Biopharmaceutical company Vanda Pharmaceuticals Inc (Nasdaq: VNDA) announced on Monday that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for imsidolimab, an IgG4 IL-36 receptor antagonist, for the treatment of generalized pustular psoriasis. Imsidolimab targets IL-36 receptor signalling, addressing regulatory deficiencies linked to IL36RN gene mutations commonly observed in patients with the disease.

The application is supported by positive data from the global Phase 3 GEMINI-1 and GEMINI-2 studies. Results showed a single intravenous dose of imsidolimab delivered rapid skin clearance, with clear or almost clear skin maintained during an approximately two-year maintenance period with monthly dosing. Programme data demonstrated a favourable safety profile with no clinically meaningful safety signals.

GEMINI-1 enrolled 45 patients randomised to 750 mg or 300 mg imsidolimab, or placebo, with 53% of treated patients achieving clear or almost clear skin at Week 4 compared with 13% on placebo. Responders entered GEMINI-2 for monthly subcutaneous maintenance dosing, where all patients on imsidolimab maintained disease control with no flares, versus a 63% flare rate in the placebo group.

Imsidolimab is being developed as an orphan therapy for generalised pustular psoriasis, a rare, chronic and potentially life-threatening autoinflammatory skin condition with significant unmet need. Regulatory and patent exclusivity is expected to extend into the late 2030s. Vanda Pharmaceuticals Inc holds exclusive global development and commercialisation rights under a licensing agreement with AnaptysBio Inc (Nasdaq: ANAB).