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.