Neurocrine Biosciences Inc NBIX revealed on Tuesday topline data for its Phase 2 SAVITRI study of NBI-1065845 in adult subjects with major depressive disorder (MDD).
In 2020, Neurocrine Biosciences and Takeda Pharmaceutical Company Limited TAK entered into a strategic collaboration to develop and commercialize compounds in Takeda’s early-to-mid-stage psychiatry pipeline, including an exclusive license to NBI-1065845 (TAK-653).
The study met its primary and key secondary endpoints, demonstrating that once-daily, oral administration of NBI-1065845 produced a statistically significant change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total score at both Day 28 (primary) and Day 56 (secondary).
In the full analysis data set, the least squares (LS) mean differences from baseline in MADRS total score for NBI-1065845 were:
One of the doses demonstrated improvement over the placebo of -4.3 (p-value = 0.0159) and -7.5 (p-value = 0.0016) at Day 28 and Day 56, respectively.
The other undisclosed dose did not achieve statistical significance but demonstrated a trend toward improvement over the placebo of -3.0 (p-value = 0.0873) and -3.6 (p-value = 0.1082) at Day 28 and Day 56, respectively.
NBI-1065845 was generally well tolerated.
The most common adverse event was headache. The adverse event profile for both doses of NBI-1065845 was comparable to the placebo. There were no deaths or serious adverse events.
The discontinuation rates were low throughout the study.
William Blair suggested the company’s recent update is a positive development, especially considering its inconsistent performance in the midstage pipeline, particularly with the neuropsychiatry portfolio obtained from Takeda.
Although depression remained challenging to address due to placebo effects, the update indicated the potential for a significant sales opportunity exceeding $1 billion for a new antidepressant mechanism.
Despite this, there is cautious optimism, although replication in pivotal studies is crucial.
Investors are also eagerly awaiting updates on the M4-agonist ‘568 program, given positive results from similar programs in the industry.
In the meantime, the company’s value largely depends on Ingrezza revenue, with anticipation for the first-quarter earnings call on May 1.
William Blair maintained an Outperform rating on Neurocrine.
NBIX Price Action: NBIX shares are up 4.29% at $139.31 at the last check Tuesday.
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