Neurocrine’s Takeda-partnered depression programme finds mid-stage success
临床结果临床2期引进/卖出临床3期
Shares of Neurocrine Biosciences saw a modest 5% bump on Tuesday after revealing that its experimental treatment for major depressive disorder (MDD) met the primary and key secondary endpoints in the Phase II SAVITRI study.
It’s the second company to post positive MDD data in as many weeks. Intra-Cellular’s stock rose as much as 28% after its Caplyta (lumateperone) succeeded in a Phase III trial as adjunctive therapy to antidepressants. The atypical antipsychotic reduced Montgomery Åsberg Depression Rating Scale (MADRS) total score by 4.9 points more than placebo at week six.
Neurocrine’s NBI-1065845, a once-daily oral AMPA positive allosteric modulator, also led to statistically significant improvements in MADRS total score versus placebo in patients with MDD who have not benefited from treatment with at least one antidepressant.
The company did not disclose the specific dose that achieved the primary endpoint, but said that at day 28, the investigational drug demonstrated a 4.3-point lower score than placebo. By day 56, the gap had widened to 7.5 points in favour of NBI-1065845.
With an adverse event profile similar to placebo – and headaches as the most common side effect – the candidate also appeared to meet a safety bar set by Morgan Stanley analysts, who previously predicted that the Phase II results could set up NBI-1065845 as a competitor to Johnson & Johnson’s ketamine derivative Spravato (esketamine), “but with improved tolerability.”
In a Phase III trial reported last year, nearly half the patients with treatment-resistant MDD who had received the pharma’s eskatamine nasal spray reported dizziness, and about a third experienced nausea and dissociation.
NeurocrineNeurocrine gained an exclusive licence to NBI-1065845, along with six other antipsychotics, as part of a broad 2020 deal with Takeda. The AMPA-targeting treatment’s clinical success comes roughly six months after a separate ex-TakedaTakeda programme failed in a Phase II trial to treat MDD patients with anhedonia.
Under the deal terms, Neurocrine and Takeda have an agreement to equally split profits for NBI-1065845 as well as NBI-1065846 (TAK-041/zelatriazin), a small-molecule agonist of GPR139, though the Japanese pharma can opt out and instead receive development and commercial milestone payments.
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