- Neurocrine Biosciences, a San Diego-based drug developer, said Tuesday an experimental schizophrenia medicine that it recently licensed from Takeda has failed a key test.
- The medicine, known as luvadaxistat, is supposed to help schizophrenia patients with "negative symptoms" — a term that encompasses a range of hard-to-treat conditions like lack of motivation, trouble communicating and limited emotion. But, according to results from a mid-stage study, patients treated with the drug didn't perform significantly better than those given a placebo, as measured by a scale that assesses the severity of negative symptoms.
- Though luvadaxistat didn't hit its main goal, it did succeed on secondary endpoints focused on cognition. Neurocrine leadership has found those results encouraging enough to warrant further clinical evaluation of the drug. In a statement, Eiry Roberts, Neurocrine's chief medical officer, said the company plans to work with Takeda to move luvadaxistat forward.
Neurocrine made a big bet on Takeda's psychiatry drugs last summer, licensing seven programs in a deal valued at over $2 billion.
Luvadaxistat was the most advanced of the group, having entered Phase 2 testing in 2017. The drug is meant to block an enzyme that degrades a certain kind of amino acid important for brain function.
While the science behind luvadaxistat has drummed up excitement, Wall Street analysts lost much of their optimism in the program last month, after Massachusetts-based Concert Pharmaceuticals reported disappointing results for a experimental drug meant to work similarly.
Despite lowered expectations, the negative results for luvadaxistat still knocked Neurocrine's share price down more than 7%. Shares traded at $101 apiece Tuesday morning, a little more than 20% lower than last June, when Neurocrine inked its deal with Takeda.
Neurocrine hasn't given up, however. The biotech now appears to be reshaping its development plans based the drug's potential impact on cognition.
Paul Matteis, an analyst at Stifel, wrote to clients that his team was able to connect with Neurocrine and get more context about the luvadaxistat program and its path forward. According to Matteis, Takeda initially debated whether to develop the drug in schizophrenia negative symptoms or cognition, implying that the signal seen in the mid-stage study does align with the company's original scientific hypotheses.
Moreover, there remains a large need for treatments that can combat cognitive impairment in schizophrenia patients. If luvadaxistat were to gain approval in that indication, it could provide a valuable source of revenue diversification for Neurocrine, which is almost entirely reliant on Ingrezza, its marketed therapy for tardive dyskinesia.
"That said, there's also a lot of opacity here and zero data to analyze," Matteis wrote, echoing other analysts who wrote the prospects for luvadaxistat won't be fully understood until data are published or presented.