KSTC-184-512-16-235

Proposal Title Novel Drug Carrier System for the Treatment of Liver Disease
Category Human Health and Development
Abstract EndoProtech’s goal is to commercialize a therapy for Alcoholic Liver Disease. The product is a unique carrier system that targets the liver to deliver a drug that corrects pathological processes that occur in patients with, alcoholic hepatitis (AH) and/or cirrhosis. AH remains a leading cause of death from liver disease in the US, and there is still no FDA-approved therapy. There are drugs available that can correct the dysregulated pro-inflammatory response, but systemic administration of these drugs at the dose required to treat AH elicit intolerable side effects in patients. Therefore, EndoProtech has developed a drug carrier system that targets the liver and limits systemic release of drug while circulating in the blood stream to prevent side effects. The selected drug has desirable chemical properties that enhance the drug retention capacity of our carrier system thereby diminishing systemic release of drug. KSTC Matching Funds are requested to continue development of regulatory strategy, initiate preclinical studies and pilot biomanufacturing campaign and to further protect intellectual property portfolio. Furthermore, studies will be performed to demonstrate feasibility in reducing liver fibrosis. The technical tasks are: 1) Modify drug molecule to increase encapsulation efficiency; and 2) Determine the efficacy of the modified drug in our carrier system in models of AH and liver fibrosis (secondary product opportunity). These tasks will provide additional data that will support submission of an IND application to the FDA. The commercialization milestones are: 1) Develop regulatory strategy hiring expert consultants in the field; and 2) Protect and file additional patents to strengthen intellectual property estate. The use of contracted regulatory, legal, and preclinical research will enable EndoProtech to more efficiently commercialize its therapy.
Amount Awarded $500,000
Keywords Targeted drug delivery, cytokines, phosphodiasterase 4 B, drug encapsulation, anti-inflammatory, alcoholic liver disease, alcoholic hepatitis, translational research, intellectual property, patent application, biodistribution, liver, heart, alanine aminotransferase, aspartate aminotransferase, cardiopulmonary bypass
Point of Contact Claudio Maldonado
502.468.1736
[email protected]
EndoProtech Incorporated
Location Louisville
Jefferson County