Neurocrine’s NBI-1117568 shows new positive Phase 2 results in schizophrenia

Neurocrine (NBIX) announced the presentation of data from the Phase 2 study of NBI-1117568 in adults with schizophrenia, which showed a significant improvement in symptoms and overall severity and highlighted new data on the safety and tolerability of the treatment. NBI-1117568 was generally safe and well tolerated at all doses studied, with treatment discontinuation rates due to adverse events similar between NBI-1117568 and placebo. Adverse events with the highest incidence for NBI-1117568 compared with placebo were somnolence and dizziness. Primary endpoint was the change in total Positive and Negative Syndrome Scale, or PANSS, score from baseline to Week 6. The study showed statistically significant improvements in PANSS total score with 20 mg of NBI-1117568 once daily by Week 3 and at all subsequent visits through Week 6. A statistically significant improvement was also observed by Week 2 in the Clinical Global Impression of Severity scale, with continued improvement seen at all following visits through Week 6. For all other doses, mean decreases from baseline at Week 6 in PANSS total and CGI-S scale scores were greater with NBI-1117568 than with placebo, but not statistically significant. Based on these positive Phase 2 results, a Phase 3 registrational program was recently initiated to further evaluate the efficacy, safety and tolerability of NBI-1117568 as a potential treatment for schizophrenia.