Avillion announces positive top-line results of Phase 2 trial of sonelokinab (M1095), an anti-IL-17 A/F Nanobody®, in chronic psoriasis
Trial conducted under a co-development agreement between Avillion and Merck KGaA Darmstadt, Germany
London, UK, 10 September 2020 – Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announces the successful completion and positive top-line results of its Phase 2 trial of sonelokinab (M1095), an investigational anti-IL-17 A/F Nanobody®, in patients with moderate to severe chronic plaque-type psoriasis. The study evaluated four dose regimens of sonelokinab, placebo and a reference arm of secukinumab.
The trial was conducted by Avillion under a 2017 co-development agreement with Merck KGaA Darmstadt, Germany under which Avillion would undertake and finance the clinical development of sonelokinab of Merck KGaA Darmstadt, Germany, from Phase 2 through Phase 3 to regulatory submission.
After completing enrolment of 313 patients, ahead of schedule, the trial met its primary endpoint based on Investigator's Global Assessment (IGA) at week 12, and secondary endpoints (Psoriasis Area and Severity Index or PASI 75, PASI 90, and PASI 100 at week 12) with high statistical significance (p<0.001). Sonelokinab was also found to be generally well tolerated and in line with other biologic therapies for psoriasis at all doses tested.
The data are being prepared for presentation at an upcoming international conference and for publication in a peer-reviewed medical journal.
“This Phase 2 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 2 results we will explore partnership options to rapidly deliver this promising new therapy to patients living with psoriasis.”
Kim Papp, MD, PhD, FRCPC, President of Probity Medical Research and an internationally recognised dermatology expert, commented: “We have made significant advances in the treatment of psoriasis. Despite these advances, the search for new and improved therapies is essential as the impact on all aspects of patients’ lives – physical, emotional and social – is relentless. And this study is a step forward in our ongoing search. I am impressed with the conduct of the study. I am impressed with the quality of the data for this study of sonelokinab. The initial data is exciting as it holds out the potential to further advance the treatment of psoriasis. I am very excited at the prospect of seeing further data from larger pivotal studies.”
Allison Jeynes, MD, Chief Executive Officer of Avillion, added: “The timely and successful completion of this clinical trial with sonelokinab provides further validation of Avillion’s innovative business model and ability to flawlessly execute its clinical development plans and add value to our partners’ pipelines. We are delighted with the progress made and the trust built in our collaboration with Merck KGaA Darmstadt, Germany.”
About the sonelokinab (M1095) Phase 2 trial (NCT identifier NCT03384745)
The trial is a Phase 2b randomized, double-blind, placebo controlled, multi-centre study designed to assess its efficacy, safety and tolerability 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's Global Assessment (IGA) score ≥3, involved body surface area (BSA) ≥10%, and Psoriasis Area and Severity Index (PASI) ≥12 at screening and at baseline.
Patients were randomised to one of four experimental arms exploring four dose regimens with sonelokinab, or a placebo comparator arm or a reference arm (secukinumab).
The primary endpoint was achievement of an IGA response (i.e. IGA score of 0 or 1, with an IGA reduction of at least 2 points from baseline) vs. placebo. IGA is the Investigator's assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale).
Secondary endpoints included PASI 75 (reduction in PASI burden by at least 75%), PASI 90 (reduction in PASI burden by at least 90%) and PASI 100 (psoriasis has completely cleared) at week 12 compared to baseline.
The trial was conducted at 47 investigator sites in North America and Europe.
About sonelokinab (M1095)
The Anti-IL-17 A/F Nanobody® sonelokinab is an investigational bi-specific half-life-extended Nanobody that is thought to neutralise both IL-17A and IL-17F with the potential to treat inflammatory diseases. Due to the small size and unique structure of Nanobodies®, they could be an ideal building block for a new generation of novel biological drugs.
Merck KGaA Darmstadt, Germany acquired full, exclusive rights to anti-IL-17 A/F Nanobody® through a global development and commercialisation deal with Ablynx in 2013. Avillion entered into a co-development agreement with Merck KGaA Darmstadt, Germany for the Phase 2 and Phase 3 development of sonelokinab in March 2017.