First Patient Dosed in Phase 2 Clinical Trial of NBI-1070770 for MDD

The first patient has been randomized in a phase 2 clinical trial (NBI-1070770-MDD2029) assessing the efficacy, safety, and tolerability of investigational compound NBI-1070770 in adults diagnosed with major depressive disorder (MDD).

NBI-1070770 is a novel, selective, orally active negative allosteric modulator (NAM) targeting the NR2B subunit-containing N-methyl-D-aspartate (NMDA NR2B) receptor.¹

“Based upon our phase 1 first-in-human study, we are excited to bring this novel oral compound, which acts through a clinically validated mechanism of action, into clinical development as a potential treatment for major depressive disorder,” said Eiry W. Roberts, MD, chief medical officer at NBI-1070770 developer Neurocrine Biosciences Inc, in a press release. “The selectivity of NBI-1070770 for the NMDA NR2B receptor has the potential to benefit patients who have moderate to severe depression.”

The phase 2 trial is a multi-center, randomized, double-blind, placebo-controlled study expected to enroll approximately 72 adults across various centers in the United States. Its primary objective is to evaluate the safety and efficacy of NBI-1070770 compared with placebo in improving depressive symptoms, as assessed by the Montgomery-Åsberg Depression Rating Scale.¹

In the trial, participants will be divided into 4 groups: 1 receiving a low dose of NBI-1070770, 1 receiving a medium dose of NBI-1070770, 1 receiving a high dose of NBI-1070770, and 1 receiving a matching placebo. The trial is currently enrolling at Neurocrine Clinical Sites in Gaithersburg, Maryland; Lemon Grove, California; Rogers, Arkansas; Hollywood, Florida; and Long Beach, California.²

The key inclusion criteria for participation in the trial include²:

• Participants must have a primary diagnosis of either recurrent MDD or persistent MDD.
• Participants who are currently undergoing pharmacological treatment for depression must have been taking their current antidepressant medication(s) for a minimum of 8 weeks prior to screening. They also must express willingness and ability to continue with their current antidepressant medication(s).
• Participants must demonstrate willingness and ability to adhere to all study procedures and restrictions throughout the duration of the trial.

The key exclusion criteria for participation in the trial include²:

1. Participants cannot be pregnant, breastfeeding, or planning to become pregnant during the study period.
2. Participants cannot have any unstable medical conditions or unstable chronic diseases.
3. Participants cannot have a history of neurological abnormalities.
4. Participants cannot have a current or past diagnosis of a psychiatric disorder other than MDD that was the primary focus of treatment.
5. Participants cannot have depressive symptoms that have previously shown nonresponse to an adequate course of treatment with electroconvulsive therapy.
6. Participants cannot have been diagnosed with any alcohol or substance use disorders.

For further details about the NBI-1070770-MDD2029 phase 2 clinical study, visit Clinicaltrials.gov.

Interested in learning more about the latest news in MDD and other mood disorders? In case you missed it, the March content theme in Psychiatric Times® was mood disorders including MDD, depression, and bipolar disorder. Here are some highlights from the month:

Neuromodulation Approaches to Depressive Disorders

BPL-003: Rapid, Durable Treatment for TRD Sees Positive Phase 2 Results

An Update on Bipolar I Disorder

Assessing, Treating, and Managing Spring Mania in Patients With Bipolar Disorder

Augmentation Strategies for Treatment-Resistant Depression

Transcranial Direct Current Stimulation for Major Depressive Disorder: A Look at Starstim

The Clubhouse Model for Depression and Serious Mental Illnesses

Neuromodulation for Depressive Disorders: Top 5 Takeaways

Evidence-Based Novel Therapies for Bipolar Depression: Top 5 Takeaways

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of psychiatric disorders at psychiatrictimes.com.

Note: This article was prepared with the assistance of ChatGPT.

References

1. Neurocrine Biosciences announces first-patient dosed in phase 2 clinical study evaluating NBI-1070770 in adults with major depressive disorder. BioSpace. News release. April 3, 2024. Accessed April 3, 2024. https://www.biospace.com/article/releases/neurocrine-biosciences-announces-first-patient-dosed-in-phase-2-clinical-study-evaluating-nbi-1070770-in-adults-with-major-depressive-disorder/

2. A study to evaluate the efficacy and safety of NBI-1070770 in adults with major depressive disorder. CTV. Updated March 25, 2024. Accessed April 3, 2024. https://ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-and-safety-of-nbi-1070770-in-adults-with-major-depressive-disorder