing the production by the liver of harmful triglyceride-rich lipoprotein particles. "Due to the unique mechanism of action, DCCR has the potential to be an important advance in the treatment of patients with very high triglycerides" he added.

Aaron Berg, Chief Commercial Officer for Essentialis added, "We would like to thank FDA reviewers for their guidance during the SPA approval process and are pleased that the Agency has indicated an agreement to proceed with this Phase 3 pivotal study for DCCR. The positive outcome of the SPA process means Essentialis has now reached a major developmental milestone for DCCR." Essentialis is currently seeking a partner to assist with Phase 3 and near-term commercialization.

Source:

Essentialis, Inc.

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