BASEL, Switzerland, August 13, 2024 – Noema Pharma AG, a clinical-stage biotech company targeting debilitating neuroscience-based disorders with first-in-disease therapeutic approaches, today announced the completion of enrollment in the GALENE Phase 2B trial, a double-blind, placebo-controlled trial evaluating the efficacy of NOE-101 for seizure control in tuberous sclerosis complex (TSC).
We are pleased to have completed enrollment in our Phase 2B study of NOE-101. NOE-101 has the ability to decrease neuronal excitability with the potential to address important therapeutic needs for patients with TSC with a novel mechanism of action. With the trial fully enrolled, we look forward to reporting top-line data in the first quarter of next year.
Ilise Lombardo, MD
Chief Executive Officer for Noema
TSC is a debilitating disease characterized by serious, life-threatening seizures that have long-term impact on brain development. Since current antiepileptic therapies have limited efficacy and significant side effects with over 60% of patients refractory to current treatments, the need for new treatments remains strong. This need underscores the importance of studying medications like NOE-101 with distinct mechanisms of action.
Dr. Mustafa Sahin, MD
Associate Chief of Research, Department of Neurology; Managing Director, Rosamund Stone Zander Translational Neuroscience Center and Director, Translational Research Program at Boston Children’s Hospital
The Phase 2B GALENE study (NOE-TSC-201) is a multicenter, 30-week randomized, double-blind, placebo controlled, cross-over study evaluating the efficacy and safety of NOE-101 adjunctive to ongoing antiseizure therapy in patients with uncontrolled seizures associated with TSC. The primary endpoint will assess improvement in seizure frequency for the NOE-101 treatment and placebo treatment periods. Patients who complete the GALENE study may continue to a 52-week open-label extension.
Investor Contact:
Precision AQ
Alex Lobo
212-698-8802
alex.lobo@precisionaq.com