Report reviews key study results and provides updates on additional studies in development.
Newron Pharmaceuticals announced highlights from the first half of 2023 in its exploration of evenamide as a treatment for treatment-resistant schizophrenia (TRS).
In its report, the company reviewed results from study 014/015—the first international trial of an antipsychotic new chemical entity (NCE) as an add-on therapy to a single antipsychotic in patients with TRS. The study results showed that evenamide was safe and well-tolerated among the participants at all doses, and that there was very low incident of treatment-emergent adverse events.1
Overall, 97% of study 014 participants completed 6 weeks of treatment, and more than 90% of those who completed the treatment chose to continue with the treatment for study 015. The company has presented this data at several international psychiatry conferences, and the data was published in the International Journal of Neuropsychopharmacology in June.1
Newron also announced that it is currently developing follow-up studies evaluating evenamide in patients with TRS and chronic schizophrenia. It is working on initiating study 003—a multinational, randomized, double-blind, 12-week, placebo-controlled study—to further examine the safety, tolerability, and efficacy of evenamide (15/30 mg bid) as an add-on treatment in patients with TRS.1
Evenamide (30 mg bid) is also under evaluation as a treatment for patients with chronic schizophrenia in study 008A—a 4-week, randomized, double-blind, placebo-controlled study. Full results from study 008A are expected to be released in late 2023 or early 2024.1
Read the full H1 2023 report here.
1. Newron announces H1 2023 results and provides R&D update. Newron Pharmaceuticals. News release. August 4, 2023. Accessed August 22, 2023. https://www.newron.com/news-and-media/regulatory-news/newron-announces-h1-2023-results-and-provides-rd-update