Italian CNS-focused drug developer Newron Pharmaceuticals (SIX: NWRN) saw its shares gain 6.9% to 1.55 Swiss francs this morning, after it announced encouraging interim results from the first 100 patients in its world-first, international, six-week, open-label, randomized, rater-blinded, multicenter study of evenamide as an add-on to an antipsychotic in patients with moderate to severe treatment-resistant schizophrenia (TRS) who were not responding to current antipsychotic medication.
The results, presented at the 33rd Collegium Internationale Neuro-Psychopharmacologicum (CINP) Hybrid World Congress of Neuropsychopharmacology, in Taipei, Taiwan, show that the addition of evenamide (7.5/15/30mg bid) improved symptoms of psychosis in patients with chronic TRS, reflected by an approximately 12% reduction in the PANSS score, CGI-S improvement of 0.7, and CGI-C ratings indicating 77% of patients responded to the treatment.
The first 100 patients were mostly treated with the 7.5mg and 15mg bid doses, as patients were initially randomized to treatment with these doses; an Independent Safety Monitoring Board reviewed the safety data from the first 50 patients completing the trial prior to allowing randomization to the 30mg bid dose.
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