Vobarilizumab (ALX-0061) – anti-IL-6R Nanobody to treat auto-immune disorders
- Vobarilizumab is being developed for the treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE)
- Phase IIb monotherapy study (head-to-head versus tocilizumab) in 251 RA patients succesfully completed in July 2016; demonstrating that vobarilizumab is much more efficaceous as compared to tocilizumab with up to 60% more patients in clinical remission at week 12 (DAS28 ESR < 2.6); vobarilizumab had also a favourable safety profile
- Phase IIb combination therapy (+MTX) study in 345 RA successfully completed in August 2016 with up to 52% of patients in clinical remission at week 24 (DAS28 ESR < 2.6); favourable safety profile confirmed
- 94% of eligible patients from both Phase IIb RA studies rolled-over into the 2 year open-label extension study of vobarilizumab; results expected in 2018
- Phase II study in 300 SLE patients on-going; results expected in 2018
Rheumatoid arthritis (RA)
RA is characterised by chronic and progressive joint inflammation that typically results in permanent, debilitating tissue damage, which is further compounded by joint deformation. The condition is associated with lower quality of life, premature death, disability, and unemployment. It is estimated that up to 1 percent of the adult population worldwide suffer from RA.
Systemic lupus erythematosus (SLE)
SLE is a complex, multi-organ, autoimmune disorder characterised by the production of pathogenic autoantibodies and tissue deposition of immune complexes, which result in widespread tissue damage. Although the aetiology of SLE is not fully understood, multiple genetic, environmental, and hormonal factors have been implicated in its development. The disease displays a broad variety of symptoms and highly variable clinical features, including systemic, cutaneous, renal, musculoskeletal, and haematological manifestations. Approximately 5 million people worldwide suffer from a form of lupus and 90 percent of people diagnosed are women.
Vobarilizumab mode of action
Vobarilizumab targets the interleukin 6 pathway via its IL-6 receptor (IL-6R). IL-6 is a pro-inflammatory cytokine that plays a role in T-cell activation, production of acute phase proteins in response to inflammation, induction of immunoglobulin production, and stimulation of osteoclast differentiation and activation. Vobarilizumab (26kD) has a very strong affinity for the soluble IL-6R and contains an anti-IL-6R Nanobody linked to an anti-human serum albumin (HSA) Nanobody, thereby increasing the in vivo serum half-life.
Related presentations, abstracts and posters
Poster presentation "Results of a Phase IIb Study ofVobarilizumab, an Anti-Interleukin 6 Receptor Nanobody®, in Patients with Moderate-to-Severe Rheumatoid Arthritis despite Treatment with Methotrexate", presented at the Annual Scientific Meeting of the Canadian Rheumatology Association on 9 February 2017
Poster presentation "Results of a Subgroup Analysis by Access to Biologics in a Phase IIb Study of Vobarilizumab in Patients with Moderate-to-Severe Rheumatoid Arthritis despite Treatment with Methotrexate", presented at the Annual Scientific Meeting of the Canadian Rheumatology Association on 9 February 2017
Webcast presentation 20 October 2016 - vobarilizumab, a novel best-in-class anti-IL-6R drug candidate for the treatment of rheumatoid arthitis
Webcast presentation 9 August 2016 - compelling topline results from the Phase IIb combination therapy study of vobarilizumab in patients with moderate to severe RA despite MTX therapy
Webcast presentation 7 July 2016 - positive topline results from the Phase IIb monotherapy study of vobarilizumab in patients with moderate to severe RA
Poster presentation at the 2014 American College of Rheumatology Annual Meeting 14-19 November 2014 - Impact of Clinical Remission on Physical Function in Patients with Rheumatoid Arthritis Treated with ALX-0061: Post-hoc Analysis of Phase I/II Data
Poster #1473: ALX-0061, an anti-IL-6R Nanobody for use in rheumatoid arthritis, demonstrates a different in vitro profile as compared to tocilizumab
2014 Annual European Congress of Rheumatology (EULAR) – 11-14 June 2014 Abstract + poster presentation: "Impact of Clinical Remission on Physical Function in Patients with Rheumatoid Arthritis Treated with ALX-0061: Post-hoc Analysis of Phase I/II Data"