Therapix (NASDAQ:TRPX) recently underwent an IPO on NASDAQ in the US of 2.3m ADS (worth $13.8m) to finance the clinical development of cannabinoid products. The lead clinical program, THX-TS01, is a combination of THC, the primary active ingredient in cannabis, and palmitoylethanolamide, a molecule generally regarded as safe, which is approved for use as a health supplement in some parts of Europe and Canada. THX-TS01 is currently in Phase II trials testing its potential for treating Tourette’s in adults.
Therapix also has a preclinical program, dubbed THX-ULD01, seeking to treat mild cognitive impairment (MCI) using ultra-low dose THC, which is scheduled to begin Phase I trials in late Q217 or Q317. Both programs should qualify for a 505(b)(2) pathway to streamline their approval processes.
THX-TS01: A potential Tourette’s treatment
According to the National Institute of Neurological Disorders and Stroke, 200,000 people in the US suffer from Tourette Syndrome, approximately one-third of whom are adults, which qualifies the program for an orphan drug designation from the FDA. THC has previously shown potential for movement disorders and independent pilot studies in Tourette’s have been promising. Therapix expects to complete the single-arm, open-label Phase IIa trials currently underway at Yale University in Q317. It also recently announced that an investigator sponsored Phase II placebo controlled crossover study would commence at Hannover Medical School in Q317.
THX-ULD01: Easing cognitive decline
MCI is a symptom cluster that can afflict patients with early Alzheimer’s disease, hypoxia or traumatic brain injury, among others. Therapix is investigating THX-ULD01 as a treatment primarily for MCI using an ultra-low dose of THC. Phase I results are expected in H217, which should enable initiation of a Phase II clinical study around the end of the year.
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