Sonelokimab
Also known as: ALX-0761, M1095, Sonelokimab
Source Sonelokimab at Peptiology
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Summary
Sonelokimab (ALX‑0761, M1095) is an investigational trivalent nanobody that simultaneously binds interleukin‑17A, interleukin‑17F and human serum albumin. Delivered by subcutaneous injection, it has been evaluated in a phase 2b trial for moderate‑to‑severe plaque psoriasis and appears in network meta‑analyses of psoriasis and hidradenitis suppurativa, where it showed rapid and durable skin clearance compared with placebo.
Mechanism of Action
Sonelokimab consists of three single‑domain camelid antibody fragments: one that neutralises IL‑17A, a second that neutralises IL‑17F, and a third that binds albumin to extend circulating half‑life. By blocking both IL‑17A and IL‑17F, it suppresses the downstream inflammatory cascade that drives keratinocyte proliferation and neutrophil recruitment in psoriatic skin and related inflammatory disorders.
What the Research Shows
A multicentre, randomised, placebo‑controlled phase 2b trial enrolled 313 adults with moderate‑to‑severe plaque psoriasis. At week 12, clear or almost clear skin (IGA 0/1) was achieved in 48% of the 30 mg group, 85% of the 60 mg group, and 77–88% of the 120 mg groups, versus 0% on placebo (p < 0.0001). Safety was comparable to the active control secukinumab, with mostly mild‑moderate nasopharyngitis, pruritus and upper‑respiratory infections; Candida infections were slightly more frequent with sonelokimab. Subsequent network meta‑analyses (2025) ranked sonelokimab among the most effective anti‑IL‑17 agents for achieving PASI 90 in psoriasis and for improving HiSCR‑50 responses in hidradenitis suppurativa, although these analyses rely on indirect comparisons.
Reported Benefits
In the phase 2b study, sonelokimab produced rapid skin clearance, with up to 88% of participants reaching clear or almost clear status by week 12, comparable to the approved IL‑17 blocker secukinumab. Network meta‑analyses suggest it is highly effective for PASI 90 outcomes in psoriasis and for HiSCR‑50 responses in hidradenitis suppurativa, indicating broad anti‑inflammatory potential across IL‑17‑driven diseases.
Limitations of the Evidence
Evidence is limited to a single phase 2b trial; no phase 3 or head‑to‑head comparisons with other biologics have been reported. Long‑term efficacy and safety beyond 52 weeks remain uncertain. The network meta‑analyses provide indirect comparisons and rely on heterogeneous trial data, so definitive conclusions about superiority cannot be drawn. Sonelokimab has not received regulatory approval for any indication.
Safety Considerations
Across the trial, 49.5% of participants reported at least one adverse event, most commonly mild‑moderate nasopharyngitis (13.5%), pruritus (6.7%) and upper‑respiratory infections (4.3%). One case of new‑onset Crohn's disease was observed. Candida infections appeared more frequent with sonelokimab than with secukinumab, though overall safety was judged comparable. No new safety signals emerged over 52 weeks.
How It Is Administered
Sonelokimab is administered by subcutaneous injection. In the phase 2b study, doses of 30 mg, 60 mg or 120 mg were given on various loading schedules (e.g., weeks 0, 2, 4, 8) followed by maintenance dosing every 4–8 weeks. Formulations are supplied as injectable solutions for clinical use in investigational settings.
Routes of Administration
Goals & Uses
- Severe asthmaRespiratoryModerate
- Chronic obstructive pulmonary disease (COPD)RespiratoryModerate
- Inhibition of IL-17A and IL-17F signalingImmunology / Cytokine BlockadeHigh
- Reduction of plaque psoriasis severityDermatology / Anti InflammatoryHigh
- Treatment of psoriatic arthritisRheumatologyLow
Contraindications
- Active serious infections (e.g., active tuberculosis)InfectionHigh
- Known hypersensitivity to sonelokimab or nanobody componentsAllergy / ImmunologyHigh
- Hypersensitivity to sonelokimab or any excipientAllergyHigh
- Active inflammatory bowel diseaseGastroenterologyModerate
Adverse Effects
- Hypersensitivity reactionsImmunologicUncommon
- Candidiasis (mucocutaneous)InfectionsUncommon
- Injection site reactionsLocalCommon
- NasopharyngitisInfectiousCommon
- Upper respiratory tract infectionInfectiousCommon
- Inflammatory bowel disease exacerbation or new onsetGastrointestinalRare
- Upper respiratory tract infectionsInfectious DiseaseCommon
- Injection site reactionLocalCommonRedness, swelling, itching, bruising, or pain at the injection site
Drug Interactions
- Live vaccinesHigh
- Immunosuppressants (e.g., systemic corticosteroids)Moderate
- Other immunosuppressants (e.g., methotrexate, cyclosporine)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeRelative
- Pregnant or breastfeeding womenReproductiveRelative
- Patients with latent tuberculosisInfectious DiseaseRelative
- Pediatric patients <12 yearsAgeAbsolute
Regulatory Status
- European UnionInvestigationalClinical trials ongoing; not yet authorized.
