Positive Phase 2 Results for NBI-1065845 in Adult Major Depression

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has unveiled positive top-line results from its Phase 2 SAVITRI™ trial. This study, employing a randomized, double-blind, and placebo-controlled design, evaluated the efficacy and safety of NBI-1065845 in adult patients grappling with major depressive disorder (MDD). NBI-1065845 is an investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) being developed as a potential treatment for MDD patients who have not responded to at least one antidepressant during their current depressive episode.

The study successfully met its primary and key secondary endpoints, showcasing that once-daily oral administration of NBI-1065845 led to statistically significant improvements from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at both Day 28 (primary endpoint) and Day 56 (secondary endpoint). In the analysis dataset, the least squares (LS) mean differences from baseline in MADRS total scores for NBI-1065845 were as follows:

  • One dose demonstrated a significant improvement over placebo of -4.3 (p-value = 0.0159) and -7.5 (p-value = 0.0016) at Day 28 and Day 56, respectively.
  • The other dose also showed a trend toward improvement over placebo of -3.0 (p-value = 0.0873) and -3.6 (p-value = 0.1082) at Day 28 and Day 56, respectively.

NBI-1065845 demonstrated generally good tolerability, with headache being the most common adverse event. The adverse event profile for both doses of NBI-1065845 was comparable to placebo, and there were no deaths or serious adverse events reported. Discontinuation rates remained low throughout the study.

Dr. Eiry W. Roberts, Chief Medical Officer at Neurocrine Biosciences, emphasized, “Many millions of people living with major depressive disorder do not benefit fully from currently available treatments and experience persistent debilitating symptoms. NBI-1065845 has the potential to be a first-in-class treatment to alleviate many of these symptoms of MDD. The Phase 2 data from the SAVITRI study are very encouraging, and we look forward to meeting with the FDA to discuss a path into Phase 3 studies.”

Further data from the SAVITRI study will be presented at an upcoming scientific conference.

The Phase 2 SAVITRI™ study is a double-blind, placebo-controlled investigation aimed at evaluating the efficacy and safety of investigational NBI-1065845 in adult patients with MDD. The study enrolled 183 adults with a primary diagnosis of MDD who had inadequate responses to current antidepressant treatment.

NBI-1065845 is a potential first-in-class, investigational AMPA positive allosteric modulator (PAM) being developed as a potential treatment for patients with inadequate response to treatment in MDD.

In 2020, Neurocrine Biosciences and Takeda (TSE:4502/NYSE:TAK) formed 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). Under the agreement, Neurocrine Biosciences is responsible for developing and commercializing all compounds included in the collaboration. For NBI-1065845 and NBI-1065846, Takeda may opt out of a 50:50 profit share at certain development events on a program-by-program basis.

MDD is a mental health disorder characterized by persistent depressed mood, loss of interest, lack of enjoyment in daily activities, poor concentration, and decreased energy. MDD is one of the leading causes of disability, affecting more than 21 million people in the U.S. It is estimated that roughly one-third of people living with MDD do not respond to available antidepressants.

Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s portfolio includes FDA-approved treatments for various conditions, as well as a robust pipeline with multiple compounds in mid- to late-phase clinical development across core therapeutic areas. Neurocrine Biosciences aims to alleviate the burden of debilitating diseases and disorders through relentless pursuit of innovative treatments.

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