Newron Pharmaceuticals S.p.A., a biopharmaceutical company focused on novel treatments for nervous system disorders, has entered into a licensing agreement with Myung In Pharm Co. Ltd., South Korea's leading CNS-focused pharmaceutical company. This partnership aims to develop, produce, and commercialize evenamide, a promising therapy for treatment-resistant schizophrenia (TRS) and poorly responsive schizophrenia patients in South Korea.
Stefan Weber, CEO of Newron, expressed enthusiasm about the collaboration, highlighting Myung In Pharm's expertise in CNS therapies and clinical infrastructure as key factors in advancing evenamide's development. Myung In Pharm will contribute 10% of the patients for Newron's upcoming Phase III clinical trial, covering the associated costs for this group. The company will also share a portion of the global development expenses and manage regulatory, registration, marketing, and commercialization activities for evenamide in South Korea.
The Phase III trial, scheduled to start in the first half of 2025, will involve at least 600 TRS patients in a year-long, double-masked, randomized study comparing evenamide to a placebo as an add-on therapy. Newron will oversee the trial design, execution, and data analysis, while Myung In Pharm will recruit patients through its clinical network and support monitoring and data collection in South Korea.
This collaboration follows Newron's recent partnership with EA Pharma to bring evenamide to Japan and other Asian territories, marking a significant step in expanding the treatment's impact in the region.