FDA hits the red light on pivotal trials at Newron, demanding new studies after raising safety concerns
Two years after Newron $NWRN came up with a mixed set of Phase IIa data for its antipsychotic evenamide, the FDA is halting their move into pivotal work while the biotech explores the implications of some new safety concerns regarding the drug.
Those concerns involve signals spotted in a newly completed rat study — which were not explained — as well as “CNS events at higher doses in dogs, and the potential implication of these findings for patients.” Regulators now want to see some new animal and human studies done to address the safety issue before they launch Phase II/III.
Back when I last covered the drug in early 2017, the CMO was quite confident that Newron was on to something. The mean change for the Positive and Negative Syndrome Scale (PANSS) score overall was -5.1 for the add-on compared to -3.7 for the placebo, which Newron chief medical officer Ravi Anand described as “very close” to statistical significance. If you just looked at the positive side of the scale, he added, the results were statistically significant.
That’s borderline, but the Italian biotech clearly felt it was worth pursuing.
Anand now is in contact with the FDA to work out the next round of safety work to clear up the issues, with the company “confident that they can be addressed satisfactorily.”
Its shares were knocked down 12% Tuesday morning.