Novartis has made the decision to discontinue a mid-phase program aimed at treating major depressive disorder (MDD) with the investigational compound MIJ821. The termination of this program, which was in phase 2 and focused on MDD patients experiencing suicidal ideation with intent, followed a comprehensive evaluation of available data. Notably, there were no new or changing safety concerns identified for the study participants.
The phase 2 study, which combined MIJ821, an NR2B negative allosteric modulator, with standard-of-care treatment to expedite the reduction of MDD symptoms, had been scheduled to conclude in July, although it is not confirmed whether it achieved its objectives.
Novartis’s acquisition of Cadent Therapeutics in 2020 included the investigational schizophrenia medication CAD-9303 and the movement disorder program CAD-1883. However, neither of these assets was publicly integrated into Novartis’s pipeline. Since no formal plans were unveiled for these two programs, there is no updated information available on their status.
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This leaves MIJ821 with one remaining indication in the treatment of treatment-resistant depression, an area Novartis has been exploring since 2015, well before the acquisition of Cadent. The compound is currently undergoing evaluation in a phase 2 trial, although the company has not confirmed the ongoing status of this study.
Novartis plans to provide an updated pipeline report during its third-quarter earnings call scheduled for October 24.
MIJ821 currently stands as Novartis’s sole therapy in development for major depressive disorder. The company’s broader neuroscience portfolio encompasses research and development efforts in various areas, including migraines, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, progressive supranuclear palsy, and spinal muscular atrophy.
