Imsidolimab

In GEMINI-1, GPPPGA scores of 0 or 1 at week 4 were achieved by 8 of 15 participants (53%) receiving 300 mg IV imsidolimab, 8 of 15 participants (53%) receiving 750 mg IV imsidolimab, and 2 of 15 participants (13%) receiving placebo. The publication reported P=0.023 for each imsidolimab comparison with placebo.

In the reported GEMINI-2 randomized maintenance comparison, 8 of 8 participants receiving imsidolimab and 2 of 8 receiving placebo maintained a GPPPGA score of 0 or 1. No participants receiving imsidolimab and 5 of 8 receiving placebo experienced a flare. The poster reported that no serious adverse events led to study treatment discontinuation or withdrawal. Separately, the phase 2 GALLOP publication reported serious adverse events in two participants and no deaths.