Newron announce successful results from schizophrenia study
pharmafile | April 1, 2021 | News story | | schizophrenia
Newron, a biopharmaceutical company focused on novel therapies, have announced the initial results from two short-term exploratory studies assessing the safety and effects of evenamide, with the aim of using the drug in the future treatment of patients with schizophrenia.
The studies examined the drug’s effects on healthy volunteers (study 010) and also on patients with schizophrenia (study 008), following an FDA request.
Study 010 took place over four weeks using 56 participants and compared evenamide at 30mg and 60mg doses with moxifloxacin at 400mg and a placebo. The study looked at the QT segment specifically alongside the electrocardiogram (ECG), following an FDA request under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The study’s results indicated that evenamide was devoid of any QTcF prolongation compared to placebo (indicating lack of any increased risk of arrythmia), while moxifloxacin was associated with a 17.3 ms median maximum increase, suggestive of clinically significant risk of arrhythmia. These results thereby suggest that evenamide does not increase a patient’s risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.
Study 008 was requested by the FDA to evaluate the safety, tolerability, and electroencephalogram (EEG) effects of two fixed doses of evenamide, 7.5mg and 15mg. This was requested to address questions which arose from a study of evenamide in rats, and central nervous system (CNS) events observed following high-dose administration of evenamide in dogs.
The study span across four weeks and involved 138 outpatients with chronic schizophrenia, receiving treatment with a second-generation atypical antipsychotic at study centres in the US and India. No patients on the study experienced adverse events relating to evenamide with no symptoms observed suggestive of severe CNS events, seizures, EEG diagnosis of seizure like activity, or cardiac events.
A further study, 008A, will now commence in patients with schizophrenia using increased doses (30mg) as the designated therapeutic dose. Study 008A will be initiated in the next few days, with results expected in the second half of 2021.
Ravi Anand, MD, Newron’s CMO, said: “The results of study 010 are of far-reaching importance as they indicate that evenamide, even at doses of 60mg (twice the therapeutic dose), is devoid of any arrhythmic effect and thus can be safely added to any other antipsychotic.
“Furthermore, the safety data, specifically, the lack of any systemic pattern of adverse effects relating to the CNS (including EEG) indicate that the drug is safe at the doses investigated. We will now evaluate the safety of the 30mg (BID) dose, the expected therapeutic dose, in patients with schizophrenia, in study 008A and plan for the initiating of our phase III program shortly after.”
The proposed Phase III clinical trial will target patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and treatment-resistant patients not responding to clozapine. Clozapine is the only antipsychotic approved worldwide for treatment resistant schizophrenia. The program will commence once study 008A results are available.
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