Newron's Evenamide Shows Promise in Treatment-Resistant Schizophrenia
Key Insights
Newron Pharmaceuticals (search) reported positive results for evenamide in treatment-resistant schizophrenia (search) (TRS) from Phase II trials, demonstrating significant improvements in symptoms.
Study 008A showed statistically significant benefits in PANSS and CGI-C ratings, suggesting potential for larger, enduring effects with long-term use of evenamide.
Newron is advancing evenamide to a Phase III trial, expected to begin in H1 2025, to further assess its efficacy and safety as an add-on treatment for TRS.
Newron Pharmaceuticals (search) has announced positive results from its Phase II trials of evenamide as an add-on therapy for treatment-resistant schizophrenia (search) (TRS) and chronic schizophrenia. The data suggest that evenamide, a novel glutamatergic modulator, could offer a new therapeutic option for patients who do not benefit adequately from current antipsychotic treatments.
Evenamide Clinical Trial Results
Study 014/015, an open-label Phase II trial, demonstrated that evenamide, when added to a single antipsychotic, led to significant and sustained improvements in patients with TRS. Key findings included:
- Significant improvement in Positive and Negative Syndrome Scale (PANSS) Total score.
- Clinically important reduction in disease severity in over 70% of patients.
- Remission achieved in 25% of patients, a result not previously observed in TRS patients.
Study 008A, a four-week randomized, double-blind, placebo-controlled trial, evaluated evenamide as an add-on therapy in patients with chronic schizophrenia (search) who had inadequate benefit from their current second-generation antipsychotic. The study revealed statistically significant multi-domain benefits in PANSS and Clinical Global Impression of Change (CGI-C) ratings. Notably, the benefits on efficacy measures increased over time, suggesting the potential for larger and more enduring patient effects with long-term treatment.
Safety and Tolerability
Both studies confirmed evenamide's favorable safety and tolerability profile. In study 014/015, 97% of patients completed six weeks of treatment, and the incidence of treatment-emergent adverse events was very low. Similarly, study 008A reported a high study completion rate (96%) with no new or specific safety concerns raised; the incidence of adverse events was similar between the evenamide and placebo groups (25% vs. 25.8%).
Upcoming Phase III Trial
Newron is planning to initiate a potentially pivotal, multinational, randomized, double-blind, one-year, placebo-controlled Phase III study in the first half of 2025. This trial will assess the efficacy, safety, and tolerability of evenamide as an add-on treatment in at least 400 patients with TRS. The study design has received regulatory approval in relevant territories, and discussions are ongoing with the FDA regarding the dosing regimen.
Strategic Partnerships and Financial Outlook
Newron is actively seeking a value-creating transaction for evenamide, such as a regional or global license, or a merger and acquisition (M&A) transaction. The company has engaged a leading healthcare investment bank to support this process. Recent financial activities include an agreement with the European Investment Bank to extend repayment dates and an agreement for the subscription of newly issued shares with an institutional investor, providing funds to support the Phase III development of evenamide.
Xadago/Safinamide Update
Newron, in partnership with Zambon (search) and Supernus (search), continues to develop and market Xadago/safinamide for Parkinson’s disease (search). Settlement agreements have been reached with generic manufacturers, allowing them to enter the US market with a safinamide mesylate drug product no earlier than December 1, 2027. Supplementary Protection Certificates (SPCs) have been approved in most relevant EU territories.