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An experimental depression drug that joined the Neurocrine Biosciences pipeline as part of a broader package from Takeda Pharmaceutical failed to meet the main goal of a mid-stage clinical trial. The biotech isn’t abandoning the asset just yet, but even if it does, it also has another depression drug from the Takeda deal that works differently and is further along in its clinical development.
The trial failure was for an oral small molecule code-named NBI-1070770. Neurocrine said late Monday that this drug did not meet the main goal of showing a change according to a widely used rating scale for assessing the severity of depression symptoms. While the San Diego-based biotech did not release specific details, it did say that the drug was well tolerated by study participants.
NBI-1070770 was developed to go after NMDA receptors, which are located throughout the central nervous system. There are already depression drugs available that address this target: Johnson & Johnson’s Spravato and Axsome Therapeutics’ Auvelity both block it. Neurocrine’s drug is a negative allosteric modulator, meaning that rather than binding to a primary site it binds to a secondary site of its target. That target is the NR2B subunit of NMDA. One advantage of hitting the subunit with a drug is the potential for fewer side effects.
The Phase 2 test of NBI-1070770 enrolled 73 adults who were diagnosed with major depressive disorder and had an inadequate response to at least one antidepressant. Participants were randomly assigned to receive one of three doses of the study drug or a placebo. The main goal was to assess the change in depression severity from baseline to day 5. A secondary goal measured the change from baseline to day 49.
In a note sent to investors, Leerink Partners analyst Marc Goodman wrote that expectations about the Neurocrine drug’s trial readout were minimal given prior failures of drugs that target the NR2B subunit of NMDA. As an example, he pointed to the 2019 Phase 3 failure of rapastinel, a drug that Allergan (now a part of AbbVie following its 2020 acquisition) was developing as an adjunctive treatment for major depressive disorder.
In 2020, Neurocrine paid Takeda $120 million up front to license development and commercialization rights to NBI-1070770 along with three additional clinical-stage psychiatry drug candidates and three non-clinical assets. One of those clinical-stage assets, luvadaxistat, last year fell short of the main goal of a Phase 2 test as a treatment for cognitive impairment associated with schizophrenia. Neurocrine subsequently terminated the license for that drug. The Neurocrine pipeline still lists two late-stage assets from the Takeda deal: NBI-1117568 for schizophrenia and osavampator for major depressive disorder.
The original deal called for Neurocrine and Takeda to share equally in the profits or losses of osavampator. Last January, the companies changed the agreement to a royalty-bearing license that grants Neurocrine the exclusive right to develop and commercialize this drug for all indications worldwide, except for Japan. Osavampator, a positive allosteric modulator of a target called AMPA, is currently in Phase 3 testing. In Phase 2 results reported in September, this once-daily oral drug showed statistically significant and clinically meaningful improvement in depression severity measured at days 28 and 56.
As for NBI-1070770, Neurocrine described its Phase 2 test as a signal-finding study. Despite the trial’s failure, company executives say there may still be more to learn.
“While we are disappointed that NBI-1070770 did not meet the primary endpoint, there are aspects of the data that warrant further exploration,” Chief Medical Officer Sanjay Keswani said in a prepared statement. “Our team will continue to analyze these results so we can determine appropriate next steps.”
Photo: Jolygon, Getty Images
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