Therapix bioscience (OTC Pink: TRPXY) develops cannabinoid-based therapies and expected to commence a clinical trial in patients with Tourette Syndrome (TS).
TS is a movement and neurobehavioral disorder characterized by motor and vocal chronic tics with onset before age 18. About half to two-thirds of the cases get much better during adolescence, however adults will generally be more severe patients. Tics may be associated with a premonitory sensation to perform the specific action, which may lead to “relief” once performed. Studies in patients with TS provided evidence of presynaptic dopaminergic dysfunction suggesting an involvement of the dopaminergic system in TS pathology.
Overall, the TS and Chronic Tic Disorder market potentially estimated a $1.5 billion commercial opportunity(1).
Therapix is developing THX-110, an innovative and proprietary drug candidate platform containing THC and CannAmide™(2), for the treatment of Central Nervous System diseases such as movement disorders (TS for example).
Therapix's THX-110, by harnessing the entourage effect phenomenon, described by Prof. Mechoulam, aims to Provide an efficacious treatment with high safety profile.
Therapix believes that the results obtained from its Phase IIa clinical trial conducted in Yale University, Connecticut, USA, show a great promise:
- An average tic reduction of 21% across the entire sample
- Six of the 16 medication-refractory TS subjects experienced a response to treatment as defined by a reduction in YGTSS-TTS of greater than 25%
- Improvement over time with treatment
- The medication was generally well-tolerated by subjects
- Twelve of the 16 subjects elected to continue into a 24-week extension phase of the trial
Tourette Syndrome Phase IIb Clinical Trial. Therapix intends to continue evaluate the efficacy, safety and tolerability of its THX-110with in a randomized, placebo-controlled trial. The study is expected to commence in at least one clinical site in Hanover Medical School, Hanover, Germany.
Patients will be randomized in 1:1 ratio to receive either THX-110 or THC with CannAmideTM matched placebo.
- Analysis based on proprietary consulting engagement conducted by Huron Consulting (2017)
- CannAmide is Therapix proprietary formulation of Palmitoylethanolamide (PEA) designed to increase its solubility and absorption