New treatment option for Tourette Syndrome enters Phase 2 clinical trial

Tourette Syndrome is a common neurodevelopmental disorder that affects 138,000 children in the US alone. It begins in childhood or adolescence, characterized by multiple tics such as blinking, coughing, throat clearing, sniffing, and facial movements. It is most often treated with antipsychotics which come with limited benefit and significant motor and metabolic side effects, including insulin resistance and type 2 diabetes.

Noema Pharma’s NOE-105 is an inhibitor of the enzyme PDE10A and is not associated with the metabolic abnormalities that are typically observed with most second-generation antipsychotics. The Allevia trial is a multi-center 12-week prospective study to evaluate the safety and efficacy of once a day NOE-105. The Allevia trial is expected to report in H1 2022.

“This dose ranging study will help generate useful data to understand the efficacy and safety of NOE-105 in patients with Tourette Syndrome,” said Dr George Garibaldi, Chief Medical Officer of Noema Pharma. “In a neuroimaging study using a PET tracer, the drug has shown a good penetration of the brain and a dose proportional target engagement. This study will further allow us to better understand the efficacy of NOE-105 in patients presenting with comorbidities associated with Tourette’s”.

Noema Pharma is a Swiss-based company targeting orphan CNS diseases characterized by an imbalanced neuronal network. The company has an extensive pipeline of products in-licensed from Roche. Lead product NOE-101, a mGluR5 inhibitor, is Phase 2b ready for persistent seizures in Tuberous Sclerosis Complex (TSC) and severe pain in Trigeminal Neuralgia (TN).

(Press release / SK)