Noema Pharma AG has announced the dosing of the first patients in its Phase 2b clinical trial, NOE-TTS-201 (NCT06315751), evaluating gemlapodect (NOE-105) for the treatment of Tourette Syndrome. This global study aims to assess the safety and efficacy of gemlapodect, a potential first-in-class phosphodiesterase-10A (PDE10A) inhibitor, in reducing the severity of tics associated with Tourette Syndrome.
The Phase 2b trial is a 12-week, randomized, double-blind, placebo-controlled study designed to enroll 140 patients with Tourette Syndrome across multiple centers in the US and Europe. Participants will receive up to 15 mg of gemlapodect once daily or a matching placebo. The primary endpoint is the Yale Global Tic Severity Scale (YGTSS) Total Tic Score, a widely used measure for assessing tic severity in Tourette Syndrome.
Rationale for Gemlapodect
Gemlapodect (NOE-105) is being developed as a dopamine modulator for Tourette Syndrome. It is designed to selectively inhibit phosphodiesterase-10A (PDE10A), an enzyme that plays a role in dopamine signaling within the medium spiny neurons of the striatum. This targeted approach aims to reduce motor and vocal tics while minimizing off-target effects often associated with other dopamine antagonists.
Tourette Syndrome: An Unmet Need
Tourette Syndrome is a neurodevelopmental disorder characterized by motor and vocal tics, often preceded by urges or premonitory sensations. It affects over half a million individuals and families in the US alone, and millions worldwide. Current treatment options are limited, and many patients continue to experience a significant burden related to their tics.
Clinical Development and Future Outlook
"Patients with Tourette syndrome carry an incredible burden related to the expression of motor and vocal tics with limited treatment options," said Ilise Lombardo, M.D., Chief Executive Officer of Noema Pharma. "I am happy to announce the progression of the development of gemlapodect in Tourette syndrome with the dosing of the first patients in our Phase 2b trial."
Noema Pharma anticipates readouts from its Phase 2 clinical trials, including the gemlapodect trial for Tourette Syndrome, in 2025. These results are expected to provide critical insights into the potential of gemlapodect as a novel treatment option for individuals with Tourette Syndrome.
