Abide Therapeutics has started its Phase II clinical trial to examine the efficacy, safety, tolerability, and dosing regimen of ABX-1431 in treating Tourette syndrome (TS).
TS is a neurodevelopmental disorder that causes sudden, involuntary movements and vocal tics.
As part of the multicentre, double-blind, randomised trial, Abide is expected to include up to 48 adult patients with TS or chronic motor tic disorder (CMTD).
Patients will receive a daily dose of ABX-1431, an investigational monoacylglycerol lipase (MGLL) inhibitor, for up to eight weeks.
The placebo-controlled trial also includes an open-label extension arm for an additional period of four weeks.
The trial's primary goal is the change from baseline in total tic score of the Yale Global Tic Severity Scale (YGTSS) compared with placebo.
The trial will measure the patient’s premonitory urge preceding tics. It will also investigate the potential impact of ABX-1431 on additional psychological problems associated with TS, such as attention-deficit hyperactivity disorder, obsessive-compulsive disorder, anxiety, and depression.
Abide Therapeutics CEO and president Alan Ezekowitz said: “The results of our initial Tourette trial indicated that selective modulation of endocannabinoid tone in overactive circuits by oral administration of ABX-1431 has the potential to treat the whole patient, beginning with blunting the urge that drives the need to tic, and may affect common co-morbid conditions like anxiety and obsessive-compulsive disorder.
“This, together with the tolerability profile of ABX-1431, supports the further development of ABX-1431 in Tourette Syndrome.”
The trial's first patient has already been dosed.