The National Institutes of Health Awards a grant in the amount of $3,000,000 to Therapyx, Inc.
Buffalo, New York- June 20, 2017. Therapyx is pleased to announce a SBIR Phase IIb award to continue development of TreXTAMTM it’s first-in-class immune therapy for the treatment of inflammatory bowel disease (IBD) and potentially systemic lupus erythematosus (SLE). TreXTAMTM is a combination of particulate transforming growth factor beta 1 (TGFb) and all-trans retinoic acid (ATRA) formulated for oral delivery. The award entitled “Delivery of Nanoencapsulated TGFbeta and ATRA for the Treatment of IBD” was made from The National Institute of Allergy and Infectious Diseases of the National Institutes of Health to Dr. Dominick L. Auci, MBA, Ph.D., VP for R&D at Therapyx. It will fund additional IND-enabling formulation studies as well as rodent and non-human primate efficacy and GLP toxicology studies recommended by the FDA at our last pre-IND meeting.
“We are thrilled with this new award” said Dr. Dominick L. Auci, Vice President for Research and Development. “and excited about continuing development of TreXTAMTM. Its putative mechanism of action, the induction, activation and stabilization of regulatory T cells, would make it a first-in-class immune therapy for IBD with potential applications in autoimmune diseases such as SLE. This new award will allow us to adequately respond to previous FDA guidance and enable first-in-man phase I/II clinical studies. Importantly, the work will substantially de-risk the product, making it more attractive to potential partners.”
Therapyx also continues the development of it other products, NGoXIMTM and GneX12TM towards clinical trials. The company has a deep pipeline of discovery stage products, including PCX12TM, FAPXILTM and TPX-ECGC that will soon progress into development. Moreover, certain products are likely to be eligible for FDA orphan drug designation, as well as 505(b)(2) accelerated regulatory development pathway.
Therapyx is developing a proprietary drug delivery system based on mild encapsulation of highly potent protein therapeutics into nano/microparticles that preserves bioactivity, achieves controlled tissue specific release, reduced toxicity and shelf-stability. 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’s website at therapyxinc.com
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