HT942523C0067

Small Business Innovation Research Program (SBIR) Phase II

Development for ShockDefender against Hemorrhagic Shock

Hemorrhagic shock is responsible for over 35% of prehospital traumatic deaths and over 40% of all deaths within the first 24 hours following injury. Multiple intervention strategies are necessary for prolonged prehospital management and improved casualty survivability including improved blood products, hemostatics, damage control resuscitation, as well as therapeutic interventions targeting coagulopathy, immune modulation, metabolic and inflammatory processes. Pharmaceutical interventions near or at the point of injury in prolonged field care settings are particularly valuable to mitigate or delay the pathophysiologic consequences of hemorrhagic shock, ultimately enabling survival to a higher level of care. Preliminary studies established the rationale of the proposed anti-shock inhibitor drug to prolong casualty survivability by modulating the metabolic and inflammatory processes. Zymeron develops a safe and easy-to-use pharmacological intervention with significant protective effects for casualties undergoing hemorrhagic shock in combat or other austere environments. The intramuscular injection formulation of an FDA approved oral tablet has improved bioavailability and faster onset of action that is stored in a dual chamber autoinjector, enabling prolonged shelf life and rapid intramuscular use at the point of injury. The high inhibitory effect at 5 nM of EC50 through the regulation of tissue metabolism, prevention of cell death, and suppression of inflammation provide substantial survival benefits for hemorrhage and trauma casualties. The Phase II program will conduct all required IND-enabling safety and efficacy studies as well as address various manufacturing, quality control and regulatory issues, to reach an end state of IND ready status.

The goal of phase II is to continue the R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II.

DHA234-D001

H2D-0119

23.4

Jason Zhiguo Zhou