Top-line results from Phase 2B study expected in first quarter of 2025
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,” said Ilise Lombardo, MD, Chief Executive Officer for Noema. “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.”
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 added, “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.” D. Sahin added, “This need underscores the importance of studying medications like NOE-101 with distinct mechanisms of action.”
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.
About NOE-101/basimglurant
NOE-101, or basimglurant, is a potent inhibitor of metabotropic glutamate receptor 5 (mGluR5). It is also currently under clinical investigation for trigeminal neuralgia.
About Tuberous Sclerosis Complex
Tuberous sclerosis complex is a rare genetic multisystem disorder caused by mutations in TSC1 and TSC2 genes. This disorder causes uncontrolled benign tumor growth in vital organs of the body including the brain, skin, heart, eyes, kidneys, and lungs and is the leading cause of genetic epilepsy. Approximately 80,000 people in the US and EU are diagnosed with TSC, and about 60 percent of patients do not respond to current treatment options. Their treatment-resistant seizures are often serious or life threatening.
About Noema Pharma
Noema Pharma is a clinical-stage biotech company advancing a portfolio of transformative therapeutics utilizing first-in-disease approaches targeting orphan and large neuroscience-based indications with high unmet need. Noema has active Phase 2 clinical trials evaluating pain in trigeminal neuralgia, seizures in tuberous sclerosis complex, Tourette Syndrome and vasomotor symptoms due to menopause. Noema was founded by leading venture capital firm Sofinnova Partners and is supported by current investors including Forbion, Gilde Healthcare, Invus, Jeito Capital, Polaris Partners and UPMC Enterprises. Learn more at www.noemapharma.com.
Investor Contact:
Precision AQ
Alex Lobo
212-698-8802
alex.lobo@precisionaq.com