Newron’s programme for treatment-resistant schizophrenia therapy approved
Ella Day | May 13, 2025 | News story | Research and Development | Newron, Psychiatry, clinical trials, psychiatry, schizophrenia
Newron Pharmaceuticals has announced the approval for its ENIGMA-TRS phase 3 development programme evaluating evenamide as an add-on therapy to current antipsychotics in patients with treatment-resistant schizophrenia (TRS). This is a significant milestone Newron’s endeavour to rollout the therapy as a conventional treatment for these patients.
The ENIGMA-TRS phase 3 development programme consists of two studies, ENIGMA-TRS 1 and ENIGMA-TRS 2. TRS-1 will evaluate the efficacy, tolerability and safety of therapeutic doses of evenamide on patients taking second-generation antipsychotics. Enrolment will start immediately and the trial will take place in centres in Europe, Asia, Latin America and Canada. Recently approved by the US Food and Drug Administration, TRS-2 will conduct a similar assessment in centres in the US, starting in the summer of 2025.
The approval is supported by results from previous clinical studies conducted by Newron that demonstrated the increasing efficacy of evenamide as an add-on therapy on multiple measures of psychopathology.
“The positive results of evenamide observed in clinical studies have led to high enthusiasm in investigators to participate in this landmark programme,” commented Ravi Anand, chief medical officer of Newron.
Since the majority of patients suffering from schizophrenia are treatment-resistant or experience worsened symptoms with treatment, there is a pressing need for more effective treatment for schizophrenic patients. Stephen Marder, director at UCLA Neuropsychiatric Institute, commented that the programme is “a significant milestone in the search for new medications” and that “the field of psychiatry eagerly looks forward” to its results.
Ella Day
13/5/25
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