Newron Pharmaceuticals S.p.A, a biopharmaceutical company specializing in therapies for central and peripheral nervous system diseases, has announced a partnership with South Korea's leading CNS pharmaceutical firm, Myung In Pharm Co. Ltd. The license agreement paves the way for the development, manufacturing, and commercialization of Newron’s breakthrough schizophrenia treatment, evenamide, in South Korea.

Evenamide is a novel modulator targeting the excessive release of glutamate and offers new hope for patients with treatment-resistant schizophrenia (TRS) and those who poorly respond to current therapies. The therapy demonstrated significant benefits in a phase III clinical trial (study 008A), showing improvements in the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impressions Scale – Severity (CGI-S). Importantly, evenamide was well-tolerated and free from typical side effects associated with existing antipsychotics.

Under the agreement, Myung In Pharm will enroll 10% of the patients in Newron’s upcoming pivotal phase III trial, set to begin in the first half of 2025. This randomized, double-blind study will involve at least 600 patients with TRS, comparing evenamide to placebo as an add-on therapy. Myung In Pharm will also handle regulatory, marketing, and commercialization efforts in South Korea, bearing a share of global development costs. Newron will receive upfront and milestone payments, alongside royalties on net sales.

“This partnership marks a significant step in our mission to transform treatment for patients with schizophrenia,” said Stefan Weber, CEO of Newron Pharmaceuticals. “Myung In Pharm’s expertise and robust clinical network will play a critical role in advancing evenamide’s development, ensuring this innovative therapy reaches patients in need.”

Hang Myung Lee, Chairman of Myung In Pharm, expressed enthusiasm for the collaboration: “We are honored to bring evenamide to South Korea, addressing the significant unmet needs in schizophrenia treatment. Our clinical capabilities and market leadership in CNS therapies align perfectly with Newron’s groundbreaking approach, and we are excited to contribute to the success of this promising therapy.”

Schizophrenia affects approximately 25 million people globally, including over 210,000 in South Korea, according to the Health Insurance Review & Assessment Service (HIRA). Despite the availability of over 60 antipsychotic medications, a significant portion of patients—30-50%—remain treatment-resistant. An additional 20-30% are considered poor responders to existing therapies. Emerging research highlights the role of abnormalities in the glutamatergic system among TRS patients, underscoring the urgent need for innovative treatments like evenamide.

This agreement follows a similar partnership between Newron and EA Pharma, a subsidiary of Eisai Co., Ltd., announced in December 2024 for evenamide’s development in Japan and other Asian territories. These collaborations reflect Newron’s commitment to addressing global gaps in schizophrenia treatment and advancing its position as a leader in CNS therapeutic innovation.