Research and Development

THX-ULD01: Ultra-Low Dose THC to Improve Cognitive Abilities 

Therapix is devel­oping THX-ULD01, a new, ultra-low dose formu­la­tion of dronabinol, combined with sublin­gual and nasal delivery methods, to provide a treat­ment for Mild Cognitive Impairment (MCI). MCI is a pre-Alzheimer’s condi­tion associ­ated with problems with memory, language, thinking and judge­ment. MCI is a widespread condi­tion that increases with age at a rate of 10% among 70–79 year-olds and 25% among 80–89 year-olds. There is no FDA approved treat­ment for MCI.

Therapix has compelling preclin­ical animal data demon­strating that ultra-low dose dronabinol improves cogni­tive abili­ties. Recent studies have found that an ultra-low dose of THC protects the brain from long-term cogni­tive impair­ment which may be caused by lack of oxygen supply, seizures or use of drugs. Studies also suggest that ultra-low doses of THC cause animals to improve perfor­mance in behav­ioral tests that measure learning and memory.

Therapix plans to initiate a prospec­tive, open label, random­ized Phase IIa clinical trial to evaluate the safety, toler­a­bility and efficacy of THX-ULD01 in treating patients with cogni­tive impair­ment. The primary efficacy endpoint of this trial will be change from baseline to end of 6-weeks in the Computerized Neurocognitive Battery, or CNB. CNB measures the perfor­mance, accuracy and speed of specific neurobe­hav­ioral domains using previ­ously validated tests. Secondary efficacy end points will demon­strate safety and toler­a­bility of THX-ULD01 and evaluate the benefit of THX-ULD01 on patient mood, anxiety and overall quality of life using the Hamilton scale.