First-of-kind Guillain-Barré drug switches off part of immune system
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- Tanruprubart, a monoclonal antibody from Annexon Biosciences, blocks the C1q protein to switch off the classical complement pathway that mistakenly attacks nerves in Guillain-Barré syndrome
- The late-stage trial in Bangladesh and the Philippines enrolled 241 recently diagnosed patients; treated patients required 28 fewer days of mechanical ventilation, 7 fewer ICU days, and walked independently 31 days earlier than placebo
- Annexon Biosciences submitted tanruprubart for European Medicines Agency approval and plans to file with the FDA in the next few months, hoping for approval in the first part of next year
- The single infusion produced no serious side effects, with Doug Love of Annexon noting that avoiding chronic immune suppression limited infection risk
- Existing GBS treatments—plasma exchange and intravenous immunoglobulin—have been unchanged for roughly 25-30 years, and tanruprubart would be the first targeted therapy for the condition if approved
- Stefan Blum at Princess Alexandra Hospital in Brisbane cautioned that the trial's Bangladesh and Philippines sites may limit applicability, since GBS is typically triggered by Campylobacter jejuni in developing countries but viral infections in developed nations
Why it matters: If approved, tanruprubart would end a roughly 25-30 year treatment drought for Guillain-Barré syndrome, giving the approximately 8,000 US patients diagnosed annually a targeted alternative to plasma exchange and IVIG. Annexon submitted for EMA approval, with a decision sought in the first part of next year; FDA filing is planned for the next few months.
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