- 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.
The Late-Breaking Abstract, entitled: "A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety, and Tolerability of Sonelokinab (M1095), an IL-17A/F Nanobody, in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: Results from 24 Weeks," will be presented today at 14:45 CET by internationally recognised dermatology expert Kim Papp, MD, PhD, FRCPC, President of Probity Medical Research and principal investigator of the study.
Commenting on the results, Dr Papp said: "The data generated from this study of sonelokinab, the first nanobody tested in psoriasis, are extremely encouraging. These data suggest sonelokinab may represent an important advance in the search for new and improved treatments for psoriasis. Our data reinforces the advantage of targeting both IL-17A and IL-17F. Psoriasis remains a serious condition affecting all aspects of patients' lives. The development of new therapies is an ongoing challenge. Should larger studies confirm the speed of effect, durability and tolerability of sonelokinab demonstrated in this study, sonelokinab could become an important addition in our arsenal of therapies intended to improve patients' lives. Sonelokinab could prove to be an advancement on existing therapies in the dermatologist's psoriasis armamentarium."
Allison Jeynes, MD, Chief Executive Officer of Avillion, added: "These positive results clearly highlight the potential of sonelokinab. The smooth running and rapid completion of the trial ahead of schedule exemplifies how we seek to add value to our in-licensed assets, in this case from Merck KGaA Darmstadt, Germany. We are grateful to the investigators and patients across North American 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.
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.
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.
Avillion offers pharma partners an innovative model providing additional funding and clinical development expertise, to maximise the potential of new and existing assets. With deal sizes ranging from $50M–$600M, Avillion takes on the full clinical and regulatory risk, focusing on the speed and quality of trial execution. Typically supporting programs post proof-of-concept through to registration and with an agnostic approach to therapy area, Avillion prides itself in adding value around operational expertise while being backed by established long-term investors.
Avillion was founded in 2012 and is backed by Abingworth and Blackstone Life Sciences (previously Clarus Ventures). Blackstone Life Sciences and Royalty Pharma funded the sonelokinab program
For more information, please visit us at www.avillionllp.com