NBI-1065845 was generally well-tolerated, with headaches being the most common adverse event. Credit: chainarong06/Shutterstock.com.

Neurocrine Biosciences has announced positive topline data from its Phase II SAVITRI study, evaluating the efficacy and safety of NBI-1065845 in adults with major depressive disorder (MDD).

NBI-1065845 is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM). It is intended as a potential treatment for patients with an inadequate response to previous treatment for MDD.

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The Phase II SAVITRI study is a randomised, double-blind, placebo-controlled trial. It aims to assess the efficacy and safety of NBI-1065845 in adult subjects with MDD who have not responded adequately to antidepressant treatment.

The study, which enrolled 183 adults with a primary diagnosis of MDD, met its primary and key secondary endpoints.

It demonstrated that a once-daily oral administration of NBI-1065845 produced a statistically significant reduction from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) total score at both day 28 (primary) and day 56 (secondary).

One dosage of NBI-1065845 demonstrated an improvement over a placebo of -4.3 (p-value = 0.0159) at day 28 and -7.5 (p-value = 0.0016) at day 56.

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Another dosage showed a trend towards improvement, with a reduction of -3.0 (p-value = 0.0873) at day 28 and -3.6 (p-value = 0.1082) at day 56.

NBI-1065845 was generally well-tolerated, with headaches being the most common adverse event.

Neurocrine Biosciences chief medical officer Eiry W Roberts said: “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.”

Neurocrine is developing NBI-1065845 in a strategic collaboration with Takeda.

The two firms signed an agreement in 2020 to develop Takeda’s early-to-mid-stage psychiatry pipeline, including an exclusive licence for NBI-1065845 (TAK-653).

In October 2023, Neurocrine Biosciences reported positive top-line results from the Phase III CAHtalyst Pediatric study of crinecerfont for the treatment of congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.