Neurocrine Biosciences Shares Positive Phase 2 Results for Depression Treatment

A recent study by Neurocrine Biosciences, Inc. revealed promising results for an experimental drug, NBI-1065845, aimed at treating adults with major depressive disorder (MDD). The Phase 2 SAVITRI™ trial, a randomized, double-blind, placebo-controlled study, evaluated the drug's effectiveness and safety. The results showed that NBI-1065845, taken orally once daily, significantly improved depression symptoms based on the Montgomery Åsberg Depression Rating Scale (MADRS) scores.

Key findings indicated that the primary endpoint was met with a notable reduction in the MADRS score at Day 28. Additionally, secondary endpoints, including further reductions at Day 56, were also achieved. Specifically, one dose of NBI-1065845 resulted in a MADRS score improvement over placebo by -4.3 at Day 28 and -7.5 at Day 56. Another dose showed a trend toward improvement with a reduction of -3.0 at Day 28 and -3.6 at Day 56, though these latter figures were not statistically significant.

The trial included 183 adult participants diagnosed with MDD who had not responded adequately to their current antidepressant treatments. NBI-1065845, an investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM), aims to address the gap in effective treatments for these patients. Overall, the drug was well-tolerated, with headache being the most common adverse event, and no deaths or serious adverse events were reported, ensuring a favorable safety profile.

These results suggest that NBI-1065845 could become a pioneering treatment for MDD, offering new hope to those who suffer from persistent symptoms despite existing therapies. The findings from the SAVITRI study are promising enough for Neurocrine Biosciences to plan discussions with the FDA to advance to Phase 3 trials.

Neurocrine’s Chief Medical Officer, Eiry W. Roberts, M.D., emphasized the potential impact of NBI-1065845, noting that it could significantly improve the lives of millions who endure debilitating symptoms from MDD. Further data from the SAVITRI study is expected to be presented at upcoming scientific conferences, providing additional insights into the drug's efficacy and safety.

Neurocrine Biosciences' collaboration with Takeda has been instrumental in developing this promising treatment. Under their partnership, Neurocrine is responsible for the drug's development and commercialization, while Takeda supports these efforts through strategic collaboration.

MDD, a serious mental health condition characterized by prolonged depressive moods, loss of interest in daily activities, and difficulty in concentration, affects over 21 million people in the U.S. alone. With approximately one-third of MDD patients not responding to current treatments, the development of new therapeutic options like NBI-1065845 is crucial.

Neurocrine Biosciences focuses on developing therapies for neurological, neuroendocrine, and neuropsychiatric disorders. With a robust portfolio of FDA-approved treatments and ongoing clinical research, the company aims to address the significant unmet needs in these therapeutic areas.