Phase II study to evaluate the efficacy and safety of ALX-0061, administered subcutaneously, in patients with moderate to severe, active systemic lupus erythematosus (SLE)
GHENT, Belgium I August 4, 2015 I Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced that it has administered the first dose in the Phase II STEADY study to evaluate the efficacy and safety of its anti-IL-6R Nanobody®, ALX-0061, administered subcutaneously in adult patients with moderate to severe, active seropositive SLE, despite receiving the standard-of-care. The study also aims to identify the optimum dose and frequency of administration of ALX-0061 for the next phases of development.
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 Phase II clinical development of ALX-0061 in rheumatoid arthritis and systemic lupus erythematosus.
This Phase II study in SLE is a multi-centre, randomized, double-blind, placebo-controlled, dose-range finding study. It is expected to enrol approximately 300 subjects in the United States, Europe, South America and Asia, who will be randomly assigned to placebo or one of the four different dose groups of ALX-0061. Subjects will be followed for efficacy up to and including week 48 and for safety up to and including week 58.
The study’s primary endpoint is the percentage of subjects who achieved a response at week 24 according to the composite BICLA score (BILAG-based Combined Lupus Assessment). This is a broadly accepted, sensitive, clinically meaningful composite measure of SLE disease activity that requires disease improvement across all body systems with moderate or severe baseline activity without concurrent worsening in other body systems or increase in background medication. The secondary endpoints include the composite systemic lupus erythematosus responder index (SRI), the individual components of the composite endpoints, as well the effects of ALX-0061 on health-related quality of life, flare rate and use of corticosteroids. Other planned assessments include the determination of ALX-0061 levels, biomarkers, safety, tolerability and immunogenicity.
Dr Edwin Moses, CEO of Ablynx, commented:
“Ablynx and our partner AbbVie are committed to making ALX-0061 available for patients suffering from debilitating inflammatory diseases including rheumatoid arthritis and systemic lupus erythematosus. The efficacy and safety of this novel anti-IL-6R Nanobody is currently being evaluated in multiple Phase II studies with results from the RA studies anticipated in the second half of 2016 and SLE in 2018. If the results meet the pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent development and commercialisation.”
About ALX-0061
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R) and is being developed for the treatment of RA and SLE. IL-6 is a pro-inflammatory cytokine that plays a role in T-cell activation, production of acute phase proteins in response to inflammation, induction of immunoglobulin production, and stimulation of osteoclast differentiation and activation. ALX-0061 (26kD) has a very strong affinity for the soluble IL-6R and contains an anti-IL-6R Nanobody linked to an anti-human serum albumin (HSA) Nanobody, thereby increasing the in vivo serum half-life. Phase I/II proof-of-concept results with ALX-0061 were published in February 2013, followed by the signing of a global exclusive licensing deal with AbbVie in September 2013 for the development and commercialisation of ALX-0061.
About SLE and RA
SLE is a complex, multi-organ, autoimmune disorder characterised by the production of pathogenic autoantibodies and tissue deposition of immune complexes, which result in widespread tissue damage. Although the aetiology of SLE is not fully understood, multiple genetic, environmental, and hormonal factors have been implicated in its development. The disease displays a broad variety of symptoms and highly variable clinical features, including systemic, cutaneous, renal, musculoskeletal, and haematological manifestations. Approximately 5 million people worldwide suffer from a form of lupus and 90 percent of people diagnosed are women.
RA is characterised by chronic and progressive joint inflammation that typically results in permanent, debilitating tissue damage, which is further compounded by joint deformation. The condition is associated with lower quality of life, premature death, disability, and unemployment. It is estimated that up to 1 percent of the adult population worldwide suffer from RA.
About Ablynx
Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than 30 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Merck Serono, Novartis and Taisho Pharmaceutical. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
SOURCE: Ablynx
Post Views: 143
Phase II study to evaluate the efficacy and safety of ALX-0061, administered subcutaneously, in patients with moderate to severe, active systemic lupus erythematosus (SLE)
GHENT, Belgium I August 4, 2015 I Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced that it has administered the first dose in the Phase II STEADY study to evaluate the efficacy and safety of its anti-IL-6R Nanobody®, ALX-0061, administered subcutaneously in adult patients with moderate to severe, active seropositive SLE, despite receiving the standard-of-care. The study also aims to identify the optimum dose and frequency of administration of ALX-0061 for the next phases of development.
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 Phase II clinical development of ALX-0061 in rheumatoid arthritis and systemic lupus erythematosus.
This Phase II study in SLE is a multi-centre, randomized, double-blind, placebo-controlled, dose-range finding study. It is expected to enrol approximately 300 subjects in the United States, Europe, South America and Asia, who will be randomly assigned to placebo or one of the four different dose groups of ALX-0061. Subjects will be followed for efficacy up to and including week 48 and for safety up to and including week 58.
The study’s primary endpoint is the percentage of subjects who achieved a response at week 24 according to the composite BICLA score (BILAG-based Combined Lupus Assessment). This is a broadly accepted, sensitive, clinically meaningful composite measure of SLE disease activity that requires disease improvement across all body systems with moderate or severe baseline activity without concurrent worsening in other body systems or increase in background medication. The secondary endpoints include the composite systemic lupus erythematosus responder index (SRI), the individual components of the composite endpoints, as well the effects of ALX-0061 on health-related quality of life, flare rate and use of corticosteroids. Other planned assessments include the determination of ALX-0061 levels, biomarkers, safety, tolerability and immunogenicity.
Dr Edwin Moses, CEO of Ablynx, commented:
“Ablynx and our partner AbbVie are committed to making ALX-0061 available for patients suffering from debilitating inflammatory diseases including rheumatoid arthritis and systemic lupus erythematosus. The efficacy and safety of this novel anti-IL-6R Nanobody is currently being evaluated in multiple Phase II studies with results from the RA studies anticipated in the second half of 2016 and SLE in 2018. If the results meet the pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent development and commercialisation.”
About ALX-0061
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R) and is being developed for the treatment of RA and SLE. IL-6 is a pro-inflammatory cytokine that plays a role in T-cell activation, production of acute phase proteins in response to inflammation, induction of immunoglobulin production, and stimulation of osteoclast differentiation and activation. ALX-0061 (26kD) has a very strong affinity for the soluble IL-6R and contains an anti-IL-6R Nanobody linked to an anti-human serum albumin (HSA) Nanobody, thereby increasing the in vivo serum half-life. Phase I/II proof-of-concept results with ALX-0061 were published in February 2013, followed by the signing of a global exclusive licensing deal with AbbVie in September 2013 for the development and commercialisation of ALX-0061.
About SLE and RA
SLE is a complex, multi-organ, autoimmune disorder characterised by the production of pathogenic autoantibodies and tissue deposition of immune complexes, which result in widespread tissue damage. Although the aetiology of SLE is not fully understood, multiple genetic, environmental, and hormonal factors have been implicated in its development. The disease displays a broad variety of symptoms and highly variable clinical features, including systemic, cutaneous, renal, musculoskeletal, and haematological manifestations. Approximately 5 million people worldwide suffer from a form of lupus and 90 percent of people diagnosed are women.
RA is characterised by chronic and progressive joint inflammation that typically results in permanent, debilitating tissue damage, which is further compounded by joint deformation. The condition is associated with lower quality of life, premature death, disability, and unemployment. It is estimated that up to 1 percent of the adult population worldwide suffer from RA.
About Ablynx
Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than 30 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Merck Serono, Novartis and Taisho Pharmaceutical. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
SOURCE: Ablynx
Post Views: 143
