Newron presents six-month interim data from the first 100 patients randomized in study 014/015 at the 31st European Congress of Psychiatry

pharmafile | March 28, 2023 | News story | Business Services  

Milan, Italy, March 28, 2023, 12:30 pm CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), presented two e-posters at today’s “Schizophrenia and other psychotic disorders” session at the 31st European Congress of Psychiatry, taking place at the Palais des Congrès in Paris, France.


New data suggestive of clinically important response in TRS patients


The first poster presented full results from the cohort of the first 100 patients completing six months/endpoint of treatment with evenamide in study 014/015. Study 014/015 is an international, randomized, open label, rater-blinded study of evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS) not responding to their current antipsychotic medication.


Top-line six-month results from this cohort of patients were announced in January 2023, and top-line one-year results were announced in February 2023.


Key findings and conclusions at six months:

  • Efficacy results based on changes from baseline in the Positive and Negative Syndrome Scale (PANSS) as well as CGI-S showed a statistically significant improvement at six months (p-value < 0.001: paired t-test, LOCF). All other efficacy scales showed gradual and sustained improvement during the same period.
  • The PANSS total score improved by approximately 13 points (16%) compared to baseline; the PANSS responder rate was 39%, more than double compared to week six (16%).
  • Ratings of the Clinical Global Impression of Change (CGI-C) indicated that 85% of the patients experienced at least a minimal improvement; 36% of the patients were rated as much or very much improved; this represents an increase of approximately 10% from week 6.
  • The Clinical Global Impression of Severity (CGI-S) improved (i.e., the disease severity was considered reduced) by 0.9 units from baseline.
  • The addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events, the most frequent were pyrexia (3%) and insomnia (3%). 97% of patients completed six weeks of treatment, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).


This was the first international trial of an antipsychotic new chemical entity (NCE) as an add-on to a single antipsychotic in patients with TRS who were not responding to their current medication. These results suggest a new strategy for the management of TRS patients in the future.


The poster is available at Newron’s website.


New responder definition indicated for TRS


The second poster detailed the characterization of “Responder” in TRS patients based on data from this study.


Key findings and conclusions:


A widely accepted definition of response in patients with TRS treated with a putative antipsychotic added to their background antipsychotic monotherapy is currently not available.


Following a thorough analysis of the results from this first study evaluating the add-on therapy with evenamide in TRS, the aim was to determine a definition of responder that integrated three of the most accepted scales to evaluate patients with schizophrenia worldwide, the PANSS, the CGI-S and the CGI-C.


The following two definitions resulted from that analysis:

  • A “Full responder” was defined as PANSS total score improvement of ≥ 20%; the CGI-C to be at least much improved; CGI-S at least 1-point improvement and at most mildly ill.
  • A “Partial responder” was defined as a PANSS total score improvement of ≥ 15%; the CGI-C rated as any improvement; the CGI-S at least 1-point improvement.


The poster is available at Newron’s website

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