Clinical TrialAug 6, 2026, 08:28 AM
Annexon Tanruprubart GBS Study Shows Rapid, Positive Responses
AI Summary
Annexon, Inc. announced positive early results from the first U.S. and European patient cohort of its open-label GBS FORWARD study for tanruprubart, an investigational therapy for Guillain-Barré syndrome (GBS). All ten patients demonstrated rapid, clinically meaningful improvement in strength and reduced disability within days of treatment, with outcomes reinforcing consistency with prior Phase 3 and real-world evidence studies. The company plans to use FORWARD data to support a Biologics License Application (BLA) submission targeted for Q4 2026, while the Marketing Authorisation Application (MAA) is already under review by the European Medicines Agency (EMA).
Key Highlights
- All 10 patients in the GBS FORWARD study showed rapid, clinically meaningful improvement in muscle strength within four days.
- Four bedbound patients walked with or without assistance between day two and eight.
- One patient requiring ventilation came off the ventilator within four days.
- Five other patients showed marked gains in function within 48 hours.
- Tanruprubart was generally well-tolerated, consistent with Phase 3 results.
- Results are consistent with previous Phase 3 and Real World Evidence studies.
- BLA submission for tanruprubart is targeted for Q4 2026.
- Marketing Authorisation Application (MAA) for tanruprubart is currently under review by the EMA.
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