#United States #San Diego #MDD #Neurocrine Biosciences #NBI-1070770

Introduction

Neurocrine Biosciences, Inc. has recently provided an update regarding its Phase 2 clinical trial for NBI-1070770, an investigational treatment aimed at addressing major depressive disorder (MDD) in adults. The company disclosed that the study did not achieve its primary endpoint when compared to a placebo.

Study Overview

This Phase 2 trial involved 73 adult participants diagnosed with major depressive disorder, specifically those who had not responded adequately to at least one previous antidepressant during their current treatment episode. The primary objective of the study was to measure changes in the severity of depression, utilizing the Montgomery-Åsberg Depression Rating Scale (MADRS) to assess results from baseline until Day 5 of the trial.

Dr. Sanjay Keswani, the Chief Medical Officer at Neurocrine Biosciences, expressed disappointment over the primary endpoint not being met. However, he highlighted that certain data aspects could suggest new avenues for further exploration, indicating an ongoing commitment to understanding the compound's efficacy. Neurocrine plans to continue analyzing the trial results for insights that may guide future development stages.

About NBI-1070770

NBI-1070770 acts as a selective and orally active negative allosteric modulator (NAM) for the NR2B subunit of the N-methyl-D-aspartate (NMDA) receptor. It was originally developed by Takeda Pharmaceutical Company, from whom Neurocrine obtained rights for further development and commercialization.

Clinical Study Details

This multicenter, randomized, double-blind, placebo-controlled trial adopted a structured approach with the inclusion of various dosage strengths facilitated in comparison to a placebo. Each participant received their respective treatment over a duration of four weeks. Notably, the study incorporated specific criteria to select participants: individuals aged between 18 and 65 years who had demonstrated an inadequate response to prior antidepressant therapies were eligible for participation.

Mental Health Context

Major depressive disorder is a profound mental health condition distinguished by persistent melancholy, diminished interest in daily activities, impaired concentration, and reduced energy levels, among other related symptoms. Recognized by the World Health Organization as a leading source of disability worldwide, MDD poses significant risks including heightened chances of self-harm and suicide. In the United States, over 21 million individuals are affected by this disorder, with nearly half unable to achieve sufficient relief from their initial medications.

Neurocrine’s Commitment

Neurocrine Biosciences has built its reputation within the field of neuroscience-focused biopharmaceuticals with a clear objective: to mitigate suffering for those with serious neurological, neuroendocrine, and neuropsychiatric disorders. The company prides itself on its robust pipeline which includes several FDA-approved treatments and compounds currently under mid-to-late phase clinical development.

Future Prospects

While the Phase 2 study for NBI-1070770 did not meet its primary endpoint, Neurocrine remains hopeful and focused on assessing the results comprehensively. The potential for future clinical trials to explore the benefits of NBI-1070770 persists, thus offering a glimmer of hope in the ongoing challenge of treating major depressive disorder effectively.

In conclusion, updates from Neurocrine's study reveal not just challenges, but opportunities for growth and deeper investigation in the fight against major depressive disorder.