Ablynx Initiates Phase I Study For Alx-0141

Ablynx 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.

An anti-RANKL nanobody has the potential to inhibit osteoclast 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, said the company.

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.

Edwin Moses, chairman and CEO of Ablynx, said: “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.”