Zigakibart
- Generic Name
- Zigakibart
Novartis and Apellis Advance C3G Therapies Towards FDA Submission
• Novartis' Fabhalta (iptacopan) demonstrated significant proteinuria reduction in the Phase III APPEAR-C3G trial, meeting its primary endpoint and supporting regulatory submissions.
• Apellis' Empaveli (pegcetacoplan) showed a substantial reduction in proteinuria and C3c deposit clearance in the Phase III VALIANT trial, indicating early efficacy in C3G patients.
• Nephrologists express a strong interest in new C3G therapies that can slow eGFR decline and reduce proteinuria, addressing the urgent need for innovative treatments.
• Spherix data suggests treatment preferences may be influenced by administration route, with Fabhalta's oral administration potentially offering an advantage.
Fabhalta Demonstrates Sustained Efficacy in Phase 3 Trial for C3 Glomerulopathy
• Novartis' Fabhalta (iptacopan) shows clinically meaningful proteinuria reduction in C3 glomerulopathy (C3G) patients over 12 months in the Phase 3 APPEAR-C3G study.
• The study demonstrated a statistically significant 35.1% reduction in proteinuria at six months compared to placebo, with sustained effects observed throughout the trial.
• Fabhalta also improved estimated glomerular filtration rate (eGFR) slope, indicating a potential benefit in slowing kidney function decline in C3G patients.
• Regulatory submissions for Fabhalta in C3G are completed in the EU, China, and Japan, with a US submission expected by the end of the year.
Fabhalta Demonstrates Sustained Efficacy in Phase III C3 Glomerulopathy Trial
• Novartis' Fabhalta (iptacopan) shows sustained proteinuria reduction at 12 months in patients with C3 glomerulopathy (C3G) in the Phase III APPEAR-C3G trial.
• The study indicates improvement in estimated glomerular filtration rate (eGFR) slope upon Fabhalta initiation, suggesting a positive impact on kidney function.
• Fabhalta, an oral alternative complement pathway inhibitor, maintains a favorable safety profile with no new safety signals identified during the trial.
• Regulatory submissions for Fabhalta in C3G are completed in the EU, China, and Japan, with submissions expected in the US by the end of the year.
Otsuka's Sibeprenlimab Shows Positive Phase 3 Interim Results for IgA Nephropathy
• Otsuka Pharmaceutical's sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatinine ratio (uPCR) compared to placebo.
• The Phase 3 VISIONARY trial met its primary endpoint after nine months of treatment in adults with IgA nephropathy.
• Otsuka plans to discuss the interim results with the FDA, potentially leading to an accelerated regulatory submission for sibeprenlimab.
• Sibeprenlimab targets APRIL, a key factor in the immune pathogenic cascade of IgA nephropathy, offering a potential new therapeutic strategy.
Purespring Therapeutics Secures $105M to Advance IgAN Gene Therapy into Phase I/II Trials
• Purespring Therapeutics has secured $105 million in Series B funding to advance its lead candidate, PS-002, a gene therapy for IgA nephropathy (IgAN).
• PS-002 is an adeno-associated viral (AAV) gene therapy designed to target podocytes, specialized kidney cells, aiming to reduce inflammation and kidney dysfunction in IgAN patients.
• The funding will support the launch of a Phase I/II clinical trial for PS-002, addressing the critical unmet need for effective treatments beyond dialysis and transplantation in chronic kidney disease.
• Purespring's platform, FunSel, identifies effective treatments from a library of AAV vectors, showcasing potential for treating various kidney diseases by targeting specific genes.
FDA Grants Full Approval to Travere's Filspari for IgA Nephropathy
• The FDA granted full approval to Travere Therapeutics' Filspari (sparsentan) for IgA nephropathy, allowing broader use for patients at risk of disease progression.
• The approval was based on the PROTECT study, which demonstrated Filspari significantly slowed kidney function decline over two years compared to irbesartan.
• Filspari is now positioned as a foundational, non-immunosuppressive treatment option, potentially replacing the current standard of care for IgAN patients.
• The label update removes a specific urine protein level requirement, expanding the eligible patient population and increasing Filspari's market potential.
FDA Grants Accelerated Approval to Novartis' Fabhalta (Iptacopan) for IgA Nephropathy
• The FDA has granted accelerated approval to Fabhalta (iptacopan) for reducing proteinuria in adults with primary IgA nephropathy (IgAN).
• Fabhalta is the first complement inhibitor approved for IgAN, targeting the alternative complement pathway to reduce kidney damage.
• Phase III trial data showed a 44% reduction in proteinuria with Fabhalta compared to a 9% reduction with placebo.
• Continued approval may depend on verifying clinical benefits in ongoing trials assessing kidney function decline.
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