First patient dosed in EXIST Phase 2a study in Parkinson's disease
- BioArctic AB has dosed the first patient in the EXIST Phase 2a study for Parkinson's disease.
- The study evaluates exidavnemab, a monoclonal antibody targeting aggregated α-synuclein.
- EXIST is a randomized, double-blind, placebo-controlled study with 24 patients in Europe.
- The study will assess safety, tolerability, and biomarkers in plasma, CSF, and digital measurements.
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Muna Therapeutics announces strategic alliance with GSK to accelerate development of novel treatments for Alzheimer's disease
- Muna Therapeutics and GSK have formed a research alliance to identify and validate novel drug targets for Alzheimer's disease.
- The collaboration will utilize Muna's MiND-MAP platform, which applies spatial transcriptomics to brain samples from various patient groups.
- Muna will receive an upfront payment of €33.5 million from GSK, with potential milestone payments up to €140 million per target.
- GSK will lead drug development, preclinical activities, clinical development, manufacturing, and commercialization of validated targets.
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Leqembi approved for the treatment of early Alzheimer's disease in Mexico
- The Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved Leqembi (lecanemab) for early Alzheimer's disease.
- Leqembi is a monoclonal antibody that targets amyloid-beta aggregates, reducing both protofibrils and plaques in the brain.
- Approval is based on the Phase 3 Clarity AD study, which showed statistically significant results in slowing disease progression.
- Leqembi is already approved in several countries, including the U.S., Japan, and China, and is under review in 16 other regions.
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Nkarta announces IND clearance for trial in myasthenia gravis and opens enrollment for Ntrust-2
- Nkarta has received IND clearance for an investigator-sponsored trial (IST) to evaluate NKX019 in myasthenia gravis.
- Ntrust-2 trial is now open for enrollment, targeting systemic sclerosis, myositis, and ANCA-associated vasculitis.
- NKX019 is an allogeneic CAR NK-cell therapy aimed at depleting CD19-positive cells in B-cell mediated diseases.
- Preliminary data from Ntrust-1 and Ntrust-2 trials are expected in 2025.
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Facet Life Sciences named regulatory partner for Cybin's neuropsychiatry therapeutics development pipeline
- Facet Life Sciences will serve as the US regulatory partner for Cybin Inc., a neuropsychiatry company.
- The collaboration focuses on developing treatments for mental health conditions like Major Depressive Disorder and Generalized Anxiety Disorder.
- Facet will provide regulatory guidance for Cybin's therapies, including CYB003, which is in Phase 3 development.
- CYB003 has received FDA Breakthrough Therapy Designation for the treatment of major depressive disorder.
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