- United StatesInvestigationalIND in place; Phase 2/3 trials ongoing.
- United KingdomInvestigationalUnder MHRA review; trials in progress.
As of the knowledge cutoff, sonelokimab has not received regulatory approval in any major jurisdiction. Phase 3 trials (MATURA program) were ongoing or reporting results for plaque psoriasis. No FDA, EMA, or MHRA approval granted.
Evidence & Sources
- Journal ArticleModeratePapp KA, et al.2021-01-01T00:00:00.000000Z
- Journal ArticleModerateKim D, et al.2025-01-01T00:00:00.000000Z
- Journal ArticleHighGarg A, et al.2025-01-01T00:00:00.000000Z
- Journal ArticleHighSbidian E, et al.2025-01-01T00:00:00.000000Z
- Journal ArticleModerateSaran A, et al.2025-01-01T00:00:00.000000Z
- Journal ArticleModerateCrescioli S, et al.2025-01-01T00:00:00.000000Z
Frequently Asked Questions
What condition has sonelokimab been tested for?
The only published clinical trial to date evaluated sonelokimab in adults with moderate‑to‑severe plaque psoriasis, using a 12‑week primary endpoint of clear or almost clear skin.
How does sonelokimab differ from other IL‑17 blockers?
Unlike monoclonal antibodies that target a single IL‑17 isoform, sonelokimab is a trivalent nanobody that neutralises both IL‑17A and IL‑17F simultaneously, and includes an albumin‑binding domain to prolong its half‑life.
Is sonelokimab approved for clinical use?
No. Sonelokimab remains investigational and has not received regulatory approval for any indication as of the latest published data.
What are the most common side effects?
The trial reported nasopharyngitis, pruritus and upper‑respiratory tract infections as the most frequent mild‑to‑moderate adverse events; occasional Candida infections and a single case of Crohn’s disease were also noted.
How is the drug given?
It is delivered by subcutaneous injection, with dosing regimens ranging from 30 mg to 120 mg and maintenance intervals of every 4 to 8 weeks, depending on the study protocol.
What is Sonelokimab?
Sonelokimab (ALX‑0761, M1095) is an investigational trivalent nanobody that simultaneously binds interleukin‑17A, interleukin‑17F and human serum albumin. Delivered by subcutaneous injection, it has been evaluated in a phase 2b trial for moderate‑to‑severe plaque psoriasis and appears in network meta‑analyses of psoriasis and hidradenitis suppurativa, where it showed rapid and durable skin clearance compared with placebo.
What is Sonelokimab used for?
Sonelokimab is educationally associated with: Severe asthma, Chronic obstructive pulmonary disease (COPD), Inhibition of IL-17A and IL-17F signaling, Reduction of plaque psoriasis severity, Treatment of psoriatic arthritis. Educational only — not medical advice.
How is Sonelokimab administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Sonelokimab?
Reported adverse effects include: Hypersensitivity reactions, Candidiasis (mucocutaneous), Injection site reactions, Nasopharyngitis, Upper respiratory tract infection, Inflammatory bowel disease exacerbation or new onset, Upper respiratory tract infections, Injection site reaction. This list is not exhaustive — consult a qualified clinician.
Who should avoid Sonelokimab?
Recorded contraindications: Active serious infections (e.g., active tuberculosis), Known hypersensitivity to sonelokimab or nanobody components, Hypersensitivity to sonelokimab or any excipient, Active inflammatory bowel disease. Consult a qualified clinician before use.