Phase IIb study to evaluate ALX-0061 monotherapy in adult patients with active rheumatoid arthritis (RA) who are intolerant to methotrexate, or for whom methotrexate treatment is inappropriate
GHENT, Belgium, April 7, 2015 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX; OTC market: ABYLY] today announced that it has administered the first dose in the Phase IIb study to evaluate the efficacy and safety of its anti-IL-6R Nanobody®, ALX-0061, administered subcutaneously (sc) as a monotherapy in adult patients with active RA who are intolerant to methotrexate (MTX), or for whom MTX is inappropriate. The study also aims to obtain parallel descriptive information concerning the efficacy and safety of administration of sc tocilizumab (Actemra®, RoActemra®) in the same RA population.
In September 2013, Ablynx and AbbVie entered into a global license agreement, worth up to US$840 million plus double-digit royalties, to develop and commercialise ALX-0061. As part of the agreement, Ablynx is responsible for Phase II clinical development of ALX-0061 in both RA and systemic lupus erythematosus (SLE). The first Phase IIb study with ALX-0061 in combination with MTX in patients with active RA started on 17 March 2015.
This current Phase IIb study is a multi-centre, randomised study consisting of two parallel treatment groups: a double-blind part to assess the efficacy and safety of ALX-0061 sc and an open-label part (with a blinded independent joint-assessor) with tocilizumab sc, which is not used as an active comparator but to provide parallel efficacy and safety data for sc tocilizumab in the same RA patient population.
The study is expected to enrol 228 subjects in the United States, Europe and South America, who will be randomly assigned to three different dose groups of ALX-0061 sc or one dose group of tocilizumab sc1. Administration of ALX-0061 will be performed every 2 weeks or every 4 weeks for 12 weeks. Subjects will be followed for efficacy up to week 12 and for safety until 12 weeks after last dosing. Following completion of the 12-week dosing, eligible subjects will be invited to participate in an open-label extension study.
The primary endpoint is the ACR20 response2 of ALX-0061 at week 12, a broadly accepted clinical response measure to demonstrate reduction in RA signs and symptoms. The secondary endpoints include higher level of response assessments of ALX-0061, documentation of efficacy of ALX-0061 over time, as well as the effects of ALX-0061 on the improvement in physical function and health-related quality of life. Other planned assessments include the determination of ALX-0061 levels, biomarkers, safety, tolerability and immunogenicity.
Dr Edwin Moses, CEO of Ablynx, commented:
"Ablynx and our partner AbbVie are committed to developing ALX-0061 for people living with rheumatoid arthritis. The start of this second Phase IIb study in this chronic and progressive disease is therefore another important milestone. We expect top line results from the two Phase IIb studies in RA before the end of 2016. If the results meet pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialisation."
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R) and has been developed for the treatment of RA and possibly systemic lupus erythematosus (SLE). 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. ALX-0061 (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. Phase I/II proof-of-concept results with ALX-0061 were published in February 2013, followed by the signing of a global exclusive licensing deal with AbbVie in September 2013 for the development and commercialisation of ALX-0061.
About RA and SLE
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.
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.
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 30 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Merck & Co., Inc, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
For more information, please contact
Dr Edwin Moses
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
Follow us on Twitter @AblynxABLX
Ablynx media relations Consilium Strategic Communications:
Mary-Jane Elliott, Jonathan Birt, Amber Bielecka, Lindsey Neville
t: +44 203 709 5700
1 Subjects will receive tocilizumab dosing regimen approved in their region: 1) US: 162 mg every 2 weeks (subjects weighing < 100kg) or every week (for subjects weighing more than or equal to 100 kg). 2) EU: 162 mg every week for all subjects
2 ACR (American College of Rheumatology) responses measure improvements in tender and swollen joint counts and improvements in three of five other disease-activity measures. To achieve an ACR20 the patients must show an improvement of at least 20%.
pdf format of the press release http://hugin.info/137912/R/1908942/680372.pdf