Shares in Neurocrine (NASDAQ:NBIX) Biosciences fell sharply in premarket trading Wednesday after the company reported Phase 2 study results for NBI-'568, its investigational oral drug for treating schizophrenia.
Per the announcement, the study met its primary endpoint for the once-daily 20mg dose.
Neurocrine stated NBI-'568 “demonstrated a clinically meaningful and statistically significant reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6 with a placebo-adjusted mean reduction of 7.5 points and an 18.2-point reduction from baseline.”
Still, the company’s shares fell nearly 15% in the premarket trade.
The once-daily 20 mg dose of NBI-1117568 also showed notable improvements for other standpoints, including those in the Clinical Global Impression of Severity (CGI-S) scale, Marder Factor Score – Positive Symptom Change, and Marder Factor Score – Negative Symptom Change, the company said.
"This Phase 2 dose-finding study delivered on our goal of identifying a once-daily, well tolerated dosing regimen with a compelling and competitive benefit-risk profile," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
The biotech firm said the drug was found to be generally safe and well-tolerated in Phase 2 trials, with similar discontinuation rates due to adverse events between the drug and placebo groups.
The most common side effects were somnolence, dizziness, and headache, while gastrointestinal issues like nausea and constipation were infrequent and comparable to placebo.
Cardiovascular events were also rare and not considered clinically significant at any dose tested.