Clinical Trials

Date: 2017-03-06

Type of information: Presentation of results at a congress

phase: 1b

Announcement: presentation of results at the 75th Annual Meeting of the American Academy of Dermatology Conference

Company: Merck KGaA (Germany)

Product: M1095

Action mechanism:

• nanobody. The interleukin (IL)-17A/F bispecific Nanobody neutralizes the pro-inflammatory cytokines IL-17A and IL-17F, which are each expressed at inflammatory sites, and have both been implicated in the pathogenesis of psoriasis and several auto-immune disorders.  The bi-specific anti-IL-17A/F Nanobody (M1095) was discovered by Ablynx as part of a deal we signed with Merck KGaA in 2008. Merck KGaA is now responsible for the clinical development and commercialization of M1095 with Ablynx set to potentially receive milestones and royalties as the programme progresses.

Disease: psoriasis

Therapeutic area: Autoimmune diseases - Dermatological diseases

Country: Germany

Trial details: 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. (NCT02156466)  

Latest news:

• • On March 6, 2017, 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.
• 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.
• • On January 26, 2017, Ablynx announced that its partner, Merck KGaA has reported encouraging results from a study in psoriasis patients with the bi-specific Nanobody® anti-IL-17A/F (M1095). The trial was conducted in 41 patients with moderate-to-severe psoriasis with multiple ascending subcutaneous doses ranging from 30mg to 240mg administered on days 1, 15 and 29. The primary endpoints were safety, tolerability, immunogenicity and pharmacokinetics. Secondary endpoints were pharmacodynamics and efficacy. The doses of M1095 were well tolerated. No dose-dependent treatment-emergent adverse events were observed. Pharmacokinetic profiles demonstrated dose proportionality with the expected terminal half-life of ~11-12 days. There was no apparent effect of anti-drug antibodies on pharmacokinetics.
• A reduction in disease activity, as measured by Psoriasis Area Severity Index (PASI) and improvement in static Physician Global Assessment (sPGA) was seen for all doses of M1095. At day 85, for the three highest dose groups (60mg, 120mg, and 240mg); PASI-75 (75% or more reduction in disease activity) scores of 100% were achieved versus 0% for placebo. In addition, all dose levels of M1095 showed 88-100% of patients achieving a minimal or clear sPGA score at day 85 versus 0% for placebo. Rapid onset of clinical effect was observed after the first dose and sustained out through to the conclusion of the study at day 85.

 

Is general: Yes