GHENT, Belgium I October 23, 2014 I Ablynx [Euronext Brussels: ABLX] today announced positive results from the Phase I bioavailability study of the subcutaneous formulation of its anti-IL-6R Nanobody(R), ALX-0061, for the treatment of inflammatory diseases, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Bioavailability after subcutaneous administration was higher than 80% and there were no significant safety or tolerability signals noted with subcutaneous administration of ALX-0061.
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 sc 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.
The Phase I study in healthy adult volunteers evaluated the bioavailability of single doses of ALX-0061, administered sc at three dose levels (50 mg, 150 mg and 300 mg dose), using two corresponding single intravenous (iv) dose levels (50 mg and 300 mg) as reference. In addition, the study assessed the pharmacodynamics, safety, tolerability and immunogenicity of single sc and iv doses of ALX-0061. A total of 70 subjects were included in the five treatment arms, with 14 subjects in each arm.
These results demonstrate that ALX-0061 exhibits a bioavailability of more than 80% when given subcutaneously to healthy subjects. Maximum mean ALX-0061 serum concentrations, following sc administration, were reached after approximately 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.
In addition, single iv and sc doses of ALX-0061 were safe and well tolerated at all doses tested in healthy volunteers. No deaths, severe adverse events or adverse events leading to discontinuation of dosing or subjects occurred. No clinically significant laboratory abnormalities, including irregularities in neutrophils and liver enzymes, were observed, for either of the administration routes.
Dr Edwin Moses, Chief Executive Officer of Ablynx, commented:
“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.”
About Ablynx
Ablynx is a clinical stage biopharmaceutical company engaged in the discovery and development of Nanobodies(R), a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has more than 30 programmes in the pipeline and six Nanobodies are at the clinical development stage. Ablynx has on-going research collaborations and significant partnerships with major pharmaceutical companies including AbbVie, Boehringer Ingelheim, Merck & Co, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
SOURCE: Ablynx
Post Views: 48
GHENT, Belgium I October 23, 2014 I Ablynx [Euronext Brussels: ABLX] today announced positive results from the Phase I bioavailability study of the subcutaneous formulation of its anti-IL-6R Nanobody(R), ALX-0061, for the treatment of inflammatory diseases, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Bioavailability after subcutaneous administration was higher than 80% and there were no significant safety or tolerability signals noted with subcutaneous administration of ALX-0061.
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 sc 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.
The Phase I study in healthy adult volunteers evaluated the bioavailability of single doses of ALX-0061, administered sc at three dose levels (50 mg, 150 mg and 300 mg dose), using two corresponding single intravenous (iv) dose levels (50 mg and 300 mg) as reference. In addition, the study assessed the pharmacodynamics, safety, tolerability and immunogenicity of single sc and iv doses of ALX-0061. A total of 70 subjects were included in the five treatment arms, with 14 subjects in each arm.
These results demonstrate that ALX-0061 exhibits a bioavailability of more than 80% when given subcutaneously to healthy subjects. Maximum mean ALX-0061 serum concentrations, following sc administration, were reached after approximately 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.
In addition, single iv and sc doses of ALX-0061 were safe and well tolerated at all doses tested in healthy volunteers. No deaths, severe adverse events or adverse events leading to discontinuation of dosing or subjects occurred. No clinically significant laboratory abnormalities, including irregularities in neutrophils and liver enzymes, were observed, for either of the administration routes.
Dr Edwin Moses, Chief Executive Officer of Ablynx, commented:
“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.”
About Ablynx
Ablynx is a clinical stage biopharmaceutical company engaged in the discovery and development of Nanobodies(R), a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has more than 30 programmes in the pipeline and six Nanobodies are at the clinical development stage. Ablynx has on-going research collaborations and significant partnerships with major pharmaceutical companies including AbbVie, Boehringer Ingelheim, Merck & Co, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
SOURCE: Ablynx
Post Views: 48
