Newron Pharmaceuticals S.p.A. has entered into a license agreement with EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd., to develop, manufacture, and commercialize Newron’s innovative glutamate modulator, evenamide, for the treatment of schizophrenia in Japan and other Asian territories. The agreement includes a payment structure of up to €117 million, which consists of an upfront payment of €44 million, contributions to an upcoming Phase III study, regulatory and commercialization milestones, and tiered royalties based on net sales.
This agreement marks a significant milestone for Newron, with the €44 million upfront payment expected to have a substantial impact on the company’s 2024 financial results. Stefan Weber, CEO of Newron, expressed excitement about partnering with EA Pharma to bring evenamide to patients with schizophrenia, especially those who are treatment-resistant or poorly responsive to current therapies. He emphasized that Newron’s focus will now shift toward initiating a Phase III one-year study for treatment-resistant schizophrenia (TRS) outside the licensed territories in H1 2025, with the aim of submitting regulatory filings in Japan and other Asian regions.
EA Pharma’s President, Hidenori Yabune, praised evenamide for its novel mechanism of action in regulating glutamate, a neurotransmitter involved in schizophrenia. Yabune believes that evenamide has the potential to transform the treatment landscape for patients suffering from schizophrenia, particularly those who do not respond to existing antipsychotic medications.
Schizophrenia affects around 25 million people globally, with a significant portion of patients not responding to available treatments. About 30-50% of patients are categorized as treatment-resistant, and another 20-30% show poor response to antipsychotics. Research has revealed abnormalities in the glutamatergic system in treatment-resistant patients, indicating a pressing need for therapies targeting this mechanism.
Evenamide represents a potential breakthrough in this field. It is the first new chemical entity to demonstrate efficacy in treatment-resistant patients with schizophrenia, as shown in the Phase III study 008A. In this study, evenamide was tested as an add-on therapy to second-generation antipsychotics, including clozapine, in 291 patients with chronic schizophrenia who were not adequately responding to their current medications. The results demonstrated that evenamide significantly improved both primary and secondary endpoints, including the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impressions Scale – Severity (CGI-S), with a substantial portion of patients experiencing meaningful clinical benefits. Notably, evenamide was well-tolerated, with minimal side effects compared to typical antipsychotics.
Newron has also reported promising data from the Phase II trials, including a one-year open-label study (014/015), where evenamide showed sustained, clinically significant benefits. The trial demonstrated that over 70% of patients experienced significant reductions in disease severity, and the treatment was well tolerated with a low incidence of adverse events. These positive results from various trials have established evenamide as the first glutamate modulator to show efficacy in treatment-resistant schizophrenia in placebo-controlled studies.
Looking ahead, Newron plans to initiate a Phase III randomized, double-blind trial in H1 2025 to evaluate evenamide in 600 patients with TRS. This trial will measure the efficacy of evenamide as an add-on treatment and assess its long-term safety, efficacy, and tolerability.
Newron Pharmaceuticals, headquartered in Bresso, Italy, is focused on developing novel therapies for central and peripheral nervous system diseases. The company’s existing product, Xadago® (safinamide), is approved for Parkinson’s disease in several markets, and Newron is actively pursuing further development of evenamide for schizophrenia. EA Pharma, established in 2016, is a specialty pharmaceutical company in Japan, with a long history of research and development in the gastrointestinal and neurological fields.
Through this agreement, Newron and EA Pharma aim to bring a new treatment option to patients in need, offering hope for those suffering from schizophrenia who have not found relief with current therapies.
