DCCR

DCCR is the first and only pharmaceutical option for at-risk VHTG patients already on other TG-lowering drugs. Approximately 60% of VHTG patients are treated with TG-lowering therapy, yet use of combination therapy for lowering TG is rather limited. For example, Lovaza is used with fenofibrate less than 15% of the time.

DCCR is a novel, crystalline patent-protected salt of diazoxide formulated as a controlled release once-a-day tablet. Diazoxide free base is approved as a three-times-a-day oral suspension (Proglycem®) that has been used safely for decades in tens of thousands of patients. Diazoxide is first line therapy in a range of orphan indications in neonates, children and adults. Over the last 40 years, there have been more than 3000 peer reviewed publications covering in-vitro, animal model, and clinical results with diazoxide.

Essentialis has assembled an extensive toxicological package on the product which shows a wide margin of safety for therapeutically relevant doses.

Essentialis is pursuing a 505(b)(2) registration process for DCCR.

DCCR is protected by an extensive intellectual property (IP) portfolio anchored by composition of matter patent protection. It is covered by multiple issued US and granted European composition of matter patents which provide protection to the active, the pharmaceutical formulation, methods of use and co-administration and co-formulation with lipid-lowering and other classes of drugs. This IP protection on DCCR extends to 2028.

Essentialis has completed 5 phase 1 clinical studies and 2 phase 2 clinical studies with DCCR.

The overall development plan for DCCR was discussed in an End-of-Phase 2/SPA meeting with the FDA in December 2009 and concurrence was reached on the non-clinical and Phase 1 studies required to support approval. An SPA agreement has been reached with the FDA in October 2010 for a pivotal study to support approval of DCCR in VHTG patients.