Brepocitinib
- Generic Name
- Brepocitinib
Phase 3 Trial Shows Promising Results for Novel Encapsulated Cell Therapy in MacTel Treatment
• Phase 3 clinical trials of NT-501, an encapsulated cell therapy delivering CNTF, demonstrated significant reduction in disease progression for macular telangiectasia type 2 patients, with up to 52% reduction in ellipsoid zone loss.
• The innovative implantable device, developed by Neurotech, maintains long-term viability with CNTF production documented for up to 14.5 years, offering a potential alternative to frequent intravitreal injections.
• FDA review of the therapy is currently underway with a PDUFA date set for March 18, 2025, marking a potential breakthrough in MacTel treatment.
Navigating Clinical Trials in Inflammatory Bowel Disease: A Modern Interpretation
• Modern randomized controlled trials (RCTs) in IBD face challenges including trial design, patient selection, and endpoint assessment, impacting result interpretation.
• Placebo response rates in IBD trials can be substantial, necessitating careful consideration in trial design and analysis to accurately assess drug efficacy.
• Trial design should account for disease heterogeneity, prior treatment history, and patient-reported outcomes to reflect real-world clinical scenarios.
• Standardization of endpoints, such as endoscopic and histological healing, is crucial for comparing treatment efficacy across different IBD trials.
Brepocitinib Shows Promise in Non-Infectious Uveitis: Phase 3 Trial Initiated
• Priovant Therapeutics' brepocitinib demonstrated significant treatment failure reductions in the Phase 2 NEPTUNE trial for non-infectious uveitis.
• The CLARITY Phase 3 trial has been initiated to further evaluate brepocitinib's efficacy against non-anterior non-infectious uveitis, comparing 45mg dose to placebo.
• Brepocitinib received Fast Track Designation from the FDA, expediting its development for non-infectious uveitis due to unmet medical needs.
• The dual TYK2/JAK1 inhibitor showed a dose-dependent improvement in retinal vascular leakage, as measured by fluorescein angiography, in the NEPTUNE trial.
Drug Development Updates
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