Ablynx announced that it will present Phase I data on its anti-RANKL Nanobody®, ALX-0141, at the Annual European Congress of Rheumatology (EULAR) in London, on 27 May.
GHENT, Belgium | May 25, 2011 | Ablynx [Euronext Brussels: ABLX] today announced that it will present Phase I data on its anti-RANKL Nanobody®, ALX-0141, at the Annual European Congress of Rheumatology (EULAR) in London, on 27 May.
Ablynx conducted a first-in-human Phase I trial in healthy post-menopausal women to assess the safety, tolerability, immunogenicity and pharmacokinetics (PK) of a single subcutaneous injection of ALX-0141. In addition, specific bone biomarkers were measured to provide an early indication of efficacy.
The results from this Phase I trial, including the one year follow-up information, indicate that ALX-0141 is well tolerated and can be administered safely over a wide range of doses. All treatment related adverse events were of mild intensity, resolved within the study period and did not result in any withdrawals. Even at the lowest dose, ALX-0141 exhibited a strong and sustained inhibitory effect on bone resorption markers. As such, these data support the advancement into a Phase II clinical trial to investigate whether the early indication of efficacy can be translated into patients. The final immunogenicity data report is expected in Q3 2011 and the Phase II clinical trial is currently expected to start by the end of 2011.
The abstract: “Safety, pharmacokinetics and efficacy of anti-RANKL Nanobody, ALX-0141, in healthy postmenopausal women” is available on the EULAR website at http://www.eular.org. (Abstract No. OP-0198; Oral Presentation on Friday, 27 May at 10.30 am GMT).
Details of the Phase I study
In December 2009, Ablynx initiated a double-blind, placebo-controlled Phase I trial for ALX-0141 in healthy post-menopausal women to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous injection of ALX-0141. A total of 42 healthy volunteers were recruited and ALX-0141 was administered via a subcutaneous injection in six dose levels, ranging from 0.003 mg/kg to 1 mg/kg. In addition, serum levels of the lead bone biomarker, CTX-1, were measured to get an early indication of the Nanobody’s efficacy. At the six month follow-up time point (September 2010), serum levels of CTX-1 stayed suppressed in 27 subjects in five of the six doses. And even at the nine month follow-up time point (January 2011), statistically significant suppression of CTX-1 was measured with the highest dose of 1 mg/kg in four out of six subjects. One year following the first administered dose, bone biomarker values for all subjects had returned to the baseline level.
About RANKL and the interaction with ALX-0141
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. Osteoporosis, cancer-related bone loss, treatmentinduced bone loss and rheumatoid arthritis are associated with an increase in the rate of bone remodelling, leading to accelerated bone loss and increased risk of fractures.
Ablynx’s Nanobody, ALX-0141, inhibits bone resorption by targeting and binding to RANKL, thereby preventing RANKL from binding to receptors on the surface of osteoclasts. ALX-0141 has the potential in treating diseases characterised by unwanted bone loss such as osteoporosis, bone erosion in rheumatoid arthritis, and cancer- or treatment-induced bone loss.
The Nanobody advantages
The bivalent format of ALX-0141, together with its small size and albumin-targeting half-life extension technology may result in a number of potential product advantages including increased potency, improved tissue distribution properties, and selective targeting of inflamed and cancerous regions. In addition, the Nanobody is very stable and can be formulated in high concentrations for subcutaneous injection (up to 140mg/ml has already been achieved) without the formation of aggregates. With its size of 41kD, the Nanobody is about 1/3rd the size of a conventional monoclonal antibody, and on a molar basis, three times more Nanobody can be administered per dose. This could result in a convenient dosing and scheduling opportunity for ALX-0141 in all relevant indications. ALX-0141 is manufactured at high titres in a microbial production system, which could result in a relatively low cost of goods compared with conventional antibodies.
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 pulmonary disease. Today, the Company has over 25 projects in the pipeline and there are six 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 280 people. More information can be found on www.ablynx.com.
