Encore Therapeutics, Inc. (ETI) today reported finalizing its proprietary phospholipid nanoemulsion formulation of progesterone (ETI-411). Existing progesterone formulations for Traumatic Brain Injury (TBI) are not suitable for commercial development because they are imprecisely formulated at the bedside, resulting in potential variations in drug dosing and the failure to meet strict release specifications required by regulatory authorities. In addition these formulations lack intellectual property protection and contain components that are not suitable for long-term infusion.
ETI-411 was developed to obviate these deficiencies and generate a progesterone based neuroprotection product suitable for approval and that would justify the requisite development investment. ETI-411 comes in a lyophilized format that can easily be reconstituted at the hospital bedside or by the battlefield medic to meet strict QC specifications. The proprietary formulation contains FDA-approved excipients that are suitable for extended bolus and prolonged infusion. In addition, the ETI-411 formulation uses the same formulation technology present in two other continuous infusion NDA-stage drugs, which validates its safety and approvability.
Today's announced completion of a 30 month stability study concludes a four year development project and establishes a two year shelf life for ETI-411 and clearly shows that the nanoemulsion can be easily reconstituted to meet the product release specifications. These data satisfy the chemical requirements for a commercially viable progesterone formulation product.
Paul J. Marangos, ETI's CEO, stated, "We believe ETI-411 will enable the transition of progesterone from a research tool to a commercially viable product. The lack of patent protection and an approvable formulation have impeded the development of progesterone therapeutics for TBI and threaten to slow the application of the current large NIH sponsored phase III progesterone TBI clinical trial to support an approvable product." Andrew X. Chen, ETI's Chief Technical Officer and inventor of the nanoemulsion formulation, further added, "The current study clearly establishes the capability for the progesterone nanoemulsion to be easily reconstituted and to meet key stringent release specifications. This was only achieved after evaluating numerous emulsion stabilization techniques and lyophilization cycles."
Encore Therapeutics, Inc.