NBI-1070770 is a novel, selective, and orally active, negative allosteric modulator.
The first patient has been randomized in a Phase II clinical trial which is evaluating NBI-1070770 in adults with major depressive disorder, according to a press release.1 Neurocrine Biosciences’ NBI-1070770 is a novel, selective, and orally active, negative allosteric modulator (NAM) of the NR2B subunit-containing N-methyl-D-aspartate (NMDA NR2B) receptor.
The Phase II trial (NCT06267846) is multi-center, randomized, double-blind, placebo-controlled study that will enroll approximately 72 adults and is being conducted at centers throughout the United States. It will evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to a placebo on improving symptoms of depression based on measurements by the Montgomery-Åsberg Depression Rating Scale.
The study is estimated to be completed in December 2025, with a primary completion in September 2025.
According to the National Institute of Mental Health, major depression is one of the most common mental disorders in the United States. Among US adults aged 18 or older in 2021, an estimated 21.0 million had at least one major depressive episode. This number represented 8.3% of all US adults.2
"Based upon our Phase I 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," Eiry W. Roberts, MD, chief medical officer of Neurocrine Biosciences said in the press release. "The selectivity of NBI-1070770 for the NMDA NR2B receptor has the potential to benefit patients who have moderate to severe depression."
1. Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder. News release. April 3, 2024. Accessed April 5, 2024. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-first-patient-dosed-in-phase-2-clinical-study-evaluating-nbi-1070770-in-adults-with-major-depressive-disorder-302106187.html
2. Major Depression. National Institute of Mental Health. Updated July 2023. Accessed April 5, 2024. https://www.nimh.nih.gov/health/statistics/major-depression
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.