A brand new section 2 examine from Neurocrine Biosciences confirmed statistically important and clinically significant enchancment in melancholy severity with each day administration of 1 mg osavampator (NBI-1065845).1 The examine met its main and secondary endpoints in exhibiting better than 50% discount in melancholy severity from baseline to day 28 and from baseline to day 56, as measured by the Montgomery-Asberg Melancholy Ranking Scale (MADRS).
This section 2, double-blind SAVITRI examine included 183 adults 18 to 65 years outdated, randomized into placebo, osavampator 1 mg, and osavampator 3 mg teams. Contributors acquired their assigned remedy as soon as each day for 8 weeks. All individuals had a main analysis of main depressive dysfunction (MDD) and had an insufficient response (lower than 50% enchancment) to their present antidepressant remedy. The examine met its main endpoint, exhibiting a statistically important discount in melancholy severity (as measured by MADRS whole rating) from baseline to day 28, in contrast with placebo (P=0.0159). A secondary efficacy endpoint was additionally met, with statistically important discount in MADRS rating from baseline to day 56 (P=0.0016). At day 56, osavampator 1 mg maintained significance in discount, whereas osavampator 3 mg confirmed favorable however finally nominal distinction in discount. Remission charges (MADRS whole rating of 10 or much less) have been statistically important within the 1 mg osavampator group, whereas the three mg osavampator group confirmed numerical enchancment however not statistical significance.
At each 1 mg and three mg doses, osavamaptor was usually well-tolerated, with no severe hostile occasions. Essentially the most generally reported treatment-emergent hostile occasions which occurred in 5% or extra of sufferers have been headache and nasopharyngitis; charges of those hostile results in remedy teams have been just like placebo. Different reported hostile results in teams receiving osavampator embody insomnia (n=1 (1 mg group), n=3 (3 mg group)), somnolence (n=3 (1 mg group)), and nausea (n=1 (1 mg group)).
Osavampator is an investigational selective optimistic allosteric modulator for alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPA-PAM).2 The remedy is being developed as a possible adjunct for adults with MDD who’ve a valuable insufficient response to oral antidepressant remedy.
“Main depressive dysfunction is without doubt one of the commonest psychological well being situations, and as much as half of sufferers don’t get ample aid from their present antidepressant routine,” stated Sanjay Keswani, MD, chief medical officer of Neurocrine Biosciences. “We’re inspired by these outcomes that present osavampator could assist handle this unmet want by modulating AMPA receptor exercise.”
Primarily based on these outcomes and an exploratory put up hoc exposure-response evaluation, Neurocrine Biosciences will proceed to guage the 1 mg osavampator each day dosing in section 3 research. The corporate has initiated registration for a section 3 program, with 5 actively enrolling research.
References
1. Neurocrine Biosciences presents optimistic new information from section 2 examine of osavampator in adults with main depressive dysfunction. Press launch. September 22, 2025. Accessed September 23, 2025. https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-positive-new-data-from-phase-2-study-of-osavampator-in-adults-with-major-depressive-disorder-302562476.html
2. Freudenberg F, Reif-Leonhard C, Dawson GR, et al. All roads result in glutamate: NMDA and AMPA receptors as targets for rapid-acting antidepressants. Pharmacol Res. 2025;220:107918.