- Evenamide Clinical Trials:
- Study 014/015: Positive final one-year results from a Phase II open-label trial evaluating evenamide as an add-on therapy for treatment-resistant schizophrenia (TRS).
- Significant, sustained improvement in Positive and Negative Syndrome Scale (PANSS) Total, Clinical Global Impression of Severity (CGI-S), and Level of Functioning (LOF).
- Over 70% of patients experienced a clinically important reduction in disease severity.
- 25% of patients achieved “remission,” a first for TRS patients.
- Study 008A: Compelling results from a four-week randomized, double-blind, placebo-controlled study of evenamide as an add-on therapy for chronic schizophrenia.
- Statistically significant multi-domain benefits in PANSS and Clinical Global Impression of Change (CGI-C) ratings.
- Benefits increased over time, suggesting larger and enduring effects during long-term treatment.
- Study 014/015: Positive final one-year results from a Phase II open-label trial evaluating evenamide as an add-on therapy for treatment-resistant schizophrenia (TRS).
- Corporate Developments:
- Newron is working towards initiating a potentially pivotal, multinational, randomized, double-blind, one-year, placebo-controlled study to assess evenamide’s efficacy, safety, and tolerability in TRS patients.
- The company is in the process of securing a value-creating transaction around evenamide, with several indications of interest received.
- An agreement was made for the subscription of up to 2.05 million newly issued shares, valued at up to EUR 15 million, with an institutional investor focused on high-growth biotech and healthcare firms.
These updates highlight Newron’s progress in developing innovative treatments for schizophrenia and their strategic efforts to enhance shareholder value12.