Neurocrine presents new data from Phase 3, open-label KINECT 4 study

Neurocrine (NBIX) Biosciences announced the presentation of a new post-hoc analysis from the Phase 3, open-label KINECT 4 study, demonstrating that patients treated continuously for 48 weeks with the 40 mg dose of once-daily INGREZZA capsules experienced clinically meaningful improvements in tardive dyskinesia symptoms. Findings will be presented at the American Psychiatric Nurses Association 39th Annual Conference, taking place October 15-18 in New Orleans. Efficacy outcomes demonstrated that clinically meaningful improvements in TD were sustained throughout the 48-week treatment period in both the INGREZZA 40 mg and INGREZZA 80/40 mg groups: At all post-baseline visits (Week 4 to Week 48), the mean change from baseline in AIMS total score exceeded the minimally clinical important difference threshold, demonstrating rapid and continuous improvements with INGREZZA treatment. Among those who received 40 mg throughout the entire study, the percentage of participants meeting the AIMS response threshold (greater than or equal to50% total score improvement from baseline) generally increased over time, with 90% (18/20) of those completing 48 weeks reaching this threshold. The analysis also showed that patients who reduced their dose from 80 mg to 40 mg for tolerability reasons achieved similar therapeutic benefits. From Week 8 through Week 48, more than half of all participants across both treatment groups met the response threshold for CGI-TD and PGIC, with 90% (18/20) of participants on continuous INGREZZA 40 mg treatment being “much improved” or “very much improved” at Week 48 per clinician assessment and patient self-report. Efficacy outcomes with INGREZZA 40 mg were comparable to those achieved with 80 mg in the original KINECT 4 study. In the study, safety and tolerability of treatment was consistent with the known profile of INGREZZA with no new concerns identified, and most treatment-emergent adverse events were mild or moderate in intensity. The most common side effects of INGREZZA in people with TD are sleepiness and tiredness.