Ablynx initiates Phase I for ALX-0141
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Ablynx announced that it has initiated a double-blind, randomised, placebo-controlled Phase I study with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL), in healthy postmenopausal women.
RANKL is involved in the production of osteoclasts, a type of cell responsible for the destruction of bone (bone resorption). Under normal physiological circumstances there is a delicate balance between bone formation and bone resorption, however, a disturbance in this balance can lead to excessive osteoclast activity and bone loss. An anti-RANKL Nanobody has the potential to inhibit this process and may have therapeutic application in the treatment of degenerative bone diseases, such as post-menopausal osteoporosis (PMO), rheumatoid arthritis and cancer driven bone deterioration.
The Phase I study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous injection of ALX-0141. In addition, the study will measure important bone biomarkers to provide an early indication of efficacy. Ablynx will recruit up to 42 postmenopausal women, who represent the initial target population for ALX-0141 in PMO.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: "We are delighted to advance ALX-0141 into the clinic within just 3.5 years of initiating this programme. There are now four Nanobodies in clinical trials including Pfizer's anti-TNF-alpha Nanobody which entered Phase II in September 2009 in patients with rheumatoid arthritis."
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