Merck reports positive data from Phase Ib trial of M1095 in psoriasis patients

Ablynx’s partner Merck has presented new data from a Phase Ib trial of the bi-specific anti-IL-17A/F Nanobody (M1095; ALX-0761) in patients with psoriasis.

The multi-centre, double-blind, randomised, placebo-controlled Phase Ib trial was carried out in 41 patients with moderate-to-severe chronic plaque psoriasis to evaluate the safety, tolerability and immunogenicity of multiple ascending doses of M1095.

As part of the study, pharmacokinetic profiles and efficacy of multiple subcutaneous doses of M1095 were also evaluated.

Ablynx CEO Dr Edwin Moses said: "This Nanobody was developed as part of a deal we signed with Merck KGaA in 2008 and was the first functional bi-specific Nanobody to reach the clinic.

“This initial clinical data is very encouraging compared to other psoriasis therapeutics commercially available, and in development."

The trial found a reduction in disease activity for all M1095 doses as measured by the Psoriasis Area Severity Index (PASI) and an improvement in static Physician Global Assessment (sPGA).

M1095 had a favourable safety and tolerability profile, and no treatment-related serious adverse events were reported.

M1095 neutralises the pro-inflammatory cytokines IL-17A and IL-17F, which are each expressed at inflammatory sites, and have been implicated in the pathogenesis of psoriasis and several auto-immune disorders.

Merck is now responsible for the clinical development and commercialisation of M1095 and Ablynx will receive milestones and royalties as the programme progresses.

PASI is used to measure the severity of psoriasis and assesses treatment efficacy by measuring the reduction in redness, scaling and thickness of psoriatic plaques and the extent of involvement in each region of the body.