Newron delays pivotal schizophrenia trials amid safety fears

Newron Pharmaceuticals has delayed the start of phase 2/3 schizophrenia studies at the request of the FDA. The agency requested the delay after seeing data from studies of evenamide in mice and dogs.

Evenamide, an oral selective glutamate inhibitor, came through an 89-patient phase 2a trial in 2017 without setting off any safety alarms. And, with the trial linking evenamide to improvements on a scale of schizophrenia symptom severity, Newron planned to start a pair of phase 2/3 trials designed to support regulatory authorizations. The trials were due to start in the second quarter of 2019.

That plan is now on hold. Newron attributed the delay to a communication from the FDA indicating concerns with the findings of a recently completed study in rats and the central nervous system events seen in dogs that received higher doses of evenamide.

Worried about the implications for the use of evenamide in humans, the FDA asked Newron to run short-term exploratory studies in rats and human subjects before embarking on the pivotal program. The request will further delay the start of the phase 2/3 trials, which at one point were due to begin before the end of 2018.

News of the delay wiped 11% off Newron’s share price in early trading in Switzerland. Newron thinks it can bounce back from the blow, though.

“Based on the issues raised by the FDA letter, Newron is confident that they can be addressed satisfactorily,” Chief Medical Officer Ravi Anand said in a statement. 

The delay means sarizotan will remain the only experimental asset in Newron’s late-phase pipeline for some time. Sarizotan, a 5-HT1a and D2-like receptor agonist licensed from Merck KGaA, moved into a phase 3 trial in patients with Rett syndrome in 2016 and is due to deliver results in the fourth quarter. At one point, Newron expected to report results in the first half of 2019.

Newron secured €40 million ($45 million) from the European Investment Bank late last year to fund late-phase development of sarizotan and evenamide.