What's Happening?
Newron Pharmaceuticals has secured up to EUR 38 million in funding to advance its Phase III ENIGMA-TRS program, which focuses on developing evenamide as a potential first add-on therapy for treatment-resistant schizophrenia (TRS). The funding comes from a group of existing and new shareholders from Europe and Asia. This financial boost is expected to support the ongoing pivotal studies, ENIGMA-TRS 1 and 2, which aim to evaluate the efficacy and safety of evenamide as an add-on therapy to current antipsychotics. The studies are anticipated to yield 12-week results by the end of 2026.
Why It's Important?
The development of evenamide represents a significant potential breakthrough in the treatment of schizophrenia, particularly for patients who do not respond to existing
antipsychotic medications. Treatment-resistant schizophrenia affects a substantial portion of the patient population, and current therapies often fail to address the underlying glutamatergic dysfunction. Newron's progress in this area could provide a new therapeutic option, improving outcomes for patients with limited treatment choices. The financial backing also underscores investor confidence in Newron's strategy and the potential market impact of evenamide.
What's Next?
Newron Pharmaceuticals will continue to advance its ENIGMA-TRS Phase III program, with pivotal study results expected by late 2026. The company plans to use the secured funds to extend its operational runway and support the execution of its development program. Positive results from these studies could lead to regulatory submissions and eventual market entry, offering a new treatment option for TRS patients. Stakeholders, including healthcare providers and patients, will be closely watching the outcomes of these trials.
