Positive results from Avillion's Phase 2 trial of sonelokinab (M1095) in chronic psoriasis to be presented today in Late-Breaking News Session at EADV 2020 Virtual - Seite 3

About Psoriasis

Psoriasis is a chronic, relapsing, inflammatory skin disease that affects approximately 8 million people in the US and 125 million worldwide¹; 2-3 % of the total population have psoriasis, according to the World Psoriasis Day consortium. The exact causes leading to the development of psoriasis are not known yet, but some factors have been shown to play an important role, such as genetic predisposition or the presence of other diseases (comorbidities) or risk factors. Various treatments are available, but there is not yet a definite cure, meaning that psoriasis patients require a lifelong treatment. Psoriasis can begin at any age, and people affected are at an increased risk of developing other serious health conditions. Psoriasis has a significant impact on quality of life and on psychological health.

¹ National Psoriasis Foundation. Statistics. https://www.psoriasis.org/content/statistics. Accessed October 2020

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 sonelokinab's 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
• 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 (n=51–53 for each group) exploring four dose regimens with sonelokinab, or a placebo comparator arm or an active reference arm (secukinumab).

The study consisted of a 12-week placebo-controlled period, followed by a 12-week dose optimization part and a dose individualization part from week 24–52.

During the first 12 weeks, patients received placebo, sonelokinab 30 mg, 60 mg, or 120 mg at weeks 0, 2, 4, and 8 (denoted normal load); sonelokinab 120 mg at weeks 0, 2, 4, 6, 8 and 10 (denoted augmented load); or secukinumab 300 mg (weeks 0, 1, 2, 3, 4 and 8). 

From weeks 12–24 (maintenance/escalation), patients randomized to 30 or 60 mg sonelokinab with an IGA score of >1 at week 12 were escalated to 120 mg once monthly (q4w), those receiving placebo were switched to 120 mg (weeks 12, 14, 16 and q4w), and patients receiving 120 mg normal load) and 120 mg augmented load) were treated q8w and q4w, respectively.