India Pharma Outlook Team | Monday, 13 January 2025
Newron Pharmaceuticals S.p.A, a biopharmaceutical firm dedicated to creating innovative treatments for disorders of the central and peripheral nervous systems, along with Myung In Pharm Co. Ltd. (Myung In Pharm), the foremost CNS-focused pharmaceutical company in South Korea, has announced that they have signed a licensing agreement to develop, produce, and market Newron’s novel modulator of glutamate over-release, evenamide, as an adjunct treatment for treatment-resistant schizophrenia (TRS) and patients with schizophrenia who respond poorly, within South Korea.
Evenamide is the initial novel chemical entity that has shown substantial advantages in this challenging-to-treat patient group, as evidenced by the possibly pivotal phase III study 008A trial, used as an additional treatment alongside second-generation anti-psychotics such as clozapine, in 291 patients with chronic schizophrenia who are poorly responsive. The main endpoint, the Positive and Negative Syndrome Scale (PANSS), along with the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were achieved and demonstrated statistical significance when compared to placebo.
According to the license agreement, Myung In Pharm will provide 10% of the overall patient population to be included in Newron’s forthcoming pivotal phase III clinical trial and will bear the expenses associated with this population. Myung In Pharm’s engagement utilizes its established clinical framework and proficiency in the central nervous system (CNS) domain.