Noema Pharma Completes Enrollment for GALENE Phase 2B Trial on NOE-101 for Seizure Control in Tuberous Sclerosis Complex

Noema Pharma AG, a clinical-stage biotechnology company located in Basel, Switzerland, has recently announced the completion of patient enrollment in its GALENE Phase 2B trial. This trial is a double-blind, placebo-controlled study designed to evaluate the effectiveness of NOE-101 in controlling seizures in patients with tuberous sclerosis complex (TSC).

Ilise Lombardo, MD, the Chief Executive Officer of Noema Pharma, expressed satisfaction with the completion of this critical enrollment phase. She explained that NOE-101 has the potential to decrease neuronal excitability, offering a novel therapeutic approach for patients with TSC. With the trial now fully enrolled, the company anticipates releasing top-line results in the first quarter of 2025.

Dr. Mustafa Sahin, MD, who serves as the Associate Chief of Research in the Department of Neurology and as the Managing Director of both the Rosamund Stone Zander Translational Neuroscience Center and the Translational Research Program at Boston Children's Hospital, emphasized the importance of this research. Dr. Sahin pointed out that TSC is a severe disease characterized by life-threatening seizures that significantly impact brain development. Current antiepileptic treatments have limited efficacy and come with considerable side effects, leaving over 60% of patients without effective solutions. NOE-101, with its unique mechanism of action, could fulfill a critical need for these patients.

The GALENE Phase 2B study, also known as NOE-TSC-201, is a multicenter, 30-week randomized trial. It employs a double-blind, placebo-controlled, cross-over design to assess both the efficacy and safety of NOE-101 as an adjunctive treatment to existing antiseizure therapies in patients whose seizures are not well-controlled. The primary endpoint of the study will measure changes in seizure frequency during both the NOE-101 treatment and placebo periods. Participants who successfully complete this study may opt to join a 52-week open-label extension for further evaluation.

NOE-101, also known as basimglurant, is a powerful inhibitor of the metabotropic glutamate receptor 5 (mGluR5). This compound is also undergoing clinical trials for trigeminal neuralgia, another condition with significant unmet medical needs.

Tuberous sclerosis complex is a rare genetic condition caused by mutations in the TSC1 and TSC2 genes. This disorder leads to the uncontrolled growth of benign tumors in critical organs such as the brain, skin, heart, eyes, kidneys, and lungs. TSC is the leading genetic cause of epilepsy. Approximately 80,000 individuals in the United States and the European Union are diagnosed with TSC, and about 60% of these patients do not respond to existing treatment options, often suffering from severe or life-threatening seizures.

Noema Pharma is dedicated to developing innovative treatments for neurological disorders with significant unmet medical needs. The company currently has several Phase 2 clinical trials underway, targeting conditions such as pain in trigeminal neuralgia, seizures in tuberous sclerosis complex, Tourette syndrome, and vasomotor symptoms related to menopause. Founded by the venture capital firm Sofinnova Partners, Noema Pharma is supported by investors like Forbion, Gilde Healthcare, Invus, Jeito Capital, Polaris Partners, and UPMC Enterprises.