Neurocrine Biosciences has reported that its Phase II trial assessing NBI-1070770 in the adult population with major depressive disorder (MDD) failed to meet its primary goal when compared to a placebo.
The primary aim was to measure change in depression severity from baseline to day five using the Montgomery-Åsberg Depression Rating Scale (MADRS).
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However, the company noted that the treatment was generally well-tolerated.
Neurocrine Biosciences chief medical officer Sanjay Keswani said: “While we are disappointed that NBI-1070770 did not meet the primary endpoint, there are aspects of the data that warrant further exploration. Our team will continue to analyse these results so we can determine appropriate next steps.
“We are grateful to the patients, investigators and site staff who participated in this trial.”
The randomised, multi-centre, double-blind trial enrolled 73 subjects diagnosed with this condition who had not responded satisfactorily to at least one antidepressant during their current episode.
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By GlobalDataIt was aimed at evaluating the safety, tolerability, and efficacy of three different doses of adjunctive NBI-1070770 versus placebo, using a 1:1:1:3 allocation.
Adults aged 18 to 65 years were randomised and given the therapy or a placebo over a four-week period.
Major depressive disorder (MDD) is characterised by persistent low mood, diminished energy, impaired concentration, and lack of interest, among other symptoms.
The selective, orally active negative allosteric modulator targeting the NR2B subunit-containing N-methyl-D-aspartate (NMDA NR2B) receptor is under development as a potential therapy for this condition.
Neurocrine obtained development and commercialisation rights for the therapy from Takeda Pharmaceutical Company.
In July 2025, Neurocrine presented one-year data from its Phase III CAHtalyst Adult study of Crenessity (crinecerfont) for classic congenital adrenal hyperplasia. The findings indicated that subjects were able to maintain more physiologic glucocorticoid dosing while keeping key hormone levels at or below baseline.
