Ablynx announces an update on its ongoing Phase I study in 42 healthy post-menopausal women treated with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL)
GHENT, Belgium | January 10, 2011 | Ablynx [Euronext Brussels: ABLX] announces an update on its ongoing Phase I study in 42 healthy post-menopausal women treated with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL).
In September 2010, at 120 days follow-up, positive safety data were reported, as well as data on the pharmacokinetics (PK) of ALX-0141. The double-blind, placebo-controlled Phase I study was designed to assess safety, tolerability and PK of a subcutaneous injection of ALX-0141. In addition, serum levels of certain bone biomarkers were measured, to provide an early indication of efficacy. ALX-0141 was administered in 6 dose levels as a single subcutaneous injection ranging from 0.003 mg/kg to 1 mg/kg.
At the 9 month follow-up time point, statistically significant suppression of the bone biomarker CTX-1 was noted. Following a single dose of 1mg/kg, 4 out of 6 subjects (67%), in this highest dose group, showed statistically significant suppression of CTX-1 at 9 months and will be followed-up until their biomarker normalizes. As a comparison, published Phase I data for denosumab (a monoclonal antibody also targeting RANKL and developed by Amgen which some analysts predict will reach peak sales of $3 billion) also showed statistically significant suppression of another bone biomarker, serum NTX-1, for 9 months at the highest dose level of 3mg/kg.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: “The prolongation of biomarker suppression beyond the expected endpoint confirms the high biological activity of ALX-0141. We are delighted with the positive safety data and the drug’s PK/PD profile and we are assessing the importance of these results for the future development of the drug. We expect to have the final biomarker data available by the second quarter of 2011.”
About ALX-0141 and Receptor Activator of Nuclear Factor kappa B Ligand (RANKL)
Through its binding and activation of the RANK receptor, RANKL plays a critical role in the maturation, survival and activation of a type of cell responsible for the destruction of bone (osteoclasts). 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. Increased bone resorption and/or decreased bone formation are often hallmark symptoms of osteoporosis, cancer-induced bone loss or rheumatoid arthritis (RA) related bone erosion. ALX-0141 has the potential to inhibit this process and may have therapeutic application in the treatment of degenerative bone diseases, such as post-menopausal osteoporosis, rheumatoid arthritis and cancer driven bone deterioration.
ALX-0141 is a sequence optimised Nanobody that targets the 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, RA and bone metastases. ALX-0141 is currently in Phase I clinical development. ALX-0141 has potential to be developed in a range of indications including the treatment of osteoporosis, bone metastases in cancer and bone erosion associated with RA.
ALX-0141, like denosumab (Prolia®/Xgeva®), 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: Ablynx (Euronext: ABLX) is a biopharmaceutical company engaged in 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, including inflammation, thrombosis, oncology and Alzheimer’s disease. Today, the Company has over 25 projects in the pipeline and there are five Nanobodies in clinical development. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Pfizer. The Company is headquartered in Ghent, Belgium and currently employs over 250 people. More information can be found on www.ablynx.com.
SOURCE: Ablynx
Post Views: 72
Ablynx announces an update on its ongoing Phase I study in 42 healthy post-menopausal women treated with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL)
GHENT, Belgium | January 10, 2011 | Ablynx [Euronext Brussels: ABLX] announces an update on its ongoing Phase I study in 42 healthy post-menopausal women treated with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL).
In September 2010, at 120 days follow-up, positive safety data were reported, as well as data on the pharmacokinetics (PK) of ALX-0141. The double-blind, placebo-controlled Phase I study was designed to assess safety, tolerability and PK of a subcutaneous injection of ALX-0141. In addition, serum levels of certain bone biomarkers were measured, to provide an early indication of efficacy. ALX-0141 was administered in 6 dose levels as a single subcutaneous injection ranging from 0.003 mg/kg to 1 mg/kg.
At the 9 month follow-up time point, statistically significant suppression of the bone biomarker CTX-1 was noted. Following a single dose of 1mg/kg, 4 out of 6 subjects (67%), in this highest dose group, showed statistically significant suppression of CTX-1 at 9 months and will be followed-up until their biomarker normalizes. As a comparison, published Phase I data for denosumab (a monoclonal antibody also targeting RANKL and developed by Amgen which some analysts predict will reach peak sales of $3 billion) also showed statistically significant suppression of another bone biomarker, serum NTX-1, for 9 months at the highest dose level of 3mg/kg.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: “The prolongation of biomarker suppression beyond the expected endpoint confirms the high biological activity of ALX-0141. We are delighted with the positive safety data and the drug’s PK/PD profile and we are assessing the importance of these results for the future development of the drug. We expect to have the final biomarker data available by the second quarter of 2011.”
About ALX-0141 and Receptor Activator of Nuclear Factor kappa B Ligand (RANKL)
Through its binding and activation of the RANK receptor, RANKL plays a critical role in the maturation, survival and activation of a type of cell responsible for the destruction of bone (osteoclasts). 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. Increased bone resorption and/or decreased bone formation are often hallmark symptoms of osteoporosis, cancer-induced bone loss or rheumatoid arthritis (RA) related bone erosion. ALX-0141 has the potential to inhibit this process and may have therapeutic application in the treatment of degenerative bone diseases, such as post-menopausal osteoporosis, rheumatoid arthritis and cancer driven bone deterioration.
ALX-0141 is a sequence optimised Nanobody that targets the 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, RA and bone metastases. ALX-0141 is currently in Phase I clinical development. ALX-0141 has potential to be developed in a range of indications including the treatment of osteoporosis, bone metastases in cancer and bone erosion associated with RA.
ALX-0141, like denosumab (Prolia®/Xgeva®), 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: Ablynx (Euronext: ABLX) is a biopharmaceutical company engaged in 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, including inflammation, thrombosis, oncology and Alzheimer’s disease. Today, the Company has over 25 projects in the pipeline and there are five Nanobodies in clinical development. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Pfizer. The Company is headquartered in Ghent, Belgium and currently employs over 250 people. More information can be found on www.ablynx.com.
SOURCE: Ablynx
Post Views: 72
