Newron Pharmaceuticals announced the planned Phase II/III clinical trials of evenamide for schizophrenia will be delayed due to safety concerns. The company received communication from the U.S. FDA indicating concern on findings from a recently completed study in rats as well as CNS events at higher doses in dogs, and the potential implication of these findings for patients. This led the FDA to request Newron to delay initiation of the proposed Phase II/III pivotal studies prior to completing additional short-term explanatory studies in rats and human subjects to address these concerns.
The start of the proposed phase II/III studies will delayed until after the discussion of the results of the animal studies with the FDA and making necessary changes in the planned pivotal studies. Newron plans to meet with the FDA soon and will provide additional details and an update on evenamide following the meeting.
In March of 2017, Newron presented the results of a Phase IIa study with Evenamide at the 16th International Congress on Schizophrenia Research in San Diego as well as the 30th European College of Neuropsychopharmacology Congress. The study demonstrated evidence of efficacy in significantly improving symptoms of psychosis compared with placebo when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia. It also indicated that Evenamide is devoid of an effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics. At that time evenamide was reported to be well tolerated.
Schizophrenia is a long-term mental health condition that causes a range of different psychological symptoms. It is one of the most common serious mental health conditions. About 1 in 100 people will experience schizophrenia in their lifetime, with many continuing to lead normal lives. Schizophrenia is often described in terms of positive and negative (or deficit) symptoms. Positive symptoms are those that most individuals do not normally experience but are present in people with schizophrenia. They can include delusions, disordered thoughts and speech, and tactile, auditory, visual, olfactory and gustatory hallucinations, typically regarded as manifestations of psychosis. Positive symptoms generally respond well to medication. Negative symptoms are deficits of normal emotional responses or of other thought processes and are less responsive to medication.
Evenamide has a unique mechanism of action: glutamate modulation and voltage-gated sodium channel blockade. Evenamide modulates sustained repetitive firing, without inducing impairment of normal neuronal excitability. It normalizes glutamate release induced by aberrant sodium channel activity. As it is devoid of the risk of drug-induced movement disorders or weight gain, Evenamide can be given in combination for extended periods of time.