Neurocrine’s Phase 2 Depression Drug Fails Primary Endpoint in Major Takeda-Licensed Study

Neurocrine Biosciences reported that its experimental depression drug NBI-1070770, licensed from Takeda, failed to achieve the primary endpoint in a Phase 2 trial for major depressive disorder (MDD)1 4 7 9.

The randomized study included 73 adults with MDD who had not responded sufficiently to at least one antidepressant; NBI-1070770 did not outperform placebo in reducing depression severity by Day 5 using the Montgomery-Åsberg Depression Rating Scale1 4 5 9.

While the drug was well-tolerated, the company’s Chief Medical Officer noted some data aspects may merit further exploration, but no next steps have been decided1 4.

This is the latest setback in Neurocrine’s collaboration with Takeda, following other recent midstage failures for different psychiatry assets from the same 2020 licensing deal1 2 6.

The partnership has not been uniformly unsuccessful:
Neurocrine’s osavampator (NBI-1065845), another Takeda-licensed compound, showed positive Phase 2 results in MDD earlier in 2024, leading Takeda to regain Japanese rights while Neurocrine retains global rights outside Japan1 6.

Neurocrine paid $120 million upfront in 2020 for rights to seven Takeda assets, with the overall collaboration marked by both promising and disappointing clinical results1 6.

Industry analysts observed that expectations for NBI-1070770 were low given the drug's mechanism and limited prior supportive data4.