Ablynx announced that it has initiated a double-blind, randomised, placebo-controlled Phase I study with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL), in healthy postmenopausal women
GHENT, Belgium | December 14, 2009 | Ablynx [Euronext Brussels: ABLX] announced today that it has initiated a double-blind, randomised, placebo-controlled Phase I study with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL), in healthy postmenopausal women.
RANKL is involved in the production of osteoclasts, a type of cell responsible for the destruction of bone (bone resorption). Under normal physiological circumstances there is a delicate balance between bone formation and bone resorption, however, a disturbance in this balance can lead to excessive osteoclast activity and bone loss. An anti-RANKL Nanobody has the potential to inhibit this process and may have therapeutic application in the treatment of degenerative bone diseases, such as post-menopausal osteoporosis (PMO), rheumatoid arthritis and cancer driven bone deterioration.
The Phase I study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous injection of ALX-0141. In addition, the study will measure important bone biomarkers to provide an early indication of efficacy. Ablynx will recruit up to 42 postmenopausal women, who represent the initial target population for ALX-0141 in PMO.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: “We are delighted to advance ALX-0141 into the clinic within just 3.5 years of initiating this programme. There are now four Nanobodies in clinical trials including Pfizer’s anti-TNF-alpha Nanobody which entered Phase II in September 2009 in patients with rheumatoid arthritis.”
About ALX-0141
ALX-0141 is a sequence optimised Nanobody that targets the Receptor Activator of Nuclear Factor kappa B Ligand (RANKL). RANKL, via interaction with its cognate receptor RANK, is the central regulator of bone resorption and it activates cells involved in bone resorption. Overproduction of RANKL is implicated in a variety of degenerative bone diseases, such as osteoporosis, rheumatoid arthritis and bone metastases. ALX-0141 is currently in Phase I clinical development. Ablynx aims to develop ALX-0141 for a range of indications including the treatment of osteoporosis. Other indications include bone metastases in cancer and bone erosion associated with RA.
ALX-0141, like denosumab (Prolia®), has a novel mechanism of action that differentiates it from other anti-resorptive agents as it intervenes in bone erosion at the level of osteoclast differentiation, activation, and survival. ALX-0141 inhibits bone resorption by targeting and binding to RANKL and thereby preventing RANKL from binding to receptors on the surface of osteoclasts.
About Ablynx [Euronext Brussels: ABLX] – http://www.ablynx.com
Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company currently has over 230 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007.
Ablynx is developing a portfolio of Nanobody-based therapeutics in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Nanobodies have been generated against more than 150 different disease targets. Efficacy data have been obtained in over 26 in vivo models for Nanobodies against a range of different targets.
Ablynx has an extensive patent position in the field of Nanobodies for healthcare applications. It has exclusive and worldwide rights to more than 50 families of granted patents and pending patent applications, including the Hamers patents covering the basic structure, composition, preparation and uses of Nanobodies.
Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Pfizer (previously Wyeth Pharmaceuticals). Ablynx is building a diverse and broad portfolio of therapeutic Nanobodies through these collaborations as well as through its own internal discovery programmes.
The Company’s lead programme, ALX-0081, an intravenously administered novel anti-thrombotic has entered Phase II in patients undergoing percutaneous coronary intervention (PCI). ALX-0681, a subcutaneous formulation of the novel anti-thrombotic Nanobodies that also selectively targets von Willebrand factor (vWF), has concluded Phase I. In addition, Ablynx’s partner Pfizer initiated in September 2009 a Phase II study with an anti-TNF-alpha Nanobody. Ablynx has progressed ALX-0141, an anti-RANKL Nanobody for bone disorders into Phase I study and ALX-0061, an anti-IL6R Nanobody, is in preclinical development for the treatment of autoimmune and inflammatory diseases.
SOURCE: Ablynx NV.
Post Views: 88
Ablynx announced that it has initiated a double-blind, randomised, placebo-controlled Phase I study with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL), in healthy postmenopausal women
GHENT, Belgium | December 14, 2009 | Ablynx [Euronext Brussels: ABLX] announced today that it has initiated a double-blind, randomised, placebo-controlled Phase I study with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL), in healthy postmenopausal women.
RANKL is involved in the production of osteoclasts, a type of cell responsible for the destruction of bone (bone resorption). Under normal physiological circumstances there is a delicate balance between bone formation and bone resorption, however, a disturbance in this balance can lead to excessive osteoclast activity and bone loss. An anti-RANKL Nanobody has the potential to inhibit this process and may have therapeutic application in the treatment of degenerative bone diseases, such as post-menopausal osteoporosis (PMO), rheumatoid arthritis and cancer driven bone deterioration.
The Phase I study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous injection of ALX-0141. In addition, the study will measure important bone biomarkers to provide an early indication of efficacy. Ablynx will recruit up to 42 postmenopausal women, who represent the initial target population for ALX-0141 in PMO.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: “We are delighted to advance ALX-0141 into the clinic within just 3.5 years of initiating this programme. There are now four Nanobodies in clinical trials including Pfizer’s anti-TNF-alpha Nanobody which entered Phase II in September 2009 in patients with rheumatoid arthritis.”
About ALX-0141
ALX-0141 is a sequence optimised Nanobody that targets the Receptor Activator of Nuclear Factor kappa B Ligand (RANKL). RANKL, via interaction with its cognate receptor RANK, is the central regulator of bone resorption and it activates cells involved in bone resorption. Overproduction of RANKL is implicated in a variety of degenerative bone diseases, such as osteoporosis, rheumatoid arthritis and bone metastases. ALX-0141 is currently in Phase I clinical development. Ablynx aims to develop ALX-0141 for a range of indications including the treatment of osteoporosis. Other indications include bone metastases in cancer and bone erosion associated with RA.
ALX-0141, like denosumab (Prolia®), has a novel mechanism of action that differentiates it from other anti-resorptive agents as it intervenes in bone erosion at the level of osteoclast differentiation, activation, and survival. ALX-0141 inhibits bone resorption by targeting and binding to RANKL and thereby preventing RANKL from binding to receptors on the surface of osteoclasts.
About Ablynx [Euronext Brussels: ABLX] – http://www.ablynx.com
Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company currently has over 230 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007.
Ablynx is developing a portfolio of Nanobody-based therapeutics in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Nanobodies have been generated against more than 150 different disease targets. Efficacy data have been obtained in over 26 in vivo models for Nanobodies against a range of different targets.
Ablynx has an extensive patent position in the field of Nanobodies for healthcare applications. It has exclusive and worldwide rights to more than 50 families of granted patents and pending patent applications, including the Hamers patents covering the basic structure, composition, preparation and uses of Nanobodies.
Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Pfizer (previously Wyeth Pharmaceuticals). Ablynx is building a diverse and broad portfolio of therapeutic Nanobodies through these collaborations as well as through its own internal discovery programmes.
The Company’s lead programme, ALX-0081, an intravenously administered novel anti-thrombotic has entered Phase II in patients undergoing percutaneous coronary intervention (PCI). ALX-0681, a subcutaneous formulation of the novel anti-thrombotic Nanobodies that also selectively targets von Willebrand factor (vWF), has concluded Phase I. In addition, Ablynx’s partner Pfizer initiated in September 2009 a Phase II study with an anti-TNF-alpha Nanobody. Ablynx has progressed ALX-0141, an anti-RANKL Nanobody for bone disorders into Phase I study and ALX-0061, an anti-IL6R Nanobody, is in preclinical development for the treatment of autoimmune and inflammatory diseases.
SOURCE: Ablynx NV.
Post Views: 88
