Therapix Biosciences Ltd. (NASDAQ: TRPX) is headquartered in Tel Aviv, Israel, with 9 full-time employees (9/30/2018). It is an emerging specialty pharmaceutical company that develops unique cannabinoid technology to treat central nervous system (CNS) disorders (disorders) ,disease).
Therapix Biosciences (TRPX):
Therapix is engaged in two drug development programs based on the FDA reapproved synthetic cannabinoid (dronabinol):
- Joint Pharma (or: THX-TS01)-used to treat symptoms related to Tourette Syndrome (TS);
- BrainBright Pharma (or: THX-ULD01)-for the high-value and underserved market for mild cognitive impairment (MCI).
Therapix Biosciences has submitted an orphan drug designation for the treatment of Tourette Syndrome (TS) for Joint Pharma, which provides a 7-year exclusive marketing period in the United States. Therapix also intends to seek orphan drug designation from Joint Pharma in Europe.
However, the FDA notified Therapix in a letter dated September 29, 2016 that the company’s request could not be approved at this time and was temporarily shelved until Therapix provided the FDA with additional information on the overall prevalence of TS in children and adults, and further The clinical data supports the scientific basis for its request for orphan drug application within 12 months. The company plans to respond within 12 months or during any extension period.
For the recent Joint Pharma TS development plan and the long-term BrainBright Pharma plan for MCI, Therapix is seeking approval through FDA 505 (b)(2).
In addition, Therapix Biosciences has also developed unique cannabinoid delivery technologies to improve drug delivery, including nasal and sublingual delivery methods for THC, and its formulations are designed to increase efficacy compared to standard oral administration.
Approval of indications (cannabis treatment) such as TS and MCI may open up the application of a variety of other therapeutic indications, including pain, cancer, anti-inflammatory, skin disease and mental illness.
Therapix Biosciences (TRPX) investment:
Therapix Biosciences Ltd.-Ame (NASDAQ:TRPX) was listed on Nasdaq on 3/22/2017 IPO, with an issue price of US$6, issuing 2 million shares, raising US$12 million, stock code: TRPX.