Neurocrine was forced to concede that its lead drug – already on track at the FDA with an application for tardive dyskinesia — just flunked a Phase II trial in Tourette syndrome.
The VMAT2 inhibitor improved symptoms among the patients taking the drug, but failed to hit the primary endpoint for the change-from-baseline in the Yale Global Tic Severity Scale at week 8. The biotech, though, is keeping the hard data under wraps for now.
Don’t look for the company $NBIX to throw in the towel. Their statement implied that they’re going to take what they learned from this setback and apply it again in another study.
Their stock slid a bit more than 5% in after-hours trading, an initial indication that investors didn’t see the setback as catastrophic.
“At present, we are not disclosing specific details of this study in order to avoid the potential introduction of assessment bias in the ongoing Phase II T-Force GREEN study of pediatric Tourette patients,” noted CEO Kevin Gorman. “We look forward to the pediatric study readout next quarter and our subsequent discussion with the FDA on our plans for Phase III development of Ingrezza in Tourette syndrome.”
A total of 124 patients were enrolled in 32 centers.
Just a few days ago the FDA announced that they were scrapping plans for a panel review of the drug for tardive dyskinesia, a move that several analysts took as a positive indication of its reception at the agency. The PDUFA date for that indication is set for April 11.
Chris O’Brien, the chief medical officer of Neurocrine, said:
Through this initial placebo-controlled study we gained valuable insights into the conduct of clinical trials in Tourette patients, including patient identification methods and appropriate study inclusion/exclusion criteria. As we have done with our previous early Phase II studies in both endometriosis and tardive dyskinesia, we will apply these new insights to future Tourette studies.
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