The National Center for Complementary and Intergrative Health, of Institutes of Health Awards a grant in the amount of $320,159 to TheraPYX, Inc.
Buffalo, New York – June 8th, 2018 TheraPYX, Inc. is pleased to announce a new SBIR Phase I award to explore development of micro-encapsulated Epigallocatechin gallate (EGCG), the most abundant catechin in green tea and the subject of extensive basic research for its potential to affect human health and disease. This considerable attention is due to several epidemiological and clinical studies which have shown a positive relationship between green tea consumption and disease prevention. Studies have reported a reduced risk of cardiovascular diseases (e.g. myocardial infarction, hypertension, atherosclerosis), neurodegenerative diseases (e.g. Parkinson’s and Alzheimer’s disease), and certain cancers (e.g. gastric, breast and cervical cancer). Supplements have even been shown to help maintain healthy body weight and lipid profile. However, toxicity, acid-induced hydrolysis in the stomach, enzymatic degradation, instability and poor oral bioavailability often combine to limit efficient delivery via the oral route. Encapsulation into sustained-release biodegradable microspheres provides protection and allows safe passage through the stomach and retention into the lumen of the gut for uptake. TPX-EGCG is our propriety formulation of micro-encapsulated EGCG. The hope is that local delivery will mean lower effective doses and reduced toxicity. TPX-EGCG could also provide prophylactic benefits across a wide range of inflammatory, neoplastic, cardiovascular, neurological and metabolic disorders. Thus, the broad anti-inflammatory potential of green tea, long recognized by the ancients, may at last be translated into demonstrable benefit to patients.
The grant was awarded to Dr. Dominick L. Auci, MBA, PhD of TheraPYX, Inc. and Dr. Gerald W. Dryden, MD, Ph.D., Professor of Medicine and Director of the Inflammatory Bowel Disease Program, Department of Medicine, Gastroenterology, Hepatology and Nutrition at the University of Louisville. Dr. Dryden performed the only clinical study demonstrating efficacy of oral EGCG in patients with inflammatory bowel disease. TheraPYX, Inc. has obtained clinical grade EGCG from Tea Solutions, Inc that will be used in the studies. If successful, our EGCG drug product may be eligible for the 505(b)(2) accelerated development pathway.
“We are very pleased with this phase I SBIR award” said Dr. Dominick L. Auci, Vice President for Research and Development. “and excited to be working with Dr. Dryden, a world-renowned expert on the effects of EGCG in IBD. This new award will allow us to test our hypothesis that encapsulated EGCG (TPX-EGCG) can provide greater benefit and reduced toxicity when compared to the un-encapsulated drug substance.”
TheraPYX, Inc. also continues the development of it other products, TreXTAM TM, NGoXIMTM and GneX12TM towards clinical trials. The company also has a deep pipeline of discovery stage products, including ATRAXiMTM and FAPXILTM that will soon progress into development. Certain of these products may be eligible for orphan status as well as 505(b)(2) accelerated development pathway.
TheraPYX. Inc. is developing a proprietary drug delivery system called EXStaM based on encapsulation of highly potent protein therapeutics into micro-particles that preserves bioactivity, achieves controlled tissue specific release, reduced toxicity and shelf-stability at room temperature. Its lead products NGoXIMTM and TreXTAMTM are aimed at mucosal infections and immune mediated inflammatory diseases respectively. For more information on TheraPYX, Inc. contact the Company through its website at www.therapyxinc.com.