GHENT, Belgium, April 23, 2014 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX] today announced that it has started dose administration in healthy volunteers in a Phase I clinical trial as part of the evaluation of a subcutaneous formulation of its anti-IL-6R Nanobody®, ALX-0061, for the treatment of inflammatory diseases, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
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 the Phase I bioavailability study with the subcutaneous formulation (sc) of ALX-0061 and Phase II clinical development of ALX-0061 sc in RA and SLE, both of which are expected to start in 2015. Upon the achievement of pre-defined Phase II success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialisation.
The Phase I study involves a single-centre, open-label trial to evaluate the bioavailability of ALX-0061 after sc and intravenous (iv) administration in healthy volunteers. In addition, the study will assess the pharmacodynamics, safety, tolerability and immunogenicity of single sc and iv doses of ALX-0061 in healthy subjects. The trial is expected to recruit 70 subjects who will each receive a single dose of ALX-0061, either as a sc injection (50 mg, 150 mg or 300 mg dose) or iv infusion (50 mg or 300 mg dose).
Dr Edwin Moses, CEO of Ablynx, commented:
"We are pleased that our collaboration with AbbVie is progressing well. With the start of the bioavailability study, we are on track for the further development of ALX-0061 as agreed with our partner. Results of the study are anticipated by the end of 2014, with the goal to start Phase II clinical development of ALX-0061 sc in both RA and SLE patients in 2015."
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R), which plays a key role in the inflammation process in RA. ALX-0061 has been designed to become a best-in-class therapeutic. Its small size (26kD) may potentially allow ALX-0061 to penetrate more effectively into tissues. The potent, monovalent interaction of the molecule with its target reduces the possibility of off-target effects. Its binding to human serum albumin prolongs the in vivo half-life of the product and can lead to improved trafficking to areas of inflammation. The Nanobody has a very strong affinity for soluble IL-6R which should ensure fast target engagement and could result in a fast onset of effect. ALX-0061 appears to benefit from the general Nanobody characteristic of having a very low immunogenic potential.
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 etiology 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 discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has approximately 30 programmes in the pipeline and seven Nanobodies in clinical development. Ablynx has on-going research collaborations and significant partnerships with major pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Merck & Co, 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: +44 (0)7771 954 193 /
+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, Amber Bielecka, Lindsey Neville
t: +44 203 709 5700
pdf version of the press release http://hugin.info/137912/R/1778767/607569.pdf