In a Phase 2 study, Neurocrine Biosciences’ NBI-1065845 has shown promise in treating major depressive disorder (MDD). The study, called SAVITRI, met its primary and key secondary endpoints, demonstrating that once-daily oral administration of NBI-1065845 produced a statistically significant improvement in Montgomery Åsberg Depression Rating Scale (MADRS) total score at both Day 28 (primary) and Day 56 (secondary).
One of the doses of NBI-1065845 demonstrated improvement over placebo of -4.3 (p-value = 0.0159) and -7.5 (p-value = 0.0016) at Day 28 and Day 56, respectively. The other undisclosed dose did not achieve statistical significance but demonstrated a trend toward improvement over placebo of -3.0 (p-value = 0.0873) and -3.6 (p-value = 0.1082) at Day 28 and Day 56, respectively.
NBI-1065845 was generally well-tolerated, with headache being the most common adverse event. The adverse event profile for both doses of NBI-1065845 was comparable to placebo. There were no deaths or serious adverse events. The discontinuation rates were low throughout the study.
Neurocrine Biosciences is collaborating with Takeda Pharmaceutical Company Limited on the development and commercialization of NBI-1065845. The company’s recent update has been met with cautious optimism, as it indicates the potential for a significant sales opportunity for a new antidepressant mechanism. However, replication in pivotal studies is crucial to confirm the efficacy and safety of NBI-1065845. Investors are also eagerly awaiting updates on the company’s M4-agonist ‘568 program, given positive results from similar programs in the industry.
