Merck KGaA, Darmstadt, Germany Announces Positive Phase II Results for Investigational Sonelokinab (M1095) in Patients with Moderate to Severe Chronic Plaque-Type Psoriasis

• Merck KGaA, Darmstadt, Germany today announced positive top-line results from a Phase II study of sonelokinab (M1095), an investigational anti-IL-17 A/F Nanobody®, which neutralizes both IL-17A and IL-17F.

• Sonelokinab is an investigational IL-17 A/F Nanobody®, which neutralizes both IL-17A and IL-17F
• Phase II study was facilitated by Avillion as part of an innovative co-development model

DARMSTADT, Germany, Sept. 11, 2020 – Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced positive top-line results from a Phase II study of sonelokinab (M1095), an investigational anti-IL-17 A/F Nanobody®, which neutralizes both IL-17A and IL-17F, in patients with moderate to severe chronic plaque-type psoriasis. Currently there are no approved IL-17 A/F nanobodies. The Phase II study was completed through a co-development agreement with Avillion, first announced in 2017.

“This Phase II study was conducted by Avillion as part of an innovative co-development model and we thank them for their partnership and successful completion of this trial with high quality data,” said Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck KGaA, Darmstadt, Germany. “Given the encouraging Phase II results we will explore partnership options to rapidly deliver this promising new therapy to patients living with psoriasis.”

The randomized, double-blind, placebo controlled, multi-centre, Phase IIb study was designed to assess efficacy, safety, and tolerability of sonelokinab 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 randomized to one of four dose regimens of sonelokinab, or a placebo comparator arm, or a reference arm (secukinumab). The study met its primary endpoint of IGA response of at least 2 points reduction from baseline, and secondary endpoints of PASI with high statistical significance (p<0.001). The data are being prepared for presentation at an upcoming international conference and for publication in a peer-reviewed medical journal.

“The Phase II study results for sonelokinab provide valuable insights.  The onset of action and potential durable response of sonelokinab in psoriasis patients merits further characterization in a comprehensive Phase III program,” said Kim Papp, MD, PhD, FRCPC, Primary Investigator.

Merck KGaA, Darmstadt, Germany acquired full, exclusive rights to the anti-IL 17 A/F Nanobody® through a global development and commercialization deal with Ablynx (now Ablynx, a Sanofi Company) in 2013.