Evenamide update/orphan drug application, TRS

I don’t know how to attach a pdf, but Newron recently (Sept) updated their page with a pdf report to shareholders that they are going for orphan drug designation with Evenamide in treatment resistant schizophrenia. They expect an answer from the FDA in the first quarter of 2018.

They are also planning 2 studies in the EU of 6 and 8 weeks, one in clozapine resistant patients and one in patients experiencing worsening symptoms on antipsychotics they previously responded to.

They expect a response for their trial designs from regulators in Nov. The trials are expected to run for 18 months.

They are estimating that the phase 2b/3 trials will begin in 2019.

It’s the corporate presentation 2017.


They also noted that their drug was most effective in people under the age of 32 with less than 10 years of illness, so that is probably the group they will be looking for in their trial, along with the other criteria of clozapine resistant TRS or worsening on other APs.