Newron Further Expands Intellectual Property Portfolio for Evenamide with New EU Composition of Matter Patent
Ad hoc announcement pursuant to Art. 53 LR
EP4615820 – “Crystalline Forms of Evenamide” is expected to extend asset exclusivity in EU into 2044
- Evenamide is currently being investigated in Newron’s global ENIGMA-TRS Phase III development program, enrolling at least 1,000 schizophrenia patients with topline results expected in Q4-2026
- Evenamide is a first-in-class glutamate modulator with a novel mechanism of action for patients who do not respond adequately, or are resistant to, existing antipsychotic therapies
- ENIGMA-TRS program aims to establish evenamide as the first approved add-on therapy for treatment resistant schizophrenia (TRS), a patient population with high morbidity and mortality
“This European Patent Office decision is evidence of our comprehensive strategy to continuously strengthen the intellectual property protecting our key assets,” stated
We expect this new patent will extend the exclusivity runway for evenamide, supporting our efforts to maximize its therapeutic and commercial potential. This drug candidate, which is currently progressing through pivotal clinical studies, has the potential to become the first add-on therapy for schizophrenia patients who do not respond adequately, or are resistant to, existing antipsychotic therapies, in our assessment constituting the vast majority of patients suffering from schizophrenia.”
Newron has completed the entry into national phases for counterpart patent applications to EP4615820in all key countries. This new composition of matter patent adds to the current extensive IP protection around evenamide.
About treatment-resistant schizophrenia (TRS)
A significant proportion of patients with schizophrenia show virtually little to no beneficial response to currently available antipsychotic (AP) treatments, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no or inadequate symptom relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. It is estimated that approximately 15% of patients develop TRS from the onset of illness, and about one-third to 50% of patients with schizophrenia overall. Emerging scientific evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of clinical benefit of most typical and atypical antipsychotics, which act primarily on dopamine receptors. These insights underline the need for novel therapeutic approaches that target the underlying glutamatergic dysfunction in schizophrenia, offering hope for patients who currently have limited or no effective treatment options.
About evenamide
Evenamide is a novel, orally available new chemical entity with a unique mechanism of action distinct from all currently marketed antipsychotics. It acts by selectively blocking voltage-gated sodium channels (VGSCs) and exhibits no biological activity at more than 130 other central nervous system (CNS) targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of subtherapeutic doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide meaningful benefits for patients who do not adequately respond to current APs, including those on clozapine. A recent study conducted at
About
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near
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