Newron reports compelling topline results from all patients in Study 014, its Phase II clinical trial evaluating evenamide as add-on therapy for treatment-resistant schizophrenia

pharmafile | March 20, 2023 | News story | Business Services  

Milan, Italy, March 20, 2023, 07:00 am 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), announces exciting topline results from Study 014, a phase II, international, randomized, open label, rater-blinded trial evaluating 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. While the primary objective of the study was safety and tolerability of the drug, efficacy over baseline was also assessed. Interim results from the first 100 patients at six weeks were previously reported in June 2022.


Notably, of the 161 patients who were randomized, 153 (95%) completed the six-week treatment period and 144 (94% of the completers) entered the extension study (Study 015). One patient discontinued treatment due to flu-like symptoms, and seven withdrew consent.


Overall, the results from the complete study population are fully consistent with the findings from the first 100 patients at this timepoint. The mean Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression of Severity (CGI-S) rating, and the Strauss-Carpenter Level of Functioning (LOF) total score significantly improved compared to baseline (p<0.001). The proportion of patients considered “clinically important responders” on the PANSS, the Clinical Global Impression of Change (CGI-C) and the CGI-S was in line with the proportion of the first 100 patients experiencing this level of benefit after six weeks. Mean improvement from baseline was also consistent for the Medication Satisfaction Questionnaire (MSQ) when compared to this measure for the first 100 patients.


The number of patients who experienced treatment-emergent adverse events (TEAEs) was low (26%) and none was rated severe; the most commonly reported TEAEs (≥3%) were dizziness, pyrexia, and CPK increase. No treatment-emergent or clinically important findings for weight gain, metabolic syndrome, sexual dysfunction, neurological findings (based on ESRS-A and neurological examination), standard laboratory tests or electrocardiograms (ECGs) were reported. This adverse event profile was also similar to that seen from the first 100 patients.


Ravi Anand, M.D., Newron’s Chief Medical Officer, said: “The final results of study 014 are exciting for various reasons. Firstly, the results indicate that the last 61 patients to be enrolled in the study share the same demographic and disease improvement characteristics as of the first 100 patients, after six weeks of treatment. Treatment with evenamide at all doses (7.5, 15 or 30 mg bid) was also as well tolerated in the final 61 patients as was shown in the initial cohort of 100 patients, thus confirming the reliability of the data collected in this study.


The tolerability and safety of the doses of evenamide in the last 61 patients was also largely similar to that reported earlier in terms of high completion rate, low discontinuation due to adverse events and very low incidence of adverse events.


Most importantly, the pattern of benefit associated with evenamide in these 61 patients was similar to the efficacy noted in the first 100 patients, without any evidence of systematic differences between doses of evenamide. Additionally, the efficacy benefits of evenamide in the analysis of all 161 patients at six weeks appeared very similar to the findings from the first 100 patients.


We are hopeful that these encouraging results at six weeks from all 161 patients in study 014 will be replicated at six months and one-year timepoints in all patients in study 015. Confirmation of these results in the final analyses would offer new hope to patients with TRS and would further support our plans for the initiation of study 003, a Phase III study in patients with TRS, which we intend to begin later in 2023.”


Detailed results from study 014 will be presented at the 36th European College of Neuropsychopharmacology (ECNP) Congress, taking place 7-10 October 2023 in Barcelona, Spain. In addition, Newron will be presenting the results of the previously announced six-month endpoint from the first 100 patients at the 31st European Congress of Psychiatry taking place 25-28 March 2023, in Paris, France, and the one-year data at the Congress of the Schizophrenia International Research Society taking place 11-15 May 2023, in Toronto, Canada.


Newron expects to initiate a potentially pivotal, multinational, randomized, placebo-controlled trial in patients with TRS (study 003) in 2023, as part of its ongoing Phase II/III development plan for evenamide. The first potentially pivotal study of this development program, study 008A, with evenamide as add-on therapy in patients with chronic schizophrenia experiencing inadequate response to their current antipsychotics (but not diagnosed as having TRS) is enrolling patients, and results are expected in 2023.


Newron continues its dialogue with industry partners around potential future collaboration opportunities for the development of evenamide.

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