Therapix Biosciences Ltd (NASDAQ:TRPX) is a clinical-stage specialty pharmaceutical company developing therapeutics based on a proprietary oral pill formulation of dronabinol + PEA, both FDA-approved drugs, currently being tested for the treatment of Tourette’s (Phase IIa) and mild cognitive impairment (MCI) (Phase I/II), both Orphan Drug Candidates.
Tourette’s syndrome is currently treated by four approved drugs, all with significant side effects, and MCI currently has no approved treatment options. Data suggest that Therapix will have success in treating both. Due to Therapix’s formulation combining two FDA-approved drugs, it is seeking a 505(b)(2) regulatory strategy, which will save significant time and capital during the evaluation process, considerably de-risking drug development. Therapix expects Phase IIa clinical data announcements in Q417 and Q118 from its two Tourette’s clinical studies at Yale and Hannover.