Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 962 |
| INN | Sonelokimab |
| Status | Clinical |
| Drug code(s) | M1095, MSB0010841, ALX-0761 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Multispecific, Trispecific |
| Format, general category | Fragment |
| Format details | sdAb, VHH-VHH'-VHH |
| Isotype (Fc) | None |
| Light chain isotype | None |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Camelid-derived |
| Target(s) | IL-17A, IL-17F, Albumin |
| Indications of clinical studies | Psoriatic arthritis, Hidradenitis suppurativa, psoriasis; Phase 1 in healthy volunteers |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 15, 2013 |
| Start of Phase 2 | July 31, 2018 |
| Start of Phase 3 | May 15, 2024 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Merck Serono |
| Licensee/Partner | MoonLake Immunotherapeutics AG, Bond Avillion 2 Development LP |
| Comments about company or candidate | Phase 3 studies NCT06641076, NCT06641089 in Psoriatic arthritis started in October 2024. Aug 2024: VELA is the first Phase 3 program in HS to use the higher clinical response (HiSCR75); topline primary endpoint readout (week 16) expected as of mid-2025 May 16, 2024: MoonLake Immunotherapeutics announced that the first patients have been screened at a U.S. trial site in its global Phase 3 clinical program, VELA, evaluating sonelokimab, an investigational Nanobody designed to treat inflammatory disease, in patients with moderate-to-severe hidradenitis suppurativa. NCT06411899 and NCT06411379 Phase 3 studies in Hidradenitis Suppurativa due to start in May 2024. Feb 2024: The Phase 3 sonelokimab program, named VELA, is expected to enroll 800 patients and in combination with the data from Phase 2 MIRA trial will support both a Biologics License Application (BLA) and E.U. Marketing Authorization Application. The readout of the primary endpoint is anticipated in mid-2025. NCT05640245 Phase 2 in Psoriatic arthritis started in Dec 2022 active not recruiting as of last update in Aug 2023. March 24, 2022 MoonLake Immunotherapeutics AG announced that it is proceeding with a global Phase 2 clinical study to evaluate sonelokimab in patients with moderate-to-severe hidradenitis suppurativa. May 4, 2021: MoonLake Immunotherapeutics AG announced that it has in-licensed the Tri-specific Nanobody® Sonelokimab (M1095/ALX 0761) from Merck KGaA, Darmstadt, Germany. NCT03384745 Phase 2 study in psoriasis started in July 2018 still recruiting as of Aug 2019. Jan 2018: Ablynx acquired by Sanofi. March 2017: Merck KGaA is partnering Phase II and Phase III development of its therapeutic anti-interleukin-17 (IL-17) A/F Nanobody® (M1095; ALX-0761) for treating plaque psoriasis, with Avillion, a U.K.-based firm focused on financing and co-developing late-stage drug candidates. Listed in EMD Serono pipeline dated July 2017. Clinical development done by Merck Serono. NCT02156466 Phase 1 study completed in Sep 2015 |
| Full address of company | Frankfurter Strasse 250, Darmstadt, 64293, Germany Europe Germany https://www.merckgroup.com/en/company.html |
Trivalent, half-life extended nanobody; 3 nanobodies head-to-tail, anti-IL17F-anti-HSA- anti-IL17A
| Anticipated events | BLA possible in 2025, but may be more likely in 2026 |
| Factor(s) contributing to discontinuation | None |