Newron has expanded the intellectual property protection for its lead development asset evenamide after the European Patent Office granted a new composition of matter patent covering crystalline forms of the compound.

The patent, EP4615820, is expected to extend exclusivity for evenamide in the EU until 2044 and adds to the company’s existing intellectual property estate around the programme. The patent claims crystalline forms of evenamide, processes for their preparation and their uses, strengthening protection as the asset progresses through late-stage development.

Evenamide is currently being evaluated in Newron’s global Enigma-trs Phase 3 clinical development programme in treatment resistant schizophrenia. The study is enrolling at least 1,000 patients, with topline data expected in Q4 2026.

Newron said the additional patent supports its strategy of building layered intellectual property protection around evenamide as it advances through clinical development and towards potential commercialisation. The company has also completed entry into national phases for counterpart patent applications to EP4615820 in all key countries.

Elena Barbanti, senior director intellectual property at Newron, said the decision reflected a long-term approach to protecting the company’s pipeline: “This European Patent Office decision is evidence of our comprehensive strategy to continuously strengthen the intellectual property protecting our key assets.”

Evenamide is a first-in-class glutamate modulator with a novel mechanism of action that differentiates it from currently approved antipsychotic therapies. The compound is being developed as a potential add-on therapy for patients with schizophrenia who do not respond adequately, or are resistant to, existing antipsychotic treatments.

Stefan Weber, ceo of Newron, added that the patent milestone supports both the clinical and commercial outlook for the programme. “This is an important milestone for Newron and a testament to the outstanding work of our IP team,” Weber said. “We expect this new patent will extend the exclusivity runway for evenamide, supporting our efforts to maximise its therapeutic and commercial potential.”

Treatment resistant schizophrenia remains an area of high unmet medical need. A significant proportion of patients show little or no meaningful response to currently available antipsychotic drugs, despite treatment with multiple therapies. Estimates suggest that around 15% of patients develop treatment resistance from disease onset, while up to half of patients with schizophrenia may experience treatment resistance at some point during their illness.

Emerging scientific evidence points to abnormalities in glutamate neurotransmission in treatment resistant schizophrenia, alongside relatively normal dopaminergic synthesis. This may help explain why existing antipsychotics, which primarily target dopamine receptors, fail to deliver adequate clinical benefit for many patients.

Evenamide is an orally available new chemical entity with a unique mechanism of action distinct from marketed antipsychotics. It selectively blocks voltage-gated sodium channels and has shown no biological activity across more than 130 other central nervous system targets. Preclinical and translational studies suggest the compound normalises aberrant glutamate release without affecting basal glutamate levels.

Newron said the Enigma-trs programme is designed to establish evenamide as the first approved add-on therapy for treatment resistant schizophrenia, a patient population associated with high morbidity and mortality and limited therapeutic options.