Noema Pharma Begins Dosing Patients in Phase 2b Study of Gemlapodect for Tourette Syndrome

Noema Pharma AG, a clinical-stage company focused on neuroscience, has initiated a Phase 2b trial to assess the safety and efficacy of gemlapodect (NOE-105) for Tourette syndrome. This study, NOE-TTS-201 (NCT06315751), is a 12-week, randomized, double-blind, placebo-controlled trial, involving 140 patients across various centers in the United States and Europe. Participants will receive either up to 15 mg of gemlapodect daily or a placebo. The primary measure of the trial's success is the Total Tic Score on the Yale Global Tic Severity Scale (YGTSS).

Tourette syndrome, a neurodevelopmental condition characterized by sudden, involuntary motor and vocal tics, affects over half a million people in the U.S. alone and millions worldwide. The disorder places a significant burden on patients and their families, with limited treatment options available.

Dr. Ilise Lombardo, CEO of Noema Pharma, expressed optimism about the trial's commencement, highlighting the need for new treatments that address the challenges faced by those with Tourette syndrome.

Gemlapodect (NOE-105) is a potential first-in-class inhibitor of phosphodiesterase-10A (PDE10A), currently in mid-stage clinical trials. It acts as a dopamine modulator specifically targeting the medium spiny neurons in the brain's striatum, offering a more focused treatment with fewer side effects compared to other dopamine antagonists. Previous studies have shown that NOE-105 is well-tolerated by both healthy volunteers and patients with Tourette syndrome.

Noema Pharma is a biotech company dedicated to developing transformative treatments for neuroscience-based conditions that have high unmet needs. The company is advancing several programs through Phase 2 clinical trials, targeting conditions such as pain in Trigeminal Neuralgia, seizures in Tuberous Sclerosis Complex, and symptoms associated with menopause. Founded by Sofinnova Partners, Noema Pharma receives support from investors including Forbion, Gilde Healthcare, Invus, Jeito Capital, Polaris Partners, and UPMC Enterprises. The company anticipates reading out the trial results in 2025.