Newron plots phase 3 trial of schizophrenia drug after safety scare
Newron Pharmaceuticals has clearance to press ahead with phase 3 development of its schizophrenia drug Evenamide after the FDA agreed a plan to address potential safety issues emerging from preclinical data.
Safety issues with Evenamide arose unexpectedly last year – although there were positive clinical safety data from a phase I/IIa proof-of-concept study more than two years ago, the FDA picked up on toxicity issues in rats and CNS events observed in dogs at higher doses.
The FDA requested a meeting with Newron amid concerns about a class issue with Evenamide, which the company is developing as the potential first add-on therapy for patients with positive symptoms of schizophrenia.
After a meeting last August the FDA has approved a plan proposed by Newron for a phase 3 trial, but only after a short four-week study in patients with schizophrenia that is expected to start enrolling patients in the next few days.
Newron expects initial results from additional studies in rats and humans in Q3 this year – and if results check out Newron expects to begin phase 3 development.
The trials will test the drug in patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and for treatment-resistant patients not responding to the antipsychotic drug clozapine.
If approved Evenamide would be the first therapy available in this indication and works by targeting voltage-gated sodium channels.
The result of ion channel research by the Italian pharma company, Evenamide modulates sustained repetitive firing of neurons without inducing impairment of their excitability, normalising glutamate release caused by aberrant sodium channel activity.
A phase 2a study showed Evenamide significantly improved symptoms of psychosis compared with placebo when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia.
The study also indicated that Evenamide is devoid of an effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics.