About Therapix Biosciences — Company Overview
Therapix Biosciences Ltd. (NASDAQ: TRPX; TASE: THXBY) is an emerging specialty pharmaceutical company which develops unique cannabinoid technologies for the 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 Therapix that its request cannot be granted at this time, and is being held in abeyance until and subject to the company providing the FDA with additional information pertaining to the overall prevalence of TS in both children and adults, and further clinical data to support Therapix’s scientific rationale for its request for orphan drug designation within 12 months. Therapix intends 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 via ingestion.
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.