ALX-0761/M1095 – anti-IL-17A/F to treat auto-immune disorders

  • ALX-0761/M1095 is being developed for the treatment of auto-immune disorders
  • ALX-0761/M1095 achieved pre-clinical proof-of-concept in an animal model for rheumatoid arthritis
  • ALX-0761/M1095 was exclusively licensed to Merck KGaA in June 2013
  • In January 2017, Merck KGaA reported encouraging results from a Phase Ib study in psoriasis patients with ALX-0761/M1095, via a clinical trials website (
  • In March 2017, Merck KGaA presented strong additional results from the Phase Ib study of M1095/ALX-0761 in psoriasis patients: PASI 90 achieved in 100% of patients in highest dose group; rapid and sustained clinical effect demonstrated


Psoriasis is a common, chronic, relapsing, immune-mediated systemic disease characterised by skin lesions including red, scaly patches, papules and plaques, which usually itch. The skin lesions seen in psoriasis may vary in severity from minor localised patches to complete body coverage. About 50% of patients with severe and moderate psoriasis receive only topical or no treatment at all and more than half of the patients are dissatified with current treatments. Recent research suggests that IL-17 blockers could be more efficaceous than TNFa blockers for the treatment of psoriasis (source: Nature Biotechnology, Vol 33, Jan 2015; Nature Reviews Drug Disovery, Hilary Bartlett & Ryan Million, Jan 2015).

ALX-0761/M1095 mode of action

ALX-0761/M1095 (40kD) is a trivalent, bi-specific Nanobody that blocks both IL-17A and IL-17F and that binds to human serum albumin for in vivo serum half-life extension. Th17 cells and IL-17 are associated with the pathology of many human inflammatory and autoimmune disorders like psoriasis, rheumatoid arthritis (RA) and multiple sclerosis.

Related presentations, abstracts and posters

Presentation: Results from the Phase Ib study of M1095/ALX-0761 at the annual AAD Conference, Orlando, Florida (5 March 2017), demonstrate that all patients in the highest dose group achieved 90% skin clearance (PASI 90).

Poster: Pre-clinical proof-of-concept of ALX-0761, a Nanobody neutralising both IL-17A and IL-17F in a cynomolgus monkey collagen induced arthritis model. (Poster presented at the Annual Meeting of the American College of Rheumatology (ACR), 26 to 30 October 2013, San Diego, California).

< back