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
- All Primary and Secondary endpoints met with high statistical significance
- Sonelokinab is a novel investigational IL-17 A/F Nanobody that neutralizes both
IL-17A and IL-17F
- Trial completed ahead of schedule under a co-development agreement between Avillion and Merck KGaA Darmstadt, Germany
LONDON, Oct. 29, 2020 /PRNewswire/ -- 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 that positive results of its Phase 2 trial of sonelokinab (M1095), a novel anti-IL 17 A/F Nanobody, in patients with chronic psoriasis will be presented today in a Late-Breaking News session at EADV (European Academy of Dermatology and Venereology) 2020 Virtual Congress (29-31 October 2020). Top-line results from this study were first announced on 10 September 2020. The trial was conducted by Avillion under a 2017 co-development agreement with Merck KGaA Darmstadt, Germany and completed ahead of schedule.
The trial evaluated four dose regimens of sonelokinab and included both placebo and an active control arm of the IL-17A inhibitor secukinumab. 313 patients were randomized (n=51–53 for each group) with demographic and baseline characteristics generally similar between arms. The trial was conducted at 47 investigator sites in North America and Europe.
The trial met its primary endpoint based on Investigator's Global Assessment (IGA) at week 12 with clinically meaningful and statistically significant results for all tested doses (p<0.001). All secondary endpoints – Psoriasis Area and Severity Index (or PASI 75, PASI 90, and PASI 100) at week 12 – were also met with high statistical significance (p≤0.002). Sonelokinab was also found to be generally well tolerated with a safety profile in line with other biologic therapies for psoriasis at all doses tested.
At the highest dose, sonelokinab provided rapid and meaningful responses including:
- PASI 90 responses in approximately 1/3 of patients at week 4
- PASI 90 responses in approximately 4 of 5 patients at week 12
- PASI 100 responses in half of patients at week 24
The majority of adverse events (AE) reported during the placebo-controlled period were mild to moderate. Approximately half of patients reported one or more AEs, with the most frequent (incidence ≥5%) being nasopharyngitis (13.5%) and pruritus (6.7%). Five patients treated with sonelokinab experienced serious AEs (none related to study drug) and three discontinued due to an AE.