Ablynx announced that its partner, Merck KGaA, has presented new data from a Phase Ib study demonstrating strong efficacy with the bi-specific anti-IL-17A/F Nanobody® (M1095; ALX-0761) in patients with moderate-to-severe chronic plaque psoriasis. The results were presented at the 75th Annual Meeting of the American Academy of Dermatology Conference, taking place from 3-7 March 2017, in Orlando, Florida.
The Phase Ib study was a multi-centre, double-blind, randomised, placebo-controlled trial in 41 patients with moderate-to-severe chronic plaque psoriasis to evaluate the safety, tolerability and immunogenicity of multiple ascending doses of M1095, ranging from 30mg to 240mg administered subcutaneously on days 1, 15 and 29. The study also evaluated pharmacokinetic profiles and efficacy of multiple subcutaneous doses of M1095.
A reduction in disease activity, as measured by the Psoriasis Area Severity Index (PASI) and improvement in static Physician Global Assessment (sPGA) was seen for all doses of M1095 versus 0% for placebo. At day 85, all patients treated with 240mg M1095 experienced a 75% reduction in disease activity (PASI 75) and had clear or almost clear skin (PASI 90); moreover, 56% of patients in this highest dose group had clear skin (PASI 100). In addition, rapid onset of clinical effect was observed after the first administered dose and sustained through to completion of the study at day 85.
M1095 had a favourable safety and tolerability profile, with no treatment-related serious adverse events reported and no dose-dependent increase in frequency or severity of adverse events. There was no apparent effect of anti-drug antibodies on pharmacokinetics.
Dr. Edwin Moses, CEO of Ablynx, commented: “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. We were responsible for the discovery and some of the pre-clinical work and Merck KGaA is now responsible for the clinical development and commercialisation of this drug candidate. These initial clinical data are very encouraging compared to other psoriasis therapeutics commercially available, and in development. We believe that the results are a further validation of the enormous potential of the Nanobody platform to generate differentiating multi-specific drug candidates for the treatment of a wide range of diseases.”
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