Newron Secures Up to EUR 38 Million to Advance Phase III Evenamide Program
Ad hoc announcement pursuant to Art. 53 LR
Proceeds expected to fund global ENIGMA-TRS studies and extend cash runway beyond pivotal 12-week results, supporting development of evenamide as the potential first add-on therapy for treatment-resistant schizophrenia
Under the agreement, the investor group will initially subscribe to up to 779,624 newly issued shares at a subscription price of
“The investment by this group of existing and new shareholders is further validation of our development strategy for evenamide as the potential first add-on therapy in schizophrenia and as a new treatment option for the vast majority of patients who are poorly responding or resistant to available treatment options,”
said
The initial up to 779,624 newly issued shares are expected to be listed and traded on the
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The total number of shares to be issued under the Transaction will depend on the share price at the time of execution of the additional tranches. Applying the subscription price of the initial tranche, Newron would issue up to 1,971,052 shares. |
About ENIGMA-TRS
The ENIGMA-TRS pivotal Phase III program consists of ENIGMA-TRS 1 and ENIGMA-TRS 2. ENIGMA-TRS 1, initiated in
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. Importantly, the benefits seemed to persist for a substantial time after evenamide had been degraded, explaining the long-term effects seen in clinical studies. Through its novel glutamatergic modulation, evenamide represents a first-in-class approach aimed at addressing the unmet needs of patients with schizophrenia who are resistant to existing treatments.
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
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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