Neurocrine Biosciences reported that its pill for major depressive disorder reduced scores on a depression severity scale at about one month in a Phase 2 trial.
In the SAVITRI study, 183 adult participants were assigned either Neurocrine’s treatment, known as NBI-1065845, or a placebo tablet.
Patients who received Neurocrine’s pill saw a statistically significant reduction in their scores compared to baseline on the Montgomery-Åsberg Depression Rating Scale at both 28 days and 56 days, meeting the primary and key secondary endpoints, respectively, in the mid-stage study.
Phase 2 participants had previously been treated with at least one antidepressant and saw inadequate improvement in their current depressive episode.
Neurocrine’s shares $NBIX jumped 5% on the news.
“Expectations were very low,” Stifel analyst Paul Matteis wrote in a Tuesday morning investor note, but added that “in a vacuum, a novel MOA like this in MDD could have blockbuster potential.”
The pill boosts AMPA, which is an activator of a specific receptor in the brain. Neurocrine licensed the drug candidate from Takeda as part of a collaboration that began in 2022.
Despite the positive data, Matteis highlighted three key questions: “(1) which dose had the bigger effect? i.e. was the dose-response linear? (2) How confident can we be in safety? Sounds clean, but boosting AMPA poses seizure risk…and (3) how large was the placebo effect? Relevant for thinking about replicability.”
The company was vague about which dose in the Phase 2 trial did better.
Clik here to view.
Eiry RobertsNeurocrine tested both a low and high dose of its drug, but only one demonstrated a statistically significant improvement over placebo, with an average difference (adjusted for other variables) of -4.3 and -7.5 compared to placebo at days 28 and 56, respectively. The other dose demonstrated a trend toward significance, Neurocrine said, without specifying what low and high doses were used.
“We are not sharing that level of detail at this time for competitive reasons and to preserve the opportunity to extend our intellectual property,” said Tony Jewell, Neurocrine’s executive director of corporate communications, in an emailed statement about the dose levels.
The most common adverse event reported by patients was headache, and there were no serious adverse events in the study.
Neurocrine’s chief medical officer Eiry Roberts said in a statement that the company plans to meet with the FDA to discuss Phase 3 studies. The company said that additional data will be shared at a future medical meeting.
