Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] announces that it will present additional data from the two Phase IIb studies in rheumatoid arthritis (RA) with its anti-IL-6R Nanobody®, vobarilizumab, at the annual European Congress of Rheumatology (EULAR), being held from 14-17 June 2017 in Madrid (Spain).
The impact of treatment with vobarilizumab on remission and maintenance of efficacy in patients with moderate-to-severe RA despite treatment with methotrexate will be presented during an oral session (OP0098) on Thursday 15 June 2017 at 10.15 a.m. Central European Time. The efficacy and safety results of several dose regimens of vobarilizumab monotherapy in patients with moderate-to-severe RA will be presented in a poster (FRI0239) on Friday 16 June 2017.
The presentation and poster will be available on the Company's website, under the news & events section, shortly after the conference.
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) is an anti-IL-6R Nanobody linked to an anti-human serum albumin (HSA) Nanobody (to increase the in vivo half-life of the molecule). Twenty-four-week data from a Phase I/IIa proof-of-concept study of ALX-0061 (vobarilizumab) in combination with methotrexate were published in February 2013, followed by the signing of a global exclusive option licensing deal with AbbVie in September 2013 for the development and commercialisation of vobarilizumab in RA and systemic lupus erythematosus (SLE).
In July 2016, Ablynx announced encouraging topline results from a 12-week Phase IIb study of vobarilizumab as a monotherapy in patients with moderate-to-severe RA which demonstrated that vobarilizumab was effective and resulted in ACR20, ACR50 and ACR70 scores of up to 81%, 49% and 24% respectively at Week 12. Moreover, vobarilizumab induced clinical remission (based on DAS28CRP <2.6) in up to 41% of patients, as compared to 27% for tocilizumab-treated patients, and it had a favourable safety profile at all administered doses.
In August 2016, Ablynx reported promising results from a 24-week Phase IIb study of vobarilizumab administered as a combination therapy with methotrexate (MTX) in patients with moderate-to-severe RA. ACR20, ACR50 and ACR70 scores at Week 24 were high and vobarilizumab had a rapid and strong impact on disease activity with up to 49% of vobarilizumab-treated patients achieving clinical remission (based on DAS28CRP <2.6) at Week 24.
Collectively the effects on clinically relevant efficacy endpoints, such as ACR70 and DAS28 remission, confirm its potential to be a best-in-class drug candidate in RA. Importantly, the collective results also confirmed the favourable safety profile of vobarilizumab in a larger patient population and the potential for convenient monthly administration.
An open-label extension study in RA patients is currently ongoing (94% roll-over rate) as well as a Phase II study in patients with SLE. The results from both of these studies are expected in 2018.
Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than 45 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.