Neurocrine's Depression Drug Fails Phase 2 Trial, Latest Setback in Takeda Partnership

Neurocrine Biosciences has announced that its experimental depression drug, NBI-1070770, failed to meet its primary endpoint in a phase 2 clinical trial. This setback marks another disappointment for the company's psychiatry pipeline, which includes several assets licensed from Takeda in a 2020 deal.

Trial Results and Implications

The phase 2 study, which began in March, evaluated three doses of NBI-1070770 against placebo in 73 adults with major depressive disorder (MDD) who had not adequately responded to at least one antidepressant. The primary endpoint was change in depression severity by Day 5, measured using the Montgomery-Åsberg Depression Rating Scale.

Despite being well-tolerated, NBI-1070770 failed to outperform placebo in reducing depression symptoms. Dr. Sanjay Keswani, Neurocrine's Chief Medical Officer, expressed disappointment but noted that certain aspects of the data warrant further exploration.

Ongoing Challenges in Neurocrine-Takeda Collaboration

This failure is not isolated within the context of Neurocrine's collaboration with Takeda. Since the 2020 deal, which saw Neurocrine pay $120 million upfront for seven assets, the company has faced several setbacks:

1. A GPR139 antagonist failed to reduce anhedonia in depressed patients during a separate midstage trial.
2. Luvadaxistat, a DAAO inhibitor, was unsuccessful in two phase 2 trials for schizophrenia.

These outcomes highlight the challenges in developing effective treatments for complex psychiatric disorders and underscore the risks associated with large-scale licensing deals in the pharmaceutical industry.

Bright Spots and Future Directions

Despite these setbacks, not all news from the Neurocrine-Takeda partnership has been negative. Osavampator (NBI-1065845), an AMPA potentiator, showed promise in a phase 2 depression study. This success led Takeda to reclaim the Japanese rights to the compound, while Neurocrine retains rights for the rest of the world.

As the company continues to analyze the results from the NBI-1070770 trial, the pharmaceutical industry will be watching closely to see how Neurocrine navigates these challenges and what steps it will take to advance its psychiatry pipeline.