MoonLake Immunotherapeutics announces publication in The Lancet of impressive Phase 2b data showing its Tri-specific Nanobody Sonelokimab totally clears skin in almost 6 out of 10 patients with moderate to severe psoriasis

• Sonelokimab showed significant clinical benefit with rapid onset and a good safety profile, with clear skin (PASI 100) achieved in up to 57% of patients at Week 24 and sustained responses over 52 weeks
• First Phase 2 evaluation of a Nanobody IL-17A/F inhibitor in psoriasis included secukinumab, an IL-17A inhibitor, as active control
• Unique, small size Nanobody Sonelokimab provides balanced inhibition of IL-17A and IL-17F and has an albumin binding site which may enable deep tissue penetration in skin and joints
• MoonLake plans to accelerate Sonelokimab's development program in inflammatory diseases driven by IL-17A and F, like psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and psoriasis

ZUG, Switzerland, May 6, 2021 /PRNewswire/ -- MoonLake Immunotherapeutics AG, a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory skin and joint diseases, today announced that full results of a Phase 2b study of its Tri-specific Nanobody Sonelokimab were published in The Lancet. Sonelokimab is an investigational IL-17A/IL-17F inhibitor with an albumin binding site, which has the potential to facilitate deep tissue penetration in the skin and joints. It has clinically demonstrated potential to allow better disease control in dermatology and rheumatology patients. Sonelokimab showed impressive efficacy with a favorable safety profile, and numerically outperformed active control secukinumab.

In the study, dosages up to 120 mg showed rapid and significant clinical benefit compared with placebo. In the highest dosage group, almost 6 out of 10 patients (57%) achieved total skin clearance (PASI 100 response) after 24 weeks. Rapid response was demonstrated with one of three patients already achieving almost clear skin (PASI 90 response) by week 4. Analysis of an individualized dosing scheme including off-drug periods in controlled patients revealed durable responses over one year. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab, and an overall candida rate of 7.4%. Although the highest dosage and schedule could be used for future clinical studies, additional assessment and modelling may aid in the final selection of the optimal dosage and schedule. The trial was conducted by Avillion LLP under a 2017 co-development agreement with Merck KGaA, Darmstadt, Germany.