Ablynx has 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 (50mg, 150mg or 300mg dose) or iv infusion (50mg or 300mg 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."
