About Therapix Biosciences — Company Overview
Therapix Biosciences Ltd. (NASDAQ: TRPX; TASE: THXBY) is an emerging specialty pharmaceutical company developing unique cannabinoid technologies in treatment of central nervous system (CNS) disorders.
Therapix is engaged in two drug development programs based on repurposing an FDA, approved synthetic cannabinoid (dronabinol):
- THX-TS01: for the treatment of symptoms related to Tourette Syndrome (TS), and
- THX-ULD01: targeted to the high value and under-served market of mild cognitive impairment (MCI)
Therapix has filed for Orphan Drug Designation for its THX-TS01 program formulation, which provides for a seven-year exclusive marketing period in the United States. Therapix also intends to pursue Orphan Drug Designation in Europe.
In a letter dated September 29, 2016, the FDA informed us that our request cannot be granted at this time, and is being held in abeyance until and subject to us providing the FDA additional information pertaining to the overall prevalence of TS in both children and adults, and further clinical data to support our scientific rationale for our request for orphan drug designation within 12 months. We intend to respond within the 12 month period, or during any extension thereof
For its near-term THX-TS01 development program and the longer term THK-ULD01 program targeted to MCI, Therapix is pursuing a 505 (b)(2) regulatory strategy for FDA approval.
Therapix is also developing unique cannabinoid delivery technologies to improve drug administration, including nasal and sublingual delivery methods for THC, with formulations designed to increase efficacy compared with standard oral administration.
Approvals for indications such as TS and MCI may lead to applications in several additional therapeutic indications, including pain, cancer, anti-inﬂammatory, dermatology, and psychiatric disorders.