Noema Pharma, a Swiss-based clinical stage company targeting orphan central nervous system (CNS) diseases, today announces the initiation of its first clinical trial, a Phase 2a dose ranging study of the PDE10A inhibitor NOE-105 in Tourette Syndrome.

The Allevia trial is a multi-center 12-week prospective study to evaluate the safety and efficacy of once a day NOE-105, one of Noema’s extensive pipeline of products in-licensed from Roche, at a daily dose range of 5mg to15mg in adult male patients with Tourette Syndrome. NOE-105 has previously been found to be safe in adults at repeated doses up to 30 mg per day. 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”

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. NOE-105 is an inhibitor of PDE10A, an enzyme highly expressed in medium spiny neurons of the mammalian striatum inhibitor, which modulates D2 receptor signaling and is not associated with the metabolic abnormalities that are typically observed with most second-generation antipsychotics.

The international expert Dr Andreas Hartmann, of Sorbonne University, Pitié-Salpêtrière Hospital, Paris, France, will be partnering with principal investigators to conduct an in-depth evaluation of the efficacy and safety of NOE-105 in patients with Tourette. Dr Andreas Hartmann said: “Tourette Syndrome can be a devastating disease, significantly affecting patients’ confidence and ability to go about everyday tasks. There is a substantial unmet medical need because existing treatments have potentially limited benefits and significant drawbacks. The clinical development of NOE-105 offers a possibility to improve this treatment landscape and to bring a greater sense of normality back to patients’ lives.”

Principal investigator Philip E Mosley, of the Wesley Medical Research Institute, Auchenflower, Australia, said: “I am pleased to play a role in the development of new and innovative treatments for Tourette syndrome and that our Institute has been selected as one with particular expertise in the evaluation and treatment of those with this condition.”

Principal investigator Andrew Evans, of the Royal Melbourne Hospital, Australia, said: “Industry sponsored clinical trials in Tourette Syndrome have been limited in the past, meaning there are very few treatments options for these patients. The commitment of Noema to develop a new treatment, already proven to be safe and with a promising mechanism of action, is exciting and I look forward to contributing to its clinical development.”

About Noema Pharma

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 and with strong safety packages, including lead product NOE-101, a mGluR5 inhibitor, which is Phase 2b ready for persistent seizures in Tuberous Sclerosis Complex (TSC) and severe pain in Trigeminal Neuralgia (TN). NOE-105, a PDE10A inhibitor, is in Phase 2 for the treatment of Tourette Syndrome. Noema Pharma was seeded by the leading European venture capital firm Sofinnova Partners.

About Gilde Healthcare

Gilde Healthcare is a specialized healthcare investor managing over $1.5 billion across two fund strategies: venture & growth capital and private equity. Gilde Healthcare’s venture & growth capital fund invests in fast growing companies active in digital health, medtech and therapeutics. The venture & growth companies are based in Europe and North America. For more information, visit the company’s website at www.gildehealthcare.com.