SOURCE: Ablynx
Post Views: 66
Ablynx announced that it will present Phase I data on its anti-RANKL Nanobody®, ALX-0141, at the Annual European Congress of Rheumatology (EULAR) in London, on 27 May.
GHENT, Belgium | May 25, 2011 | Ablynx [Euronext Brussels: ABLX] today announced that it will present Phase I data on its anti-RANKL Nanobody®, ALX-0141, at the Annual European Congress of Rheumatology (EULAR) in London, on 27 May.
Ablynx conducted a first-in-human Phase I trial in healthy post-menopausal women to assess the safety, tolerability, immunogenicity and pharmacokinetics (PK) of a single subcutaneous injection of ALX-0141. In addition, specific bone biomarkers were measured to provide an early indication of efficacy.
The results from this Phase I trial, including the one year follow-up information, indicate that ALX-0141 is well tolerated and can be administered safely over a wide range of doses. All treatment related adverse events were of mild intensity, resolved within the study period and did not result in any withdrawals. Even at the lowest dose, ALX-0141 exhibited a strong and sustained inhibitory effect on bone resorption markers. As such, these data support the advancement into a Phase II clinical trial to investigate whether the early indication of efficacy can be translated into patients. The final immunogenicity data report is expected in Q3 2011 and the Phase II clinical trial is currently expected to start by the end of 2011.
The abstract: “Safety, pharmacokinetics and efficacy of anti-RANKL Nanobody, ALX-0141, in healthy postmenopausal women” is available on the EULAR website at http://www.eular.org. (Abstract No. OP-0198; Oral Presentation on Friday, 27 May at 10.30 am GMT).
Details of the Phase I study
In December 2009, Ablynx initiated a double-blind, placebo-controlled Phase I trial for ALX-0141 in healthy post-menopausal women to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous injection of ALX-0141. A total of 42 healthy volunteers were recruited and ALX-0141 was administered via a subcutaneous injection in six dose levels, ranging from 0.003 mg/kg to 1 mg/kg. In addition, serum levels of the lead bone biomarker, CTX-1, were measured to get an early indication of the Nanobody’s efficacy. At the six month follow-up time point (September 2010), serum levels of CTX-1 stayed suppressed in 27 subjects in five of the six doses. And even at the nine month follow-up time point (January 2011), statistically significant suppression of CTX-1 was measured with the highest dose of 1 mg/kg in four out of six subjects. One year following the first administered dose, bone biomarker values for all subjects had returned to the baseline level.
About RANKL and the interaction with ALX-0141
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. Osteoporosis, cancer-related bone loss, treatmentinduced bone loss and rheumatoid arthritis are associated with an increase in the rate of bone remodelling, leading to accelerated bone loss and increased risk of fractures.
Ablynx’s Nanobody, ALX-0141, inhibits bone resorption by targeting and binding to RANKL, thereby preventing RANKL from binding to receptors on the surface of osteoclasts. ALX-0141 has the potential in treating diseases characterised by unwanted bone loss such as osteoporosis, bone erosion in rheumatoid arthritis, and cancer- or treatment-induced bone loss.
The Nanobody advantages
The bivalent format of ALX-0141, together with its small size and albumin-targeting half-life extension technology may result in a number of potential product advantages including increased potency, improved tissue distribution properties, and selective targeting of inflamed and cancerous regions. In addition, the Nanobody is very stable and can be formulated in high concentrations for subcutaneous injection (up to 140mg/ml has already been achieved) without the formation of aggregates. With its size of 41kD, the Nanobody is about 1/3rd the size of a conventional monoclonal antibody, and on a molar basis, three times more Nanobody can be administered per dose. This could result in a convenient dosing and scheduling opportunity for ALX-0141 in all relevant indications. ALX-0141 is manufactured at high titres in a microbial production system, which could result in a relatively low cost of goods compared with conventional antibodies.
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 pulmonary disease. Today, the Company has over 25 projects in the pipeline and there are six 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 280 people. More information can be found on www.ablynx.com.
SOURCE: Ablynx
Post Views: 66
