The add-on medication for schizophrenia developed by Newron Pharmaceuticals was shown to reduce both positive and negative symptoms, as well as the severity of the condition, in patients who were participating in phase 2/3 research.
Evenamide, which might be coupled with a line of care such as clozapine for those with chronic conditions who do not react to current medications, is now being developed by an Italian biotech company in an effort to bring forth the first therapy for schizophrenia in decades.
As stated in a press release, the primary objective of the study was to demonstrate improvement on a scale that measures positive and negative symptoms associated with schizophrenia. This scale is known as the Positive and Negative Syndrome Scale (PANSS). Delusions, hallucinations, exhilaration, and grandiosity are examples of positive symptoms, whereas emotional and social retreat, trouble with abstract thinking, and muted affect are examples of negative symptoms. In addition, patients who received evenamide had a reduction in the extent of their disease, which was an important secondary goal.
A total of 291 patients were given either the study medicine or a placebo along with their prescribed antipsychotic medication throughout the course of the four-week trial known as Study 008A, which was carried out at 45 centres located in 11 different countries.
In the course of the experiment, three patients ended their participation owing to adverse effects, including two patients who were taking evenamide and one who was taking a placebo and passed away. Overall, throughout the course of the study, no safety issues were found, and there was no difference in the rate of adverse events involving the central nervous system, the gastrointestinal tract, or any other adverse events between the two groups.
Newron referred to the primary endpoint findings as “highly statistically significant,” revealing that patients administered evenamide experienced a noteworthy reduction of 10.2 points on the PANSS scale by Day 29, compared to 7.6 points for those in the placebo cohort.
In a previous update, Newron disclosed that the efficacy of evenamide exhibited a progressive trajectory between six months and one year. Notably, the biotech observed a remarkable over 50% escalation in the six-week change on the PANSS symptom scale after one year, with a 30% change noted after six months.
Newron intends to unveil further insights from the study in the forthcoming weeks. Additionally, the company aims to leverage the data to advocate for a “potentially pivotal” phase 3 trial, evaluating evenamide’s efficacy over a span of one year in individuals grappling with treatment-resistant schizophrenia.
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