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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.