Sonelokimab

Summary

Sonelokimab (M1095) is an investigational trivalent nanobody developed by Merck KGaA targeting IL-17A, IL-17F, and the IL-17A/F heterodimer. It has demonstrated promising efficacy and safety in Phase 2/3 clinical trials for moderate-to-severe plaque psoriasis, with potential advantages over monovalent IL-17 inhibitors due to its broader neutralization of IL-17 isoforms. It is administered subcutaneously.

Mechanism of Action

Sonelokimab is a trivalent nanobody that neutralizes both IL-17A and IL-17F, as well as the IL-17A/F heterodimer, by binding to these cytokines and preventing their interaction with the IL-17 receptor complex, thereby inhibiting downstream pro-inflammatory signaling involved in psoriasis and other immune-mediated diseases.

Routes of Administration

Goals & Uses

• 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
• Active inflammatory bowel diseaseGastroenterologyModerate

Adverse Effects

• Candidiasis (mucocutaneous)InfectionsUncommon
• Injection site reactionsLocalCommon
• NasopharyngitisInfectiousCommon
• Inflammatory bowel disease exacerbation or new onsetGastrointestinalRare
• Upper respiratory tract infectionsInfectious DiseaseCommon

Drug Interactions

• Live vaccinesHigh
• Other immunosuppressants (e.g., methotrexate, cyclosporine)Moderate

Population Constraints

• PregnancyReproductive SafetyRelative
• Pediatric patientsAgeRelative
• Patients with latent tuberculosisInfectious DiseaseRelative

Regulatory Status

• European UnionInvestigationalNot approved by EMA as of knowledge cutoff; clinical development ongoing.
• United StatesInvestigationalNot approved by FDA as of knowledge cutoff; Phase 3 trials ongoing.
• United KingdomInvestigationalNot approved by MHRA as of knowledge cutoff.

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

No sources recorded yet.