As Regulators Gear Up To Decide On Bristol Myers' Schizophrenia Treatment, Neurocrine Biosciences' Data Disappoints Investors

Wednesday, Neurocrine Biosciences, Inc. NBIX topline data for its Phase 2 clinical study of NBI-1117568 (NBI-‘568) in adults with schizophrenia.

NBI-‘568 is the first investigational, oral, muscarinic M4 selective agonist.

The new data showed that the once-daily 20 mg dose of NBI-‘568 induced an average 18.2-point reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) after six weeks, compared to 10.8 points in the placebo group.

Also Read: Regulators Expected To Approve Innovative Schizophrenia Treatment From Bristol Myers, Karuna.

That 7.5-point difference reached statistical significance with a p-value of p=0.011.

The company noted that none of the other three higher-dosing groups (30, 40, and 60 mg) reached statistical significance.

William Blair notes that while this effect size is in line with what was demonstrated by Bristol Myers Squibb Co BMY acquired Karuna’s KarXT, the 7.5 delta versus placebo is lower than the 11.6 difference in the Phase 3 EMERGENT-2 study.

It was also lower than the 0.75 effect size and 11.6-point delta from placebo from the EMERGENT-1 Phase 2 study and the 12.7-point and 11.1-point improvement over placebo with AbbVie Inc’s (formerly Cerevel’s) ABBV emraclidine.

“We do highlight that the placebo improvement of 10.8 points is greater than what was seen in prior Phase II studies of KarXT and emraclidine, which is unsurprising given potential expectation bias around a more well-validated mechanism and is more in line with prior studies of antipsychotics historically,” William Blair analyst adds.

Price Action: NBIX stock is down 18.90% at $123.71 at the last check on Wednesday.

Read Next:

• Novartis’ Cholesterol-Lowering Drug Shows Encouraging Outcome In Late-Stage Study.