ProMIS Neurosciences initiates Phase 1b clinical trial (PRECISE-AD) in Alzheimer’s disease
- ProMIS Neurosciences has started a Phase 1b trial for PMN310, targeting toxic amyloid-beta oligomers in Alzheimer's disease.
- The trial will assess safety, tolerability, and pharmacokinetics in 100 patients with mild cognitive impairment or early Alzheimer's over 12 months.
- PMN310 aims to reduce amyloid-related imaging abnormalities by avoiding interaction with plaque deposits.
- Interim data from the trial is expected in the first half of 2026.
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Passage Bio announces interim data from upliFT-D study in FTD-GRN
- PBFT02 showed durable increase in CSF PGRN levels and reduced plasma NfL levels, a biomarker for disease progression.
- Dose 2, 50% lower than Dose 1, is being evaluated to support regulatory strategy and dose exploration.
- 12-month data from Dose 1 and interim data from Dose 2 expected in 2H 2025; regulatory feedback on pivotal trial design anticipated in 1H 2026.
- Cash runway extended to 1Q 2027 by outsourcing analytical testing and reducing operating expenses.
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Acumen Pharmaceuticals publishes phase 1 INTERCEPT-AD study results
- Phase 1 INTERCEPT-AD study results published in the Journal of Prevention of Alzheimer’s Disease.
- Sabirnetug (ACU193) showed selective, dose-dependent target engagement of amyloid beta oligomers.
- Statistically significant reduction in amyloid plaques observed in higher dose cohorts.
- Phase 2 ALTITUDE-AD trial is ongoing, with enrollment completion expected in the first half of 2025.
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The New York Stem Cell Foundation partners with Janssen for neurodegenerative disease research
- The New York Stem Cell Foundation (NYSCF) has partnered with Janssen Research & Development to enhance drug discovery for neurodegenerative diseases.
- The collaboration will utilize NYSCF's AI-powered platform and automated cell culture systems to study diseases at a cellular level.
- NYSCF's technology enables large-scale disease modeling and drug screening using patient-derived stem cells.
- The partnership aims to accelerate the development of tailored treatments by identifying novel disease phenotypes and therapeutic targets.
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Intra-Cellular Therapies settles Caplyta patent litigation with Sandoz
- Intra-Cellular Therapies has settled a patent litigation with Sandoz regarding Caplyta (lumateperone).
- The litigation was due to Sandoz's application to market a generic version of Caplyta in the U.S.
- Sandoz can begin selling generic Caplyta from July 1, 2040, or earlier under certain conditions.
- The settlement will be submitted to the U.S. Federal Trade Commission and the Department of Justice.
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