23 October 2014 - 23 October 2014 - Belgian pharma company Ablynx (EBR:ABLX) unveiled Thursday encouraging results from a Phase I bioavailability trial of the 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).

The Phase I trial in healthy adult participants assessed the bioavailability of single doses of ALX-0061, subcutaneously administered at three dose levels (50 mg, 150 mg and 300 mg dose), using two corresponding single intravenous dose levels (50 mg and 300 mg) as reference. The trial also evaluated the pharmacodynamics, safety, tolerability and immunogenicity of single subcutaneous and intravenous doses of ALX-0061. A total of 70 participants were included in the five treatment arms of the trial, with 14 participants in each arm.

The trial's results show that ALX-0061 demonstrates a bioavailability of over 80% when given subcutaneously to healthy participants. Maximum mean ALX-0061 serum concentrations, following subcutaneous administration, were reached after about one to three days post dose. Mean serum IL-6 concentrations increased following ALX-0061 administration, with a dose-related increase in the duration of the effect, similar between the different administration routes.

Furthermore, single intravenous and subcutaneous doses of ALX-0061 proved safe and well-tolerated at all doses tested in healthy trial participants. No deaths, severe side effects or side effects leading to discontinuation of dosing or participants occurred. No clinically significant laboratory abnormalities, including irregularities in neutrophils and liver enzymes, were observed, for either of the administration routes.

Ablynx and US pharmaceutical company AbbVie Inc (NYSE:ABBV) entered into a global license agreement in September 2013 to develop and commercialise ALX-0061. Under the agreement, Ablynx is responsible for the Phase I bioavailability trial with the subcutaneous formulation of ALX-0061 and Phase II clinical development of subcutaneous ALX-0061 in RA and SLE. 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 of the therapy.

Dr Edwin Moses, CEO of Ablynx, said that the bioavailability of ALX-0061 following subcutaneous administration will be an important parameter to help determine the dosing regimen which will be used in the next phases of the therapy's development. The company remains on track to initiate the next Phase II trials with the subcutaneous formulation in RA in early 2015 and in SLE by mid-2015, Moses added. Results from the RA studies are expected in the second half of 2016, he noted.