Data published in The Lancet show that the Trispecific Nanobody “totally clears skin in almost 6 out of 10 patients” with moderate to severe psoriasis
 

MoonLake Immunotherapeutics has announced publication of Phase IIb study results for its Tri-specific Nanobody sonelokimab in The Lancet, which indicate the drug's promise in moderate to severe psoriasis.

Sonelokimab is a unique, small-sized, 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.

The randomised, double-blind, placebo controlled, multicentre, Phase IIb study was designed to assess efficacy, safety and tolerability of the treatment in subjects with moderate-to-severe chronic plaque-type psoriasis. 

The trial enrolled 313 patients (age 18-75) with chronic plaque psoriasis for at least six months, with an Investigator Global Assessment (IGA) score =3, involved body surface area =10%, and Psoriasis and Severity Index (PASI) =12 at screening and at baseline. 

Patients were randomised to one of four dose regimens of sonelokimab, or a placebo comparator arm, or a reference arm (secukinumab).

Dosages up to 120mg showed “rapid and significant clinical benefit compared with placebo”, while, in the highest dosage group, 57% achieved total skin clearance (PASI 100 response) after 24 weeks, the firm noted.

Also, rapid response was demonstrated with one of three patients already achieving almost clear skin (PASI 90 response) by week 4, while analysis of an individualised dosing scheme including off-drug periods in controlled patients showed durable responses over one year. 

On the safety side, sonelokimab was generally well tolerated with a profile similar to the active control, secukinumab, and an overall candida rate of 7.4%. 

“Sonelokimab is a remarkable Nanobody with game-changing potential in the treatment of a range of IL-17A/F-driven inflammatory diseases. This study shows very high response levels in the model disease psoriasis, with a favorable benefit-safety profile,” commented investigator Kristian Reich MD, PhD, chief scientific officer and co-founder of MoonLake.