Belgium-based biopharmaceutical firm Ablynx has reported positive results from the Phase I bioavailability trial of the subcutaneous (SC) formulation of its anti-IL-6R Nanobody, ALX-0061, to treat inflammatory diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
The trial evaluated the bioavailability of single doses of ALX-0061, administered SC at three dose levels 50mg, 150mg and 300mg dose, using two corresponding single intravenous (IV) dose levels 50mg and 300mg as reference.
The trial also evaluated the pharmacodynamics, safety, tolerability and immunogenicity of single SC and IV doses of ALX-0061.
In the Phase I trial, a total of 70 subjects were enrolled in five treatment arms, with 14 subjects in each arm.
The results show that the bioavailability after subcutaneous administration was higher than 80% and there were no significant safety or tolerability signals noted with SC administration of ALX-0061.
Additionally, single IV and SC doses of ALX-0061 were seen to be safe and well tolerated at all doses tested in healthy volunteers, and there were no deaths, severe adverse events or adverse events leading to discontinuation of dosing or subjects.
Ablynx and AbbVie entered into a global license agreement in September 2013, worth about $840m plus double-digit royalties, to develop and commercialise ALX-0061.
Under that deal, Ablynx is responsible for the Phase I bioavailability trial with the SC formulation of ALX-0061 and Phase II clinical development of SC ALX-0061 in RA and SLE.
After achievement of pre-defined Phase II success criteria, AbbVie will exercise its right to in-license ALX-0061 and will be responsible for subsequent Phase III clinical development and commercialisation.
Ablynx chief executive officer Dr Edwin Moses said: "We and our partner AbbVie are pleased to show the bioavailability of ALX-0061 following subcutaneous administration, which will be an important parameter to help determine the dosing regimen that will be used in the next phases of development.
"We remain on track to start the next Phase II studies with this subcutaneous formulation in RA in early 2015 and in SLE by mid-2015, with results from the RA studies expected in the second half of 2016."
Image: An untreated severe arthritis in hand. Photo: courtesy of Doc James.
