Newron Pharmaceuticals S.p.A., a biopharmaceutical company focused on developing innovative therapies for disorders of the central and peripheral nervous system, announced that the European Patent Office (EPO) has granted an additional patent covering its lead drug candidate, evenamide. The newly issued composition of matter patent, EP4615820, covers specific crystalline forms of evenamide, methods for their manufacture, and their therapeutic use. The patent is scheduled to remain in force until 2044.
The decision further reinforces Newron’s intellectual property strategy aimed at strengthening long-term protection for its core pipeline assets. According to the company, national phase entries for corresponding patent applications have already been completed in all key markets, adding another layer to the extensive global IP estate surrounding evenamide.
Commenting on the development, Elena Barbanti, senior director of intellectual property at Newron, said the EPO decision validates the company’s ongoing efforts to continuously enhance protection around its most important programmes. Chief executive officer Stefan Weber described the patent grant as a significant milestone, noting that it is expected to extend the commercial exclusivity runway for evenamide as it advances through pivotal clinical development.
Evenamide is currently being evaluated as a potential add-on therapy for patients with schizophrenia who respond inadequately to existing antipsychotic treatments or are considered treatment resistant. A substantial proportion of people living with schizophrenia fall into this category, highlighting a significant unmet medical need.
Treatment-resistant schizophrenia is typically defined as inadequate symptom control despite trials with at least two antipsychotics from different classes at therapeutic doses. Estimates suggest that up to one-third, and potentially as many as half, of all schizophrenia patients may experience limited benefit from currently available therapies. Emerging evidence indicates that abnormalities in glutamate neurotransmission, rather than dopamine alone, play a key role in these patients, underscoring the need for new treatment approaches.
Evenamide is a novel, orally administered small molecule with a mechanism of action distinct from marketed antipsychotics. It selectively blocks voltage-gated sodium channels, thereby normalising pathological glutamate release without affecting baseline neurotransmission. Preclinical studies suggest that evenamide may work synergistically with existing antipsychotics, including clozapine, and could offer sustained benefits through effects on neural plasticity.
Headquartered near Milan, Italy, Newron has a long-standing focus on neuroscience and a track record of advancing innovative CNS therapies. The company believes evenamide has the potential to become the first add-on treatment specifically addressing the needs of patients with treatment-resistant or poorly responsive schizophrenia.
