Positive
Significant improvement in skin clearance for patients receiving imsidolimab in the Phase 3 trials
Excellent maintenance of skin clearance with no flares in patients on monthly maintenance dosing of imsidolimab
Positive safety and tolerability profile with no treatment-related serious adverse events reported
Low incidence of infections, no cases of DRESS or GBS reported, and low incidence of anti-drug antibodies detected
Plan to out-license imsidolimab in 2024 to bring the therapy to patients with GPP
Negative
Some patients who received placebo in GEMINI-2 experienced flares and did not maintain clear skin
Need for further clinical data and regulatory approval before potential commercialization of imsidolimab