Neurocrine公司抑郁症新药II期研究未达主要终点

Core Insights - Neurocrine Biosciences announced that its investigational depression drug NBI-1070770 failed to meet its primary endpoint in a Phase II clinical trial, adding challenges to its collaboration with Takeda Pharmaceuticals [1][2] Group 1: Drug Information - NBI-1070770 is a selective oral NMDA receptor negative allosteric modulator developed for adults with major depressive disorder (MDD) who have insufficient response to at least one antidepressant [2] - The drug's development rights originated from a 2020 collaboration between Neurocrine and Takeda, where Takeda granted exclusive rights to seven investigational drugs, with NBI-1070770 being a key asset for depression [2] Group 2: Clinical Trial Details - The Phase II clinical trial started in March of the previous year, designed as a randomized, multi-center, double-blind, placebo-controlled study, enrolling 73 eligible MDD patients [2] - Patients were allocated in a 1:1:1:3 ratio to three different dosage groups of NBI-1070770 and a placebo group, with a treatment duration of four weeks [2] - The primary endpoint was assessed on day five of treatment using the Montgomery-Åsberg Depression Rating Scale (MADRS) to evaluate changes in depression severity from baseline [2] Group 3: Trial Results and Future Directions - Neurocrine stated that NBI-1070770 was generally well-tolerated during the trial, with no serious adverse events reported, but none of the dosage groups showed statistically significant differences compared to the placebo on the primary endpoint [2] - The Chief Medical Officer expressed disappointment over the results but noted that there are still aspects of the data worth further investigation, and the team will continue to analyze to determine future directions [2] - Despite the Phase II study not meeting its primary endpoint, Neurocrine has other ongoing projects in the depression field, including another drug, osavampator, which showed positive Phase II data and has entered Phase III clinical trials as of January 2025 [2]