Safety study pushes back phase 3 trial of Newron’s schizophrenia drug

Switzerland’s neurology specialist Newron must hold off starting a phase 3 study of its schizophrenia drug evenamide to complete a small study to show safety at a higher dose, causing a further delay to development.

Clinical development has already been delayed by safety issues that arose unexpectedly in 2019 but the FDA agreed a plan to address the signals before phase 3 studies could begin.

A team of analysts from Jefferies noted that data from two phase 2 studies assuaged safety fears over the drug, showing no increased risk of irregular heartbeats and other cardiac events and no evidence of neurological side-effects including seizures.

The analysts led by Lucy Codrington said that management had hoped that a final phase 2 safety study of the highest dose could be run in parallel with phase 3 to save time.

But it’s now become apparent that the final safety study of a 30mg dose will have to be complete before phase 3 can begin.

This will delay the start of phase 3, which was originally slated for the third quarter of this year, to the final quarter at the earliest.

The analysts also noted that while one of the phase 2 studies was not powered to show efficacy, management will likely be disappointed by only a numerical improvement in symptoms based on a standard score, rather than a statistically significant result.

The phase 2 studies tested the 7.5mg and 15mg doses and the lowest dose will not be developed further.

Jefferies added that it may delay any potential partnership, where Newron hoped to retain US rights for the clozapine-treatment resistant schizophrenia indication, with a partner focused on the broader add-on indication while providing additional funds.

Newron will likely need the partner, or additional funds, to gather enough data to complete phase 3 studies around the end of 2022.

Shares in the company collapsed last year after it axed development of sarizotan for the rare genetic brain disorder Rett Syndrome and have never really recovered.

The company has also developed Xadago (safinamide) to treat Parkinson’s disease, which is approved in Europe and the US.

Earlier this month it announced plans with partner Zambon to begin a pivotal trial for a new indication covering Parkinson’s disease patients with levodopa induced dyskinesia.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.