Plazinemdor

The now-shuttered phase 2 study was evaluating the NR2B negative allosteric modulator alongside standard-of-care treatment to quickly reduce MDD symptoms. Novartis rolled the dice in 2020 with a $210 upfront acquisition of long-time neuroscience partner Cadent Therapeutics. But the bet seems to have come up empty, as the Swiss pharma discontinues a mid-phase major depressive disorder program.  The decision to shelve MIJ821 in patients with major depressive disorder (MDD) experiencing suicidal ideation with intent followed a “benefit-risk assessment of available data,” a spokesperson said in an emailed statement. “No new or changing safety signal was identified for study participants.” The now-shuttered phase 2 study was evaluating the NR2B negative allosteric modulator alongside standard-of-care treatment to quickly reduce MDD symptoms. According to ClinicalTrials.gov, the trial was set to wrap this past July. The spokesperson did not confirm if the study met its goal.  When Novartis acquired Cadent less than three years ago, the pharma took ownership of the company's crown jewel CAD-9303, an investigational schizophrenia med being studied in a phase 1 trial at the time, and movement disorder program CAD-1883.  However, neither one of the assets was ever publicly incorporated into Novartis' pipeline, the spokesperson confirmed to Fierce Biotech. Because plans were never announced for the two programs, the company didn't have an update to share on them, according to the Novartis spokesperson. That leaves one indication for MIJ821 in treatment-resistant depression, something Novartis has been testing since 2015—years before the acquisition—when it exclusively licensed the asset from Cadent. The intravenous injection is currently being tested in a phase 2 trial, according to Novartis’ pipeline, though the company declined to confirm the ongoing status of the study.  The Big Pharma will share an updated pipeline as part of its third-quarter earnings call on Oct. 24, the spokesperson said.  MIJ821 is Novartis’ only therapy in development for MDD. The rest of the company’s neuroscience portfolio focuses on migraines, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, progressive supranuclear palsy and spinal muscular atrophy.

Novartis has entered into a definitive agreement to acquire all of the outstanding capital stock of US-based neuroscience company Cadent Therapeutics for a total potential consideration of up to $770m. Under the deal, Cadent will receive an upfront payment of $210m and is eligible for milestone payments of up to $560m. With this acquisition, Novartis will gain complete rights to Cadent’s neuroscience portfolio, including its NMDAr programme, which features two clinical programmes – CAD-9303, an NMDAr positive allosteric modulator and MIJ-821, an NMDAr negative allosteric modulator that was licensed to Novartis in 2015. Additionally, Novartis will gain full rights to CAD-1883, a clinical-stage SK channel positive allosteric modulator. Currently, this Phase II asset is under analysis for movement disorders. The latest deal also comprises a buyout of milestones and royalties for MIJ821, which is presently in a Phase II trial overseen by Novartis and could be beneficial to many patients who do not respond to current depression therapies. Novartis Institutes for BioMedical Research (NIBR) president Jay Bradner said: “We are committed to changing the lives of patients suffering from serious neuropsychiatric disorders for which there are limited treatment options. “The Cadent acquisition follows a longstanding collaboration and shared ambition to bring forward novel neuropsychiatric medicines targeted at the root cause of disease.” Cadent and Novartis expect the transaction to close in the first quarter of next year. In a separate development, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to Novartis’ iptacopan (LNP023) for treating paroxysmal nocturnal hemoglobinuria (PNH) and Rare Pediatric Disease (RPD) Designation for treating C3 glomerulopathy (C3G). Thematic Reports Are you worried about the pace of innovation in your industry? GlobalData's TMT Themes 2021 Report tells you everything you need to know about disruptive tech themes and which companies are best placed to help you digitally transform your business. Find out more An orally administered drug, Iptacopan is a potent and highly selective factor B inhibitor of the alternative complement pathway. In November, Novartis and Mesoblast signed an exclusive agreement for the development, manufacture and commercialisation of the former’s mesenchymal stromal cell (MSC) product remestemcel-L.