Neurocrine Biosciences reported Phase 2 schizophrenia data Wednesday morning as it chases Bristol Myers Squibb and AbbVie in an emerging field.
The new data showed the low dose of Neurocrine’s program, called 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. That 7.5-point difference reached statistical significance with a p-value of p=0.011.
Investors appeared disappointed with the topline results, as Neurocrine’s stock $NBIX fell more than 15% premarket Wednesday morning. An analyst note from Leerink’s Marc Goodman said the company previously guided toward an eight-point difference as a bar for efficacy.
In addition, none of the other three dosing groups reached statistical significance, and the topline PANSS changes were numerically smaller than data Karuna reported last year from two Phase 3 studies (8.4 and 9.6) as well as its Phase 2 trial in 2021 (11.6) of its candidate, KarXT.
Neurocrine’s drug is a muscarinic 4 agonist, a similar mechanism of action to KarXT, which is an M1/M4-preferring muscarinic agonist. Bristol Myers completed its $14 billion acquisition of Karuna in March, and the FDA is expected to make a decision by Sept. 26.
Cerevel, whose acquisition by AbbVie closed this month, is also running Phase 2 trials for a similar drug, dubbed emraclidine. MapLight Therapeutics snagged a $225 million Series C late last year to run a Phase 2 trial as well, which as of March, was planned to start in “late” 2024.