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.