A spotlight schizophrenia drug in Neurocrine's $2B Takeda deal flunks its first major test. But it's not giving up yet
When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”
On Tuesday, we got some idea of how difficult.
San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).
CMO Eiry Roberts noted the INTERACT study, which enrolled 256 patients and tested three dosing levels of luvadaxistat in a placebo-controlled setting, was “well-designed and executed” — leaving little room to maneuver in that endpoint. The PANSS score is designed to assess severity of schizophrenia symptoms.
From RBC analyst Brian Abrahams:
Our sense is that the miss on the primary endpoint, the PANSS negative score, was likely due to a true lack of efficacy, rather than any conduct issues such as baseline imbalances, global site variability or high placebo effect, though the company has not yet completed full analysis of PK characterization (recall there is a modest food effect). The company is not reporting whether there were any notable trends or dose dependent signals, suggesting there likely were none.
There is, though, still a silver lining. The drug — also known as TAK-831 — met the second endpoints assessing cognitive performance, and the side effects appeared consistent with previous studies.
All of that backs further clinical work with the help of Takeda, Roberts added.
Neurocrine had put down $120 million upfront to get its hands on a package of three clinical-stage drugs, plus four more preclinical therapies. Takeda is then in line for $495 million in development milestones plus $1.4 billion in commercial goal cash as well as royalties. Or it can trade in some of those milestones in favor of a 50:50 profit share — should it choose to opt-in.
The deal marked one of the last steps of a major R&D reorg at Takeda, which was looking to shed some weight and earn some cash after paying $62 billion to merge with Shire.
And the turn to focus on secondary endpoints was an option baked into the luvadaxistat program, execs told Stifel analyst Paul Matteis.
“(A)t the outset of this program, Takeda had been debating on whether to develop in schizophrenia negative symptoms or cognition, so a signal on the latter does align with some of the original scientific hypotheses,” he wrote, adding that they also emphasized “cognitive impairment in schizophrenia is a big unmet need and worth pursuing. That said, there’s also a lot of opacity here and zero data to analyze, so while the secondary endpoint signal seems interesting and may cushion the hit to the stock, it will take a full presentation/publication to really understand the prospects of ‘831.”
Shares in Neurocrine $NBIX ended up falling 7.05% to $101.71.
We will have to wait for the data. The company says it’s evaluating the results to determine the next steps.
Kevin Gorman, Neurocrine CEO