Evenamide (NW-3509): Advancing Solutions for Treatment-Resistant Schizophrenia

• Evenamide (NW-3509)– derived from Newron’s ion channel program, tackles schizophrenia with its unique mechanism, balancing glutamate levels and blocking aberrant sodium channel activity to restore neuronal function without compromising normal excitability.
• Evenamide, based on a new concept in treating inadequate/non-response in schizophrenia, enhances the effects of antipsychotic medications by synergistically targeting glutamate and dopamine systems, thereby optimizing the therapeutic approach. 

Newron Pharmaceuticals’ poster featuring their drug candidate, evenamide (NW-3509), was presented at the Congress of the Schizophrenia International Research Society (SIRS) in Florence, Italy, held from April 3^rd to 7^th, 2024. The poster showcased findings from a potentially crucial Phase II/III trial, conducted internationally and randomized, double-blind, and placebo-controlled, targeting patients with inadequate response to their current antipsychotic medication.

Unmet needs in the current regime persist despite advancements in pharmacotherapy. One significant challenge is the inadequate response to antipsychotic medications experienced by a subset of patients, often referred to as treatment-resistant schizophrenia. TRS patients continue to struggle with persistent symptoms despite receiving multiple trials of different antipsychotic medications at adequate doses and durations. This lack of response not only exacerbates the burden of illness but also increases the risk of relapse, hospitalization, and functional impairment.

These limitations underscore the urgent need for novel therapeutic approaches like Newron Pharmaceuticals’ evenamide (NW-3509), which offers a unique mechanism of action that complements existing antipsychotics by selectively inhibiting voltage-gated sodium channels, potentially addressing the underlying pathophysiology contributing to treatment resistance.

Newron presented compelling findings at the SIRS conference in Italy regarding the efficacy of evenamide (NW-3509) as an adjunctive therapy for treatment-resistant schizophrenia (TRS) patients. The study demonstrated that the addition of evenamide to antipsychotics was well-tolerated, with a low incidence of adverse events. Patients treated with evenamide experienced sustained and clinically significant benefits throughout the 1-year treatment period, showing gradual and continuous improvement across various efficacy measures. Notably, over 70% of patients exhibited a clinically important reduction in disease severity, with approximately half no longer meeting the criteria for treatment resistance after 1 year.Furthermore, 25% of patients achieved remission, a milestone previously unreported in TRS patients, and no patient experienced relapse during the treatment period, representing a transformative opportunity in schizophrenia management.

These findings suggest evenamide’s potential as a promising option for TRS patients, offering improved symptom control, increased treatment response rates, and the possibility of achieving remission. Additionally, Newron’s ongoing investigation of evenamide in chronic schizophrenia patients who have an inadequate response to current antipsychotic treatment represents a further step towards addressing unmet needs in schizophrenia management, potentially providing new hope for patients facing treatment challenges.

The Phase II/III trial presented by Newron Pharmaceuticals showed promising results, indicating that evenamide, as an adjunctive therapy, can lead to sustained and clinically significant benefits for TRS patients, by providing a new avenue for symptom control, and increased treatment response rates. Evenamide has the potential to significantly improve the lives of individuals grappling with the debilitating effects of schizophrenia.

In conclusion, the emergence of Evenamide (NW-3509) presents a ray of opportunity in the often challenging landscape of schizophrenia treatment. Its novel mechanism of action, coupled with its ability to enhance the efficacy of existing antipsychotics, signifies a promising shift toward addressing the unmet needs of patients with treatment-resistant schizophrenia. Moreover, Newron Pharmaceuticals’ strategic approach to market access, leveraging early exclusivity until 2033 and subsequent post-approval exclusivity in the EU, positions Evenamide as a frontrunner in the evolving schizophrenia treatment market. This unique advantage not only enhances its commercial viability but also underscores its potential to reach patients in need expeditiously.