Newron faces delay to would-be schizophrenia blockbuster

Newron has been forced to delay the start of a pivotal trial of its schizophrenia candidate evenamide – tipped as a potential blockbuster – after an FDA query about safety data from animal studies.

The Italian biopharma says the US regulator is concerned about “findings from a recently completed study in rats as well as [central nervous system] events at higher doses in dogs, and the potential implication of these findings for patients.”

The company says it will carry out additional studies in rats and humans to investigate the issue and is confident the FDA’s concerns can be “addressed satisfactorily,” but will have to delay its phase 2/3 programme for evenamide until it has had a chance to discuss the results of the new studies with the agency. Some changes to the pivotal trial design will also be required, it adds.

Shares in the company were down around 11% in mid-morning trading. Newron discussed the development with analysts and investors on a conference call later today, and company executives said that while they are not yet able to comment on the expected total duration of the delay, the requested studies should only take a couple of months to complete.

The company had been due to start a pair of phase 2/3 trials in the second quarter of this year, aiming for completion in the second half of 2020.  Analysts at Edison have previously suggested that a launch could be possible in 2022 based on that timeframe, or later if a confirmatory phase 3 trial is required.

They reckon that the scope for evenamide is “potentially huge” given the massive unmet medical need among schizophrenia patients who don’t respond to the current medicine armamentarium, and have modelled $900m in sales as an add-on therapy alone.

Evenamide is a sodium channel blocker that is being developed as an add-on therapy for schizophrenia patients who can’t control their symptoms using current atypical antipsychotic drugs, and also as an add-on to clozapine for treatment-resistant schizophrenia (TRS).

It is thought to work by blocking the post-synaptic release of glutamate, a neurotransmitter, and could avoid some of the side effects seen with existing drugs that block dopamine.

Newron has high hopes for the programme, which emerged from its internal ion channel discovery platform and acts on a different target to currently-approved atypical antipsychotics which work mainly via the dopamine pathway.

The company already markets Xadago (safinamide) as an add-on treatment for Parkinson’s disease, securing approval in 2017 after a marathon drug development effort that was also plagued by delays.

The company booked €4m in royalties from the drug last year from marketing partners including Zambon, but Edison says the take-up of the product has been slow as it competes in a highly genericised US Parkinson’s market.