First Patient Randomized in Phase 2 Trial to Assess Efficacy of NBI-1070770 for MDD

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Neurocrine Biosciences announced on April 3, 2024 the first patient has been randomized to receive NBI-1070770 for major depressive disorder (MDD) in a phase 2 clinical trial.¹

MDD, characterized by a depressed mood, loss of interest or enjoyment in daily activities, and reduced energy, is one of the leading causes of disability.² Despite the available antidepressants on the market, about a third of 16 million in the US with MDD do not respond to current treatments.

NBI-1070770, an investigational, oral, negative allosteric modulator of the NR2B subunit-containing N-methyl-D-aspartate receptor, is being developed for the potential treatment of patients with inadequate response to current antidepressants.

In a multicenter, randomized, double-blind, placebo-controlled study, investigators will assess the investigational compound’s efficacy, safety, and tolerability in approximately 72 adults with MDD throughout various centers in the United States.¹ Investigators will compare the safety and efficacy of NB-1070770 in participants with MDD compared to placebo, aiming to see how NBI-1070770 improves MDD symptoms. Participants will be randomized into 1 of the 4 groups: NBI-1070770 at low dose, NBI-1070770 at median dose, NBI-1070770 at high dose, and placebo.³

The primary endpoint is the change in the total Montgomery-Åsberg Depression Rating Scale score from baseline to day 5. The secondary endpoint is the change in the total Montgomery-Åsberg Depression Rating Scale score from baseline to day 49.

Eligibility criteria include being 18 – 65 years old, having a diagnosis of recurrent MDD or persistent MDD, and if on antidepressants, they must have been taking their current antidepressant medications for ≥ 8 weeks before screening and must be willing to continue to take the current antidepressants during the study.

The study is estimated to be completed in December 2025, with a primary completion in September 2025.

“Based upon our Phase 1 first-in-human study, we are excited to bring this novel oral compound, which acts through a clinically validated mechanism of action, into clinical development as a potential treatment for major depressive disorder,” said Eiry W. Roberts, MD, chief medical officer at Neurocrine Biosciences, in a press release.¹ “The selectivity of NBI-1070770 for the NMDA NR2B receptor has the potential to benefit patients who have moderate to severe depression.”

^References

1. ^{Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder. PR Newswire. April 3, 2024. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-first-patient-dosed-in-phase-2-clinical-study-evaluating-nbi-1070770-in-adults-with-major-depressive-disorder-302106187.html. Accessed April 3, 2024.}
2. ^{Our Pipeline. NEUROCRINE BIOSCIENCES. https://www.neurocrine.com/pipeline/. Accessed April 3, 2024.}
3. ^{A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults with Major Depressive Disorder. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT06267846?cond=Major%20Depressive%20Disorder&term=NBI-1070770&rank=1. Accessed April 3, 2024.}