Neurocrine scores surprise win with depression drug
License out/inPhase 2Clinical Result
Neurocrine Biosciences, a drugmaker focused on the brain and nervous system, said Tuesday that one of its experimental medicines succeeded in a clinical trial evaluating it as a treatment for major depression.
The medicine hit the Phase 2 trial’s main goal as well as “key secondary endpoints,” according to Neurocrine, which plans to meet with the Food and Drug Administration to discuss a path to late-stage testing. If positive results continue to pile up, the medicine could become the first of its kind to secure an approval.
Eiry Roberts, Neurocrine’s chief medical officer, called the newly released data “very encouraging” and reflective of the medicine’s potential to alleviate many of the symptoms associated with major depressive disorder. In the study, which pitted a low and a high dose of the oral drug against a placebo, those given one of the doses experienced significant changes on a well-known scoring system clinicians use to assess depression symptoms.
Four weeks into the study’s testing period, the scores of patients on that dose had declined 4.3 points more than what researchers observed in the placebo arm. And at eight weeks, the difference had grown to 7.5 points. Notably, NeurocrineNeurocrine didn’t specify which dose this was. The other dose “demonstrated a trend toward improvement” but was not significantly better than a placebo.
According to NeurocrineNeurocrine, patients generally tolerated its medicine well. The side effect profile of both doses was “comparable to placebo,” with headaches being the most common adverse event seen in the trial. No deaths or serious adverse events occurred, and few participants dropped out of the study.
Neurocrine said additional data will be shared at a future scientific meeting.
Shares of the company ticked up about 5% Tuesday morning, to trade just under $141 apiece.
In a note to clients, Paul Matteis, an analyst at the investment firm Stifel, wrote how investors had “very low” expectations for NeurocrineNeurocrine’s medicine. Placebo-controlled depression studies are notoriously difficult to succeed in, as patients in the control arms often do better than drugmakers anticipate. Many promising depression treatments have failed important experiments over the years.
NeurocrineNeurocrine’s tablet works differently than currently available depression therapies. It’s designed to amplify a protein involved in the transmission of glutamate, a chemical that’s abundant throughout the brain and nervous system. Glutamate is vital to cognition, memory and mood, and is found at lower levels in people with depression.
Analysts believe there are questions Neurocrine still needs to answer. Specifically, they want to know what dose of the medicine was more effective, how confident the company is in the safety findings, and whether researchers observed a large placebo effect.
Yet, Matteis and others now see Neurocrine’s medicine as a “novel” approach to treating major depression that “could have blockbuster potential.”
“While depression remains a difficult development indication due to high risk of placebo effects, we view Tuesday’s update as encouraging and potentially representative of a $1 billion-plus peak sales opportunity for a novel antidepressant mechanism,” Myles Minter, an analyst at William Blair, wrote in a note.
Minter added that the new results are “a win” for Neurocrine, “which has shown mixed results in its midstage pipeline, particularly the neuropsychiatry portfolio in-licensed from Takeda.”
In 2020, Neurocrine sought to diversify its research by licensing seven psychiatry drugs from Takeda. The deal carried an upfront payment of $120 million, and dangled another $1.9 billion that hinged on the drug programs hitting certain development and commercial milestones. Less than a year after the deal closed, one of its central assets, a therapy called luvadaxistat, failed a mid-stage study of schizophrenia patients.
The setback didn’t deter Neurocrine, however. It’s currently evaluating luvadaxistat for the treatment of cognitive impairment associated with schizophrenia. And in late 2021, the company secured rights to another crop of experimental psychiatry drugs through a licensing agreement with Sosei Heptares — which has since rebranded as Nxera Pharma.
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