Based on these results, a Phase Ib trial has been launched in type 2 diabetes patients
LYON, France I December 10, 2014 I Alizé Pharma SAS, an Alizé Pharma group company specialized in the development of biopharmaceuticals to treat metabolic disorders and rare diseases, announces today the completion of two Phase I clinical trials with its unacylated ghrelin analog AZP-531 in 76 healthy volunteers and overweight or obese subjects.
The results to date indicate a good safety profile, a pharmacokinetic profile consistent with once-a-day administration and positive effects on glucose control and on weight. They are consistent with pharmacological data obtained in animal models and support a differentiated clinical profile for AZP-531 in metabolic indications. The clinical trials were conducted as parts of an overall program that aims to develop AZP-531 for the treatment of type 2 diabetes and Prader-Willi syndrome.
The first trial was a double-blind, single ascending dose Phase Ia study in healthy volunteers, investigating the effect of six doses of AZP-531 versus placebo in a total of 44 volunteers. The second trial was a double-blind 14-day multiple ascending dose Phase Ib study that aimed to assess the effect of four doses of AZP-531 versus a placebo in a total of 32 overweight or obese, otherwise healthy subjects.
The main findings were as follows:
Following repeated administration for 14 days AZP-531 was well tolerated at all doses tested
Once-a-day subcutaneous administration resulted in 24 hour exposure to AZP-531 at the higher doses tested
Reductions in blood glucose levels were observed in overweight and obese subjects, particularly in those with elevated post-prandial glucose levels at baseline. The effects increased over time of treatment and were associated with unchanged insulin levels, supporting an insulin-sensitizing mechanism of action
After 14 days of treatment significant reductions in body weight were observed in overweight and obese subjects, in the AZP-531 treated subjects but not in the placebo group
Detailed results will be presented at scientific and medical conferences in 2015.
Based on these positive results, Alizé Pharma SAS has initiated a new Phase Ib trial in type 2 diabetes patients. This is a multiple ascending dose, double-blind and placebo controlled study to assess the safety, pharmacokinetics and pharmacodynamic response of three doses of AZP-531 administered over 14 days. The study will be conducted in 36 uncontrolled type 2 diabetes patients treated with metformin. The results are expected in the second half of 2015.
“Our results point to a differentiated clinical profile for AZP-531, combining insulin sensitization and reduced weight. This could fulfill important medical needs in type 2 diabetes and be highly complementary to existing therapeutic classes, especially GLP-1 agonists.” said Thierry Abribat, manager of TAB Consulting, president of Alizé Pharma. “Based on these positive results, we now look forward to engaging in partnering discussions for the AZP-531 program.”
Dr Soraya Allas, medical director at Alizé Pharma said: “So far we are very pleased with the results of these first-in-man clinical trials performed in 76 healthy volunteers and obese subjects. They support the development of AZP-531 as a new therapeutic approach in metabolic indications.” She added: “Our next step will be to deliver preliminary safety and efficacy data in type 2 diabetes patients and in patients with Prader-Willi syndrome.”
The trials in healthy volunteers, in overweight/obese subjects and in type 2 diabetes patients are all parts of a combined protocol authorized by the Medicine and Healthcare Regulatory Authority (MHRA) in the UK.
About type 2 diabetes
Type 2 diabetes is a disease characterized by hyperglycemia; an excessively high level of glucose (sugar) in the blood. This disease generally occurs in adults of an advanced age and tends to affect obese or overweight people. The number of patients suffering from type 2 diabetes is constantly rising as a result of the spread of obesity and aging of the population. The International Diabetes Federation expects the number of diabetic patients worldwide to rise from 387 million in 2014 to 592 million by 2035. The global market for type 2 diabetes drugs is set to increase from $20.4 billion in 2012 to $38.8 billion in 2019, representing an average annual growth of 10.2%. Managing diabetes and its cardiovascular complications is a major public health challenge. Currently, all available drugs only delay the progress of the disease, there is no treatment that can cure diabetes and its complications. In this context, there is a major medical need to develop innovative drugs that are based on new mechanisms of action in order to target several cardiovascular risk factors.
About the UAG (UnAcylated Ghrelin) program
The aim of the UAG program is to develop AZP-531, an analog of unacylated ghrelin, the first product of a new therapeutic class for the treatment of metabolic and cardiovascular disorders. Since 2008 Alizé Pharma has collaborated on this program with the Erasmus Medical Center in Rotterdam and the University of Turin. Preclinical and clinical data suggest that unacylated ghrelin and its analogs have the therapeutic potential to address unmet medical needs in the treatment of type 2 diabetes, Prader Willi syndrome and some ischemia-related conditions. In 2014, the UAG/AZP-531 program is in Phase II clinical development for hyperphagia associated with Prader-Willi syndrome and in Phase Ib for type 2 diabetes. Alizé Pharma owns a portfolio of 37 pending and granted patents protecting UAG analogs and their therapeutic applications.
About Alizé Pharma
Alizé Pharma is a group of companies specialized in the development of innovative biopharmaceutical drugs, proteins and peptides for the treatment of metabolic diseases and rare diseases. The management is a team of drug development experts and the board of directors has a breadth of international experience. Its business strategy is to advance programs based on medical innovation to the clinical stage and establish partnerships with pharmaceutical companies to secure both short- and long-term revenue streams.
Since its creation in 2007 the group has raised €13.3 million ($16.6 million) from private and institutional investors. It has advanced two programs to the clinical phase and has also signed its first industrial partnership.
The first group entity, Alizé Pharma SAS, is working on a peptide derived from unacylated ghrelin (AZP531). This program is in Phase II clinical development for the treatment of Prader-Willi syndrome and in Phase Ib for type 2 diabetes.
The second entity, Alizé Pharma II SAS, is focusing on the development of pegcrisantaspase (ASPAREC® / JZP416), a new pegylated recombinant L-asparaginase for the treatment of acute lymphoblastic leukemia (ALL). It is partnered with Jazz Pharmaceuticals (Nasdaq: JAZZ) and is currently in Phase II/III clinical development.
Founded in 2014, Alizé Pharma III SAS has acquired exclusive worldwide rights to develop and commercialize a family of new peptides with bone anabolic properties.
SOURCE: Alize Pharma
Post Views: 60
Based on these results, a Phase Ib trial has been launched in type 2 diabetes patients
LYON, France I December 10, 2014 I Alizé Pharma SAS, an Alizé Pharma group company specialized in the development of biopharmaceuticals to treat metabolic disorders and rare diseases, announces today the completion of two Phase I clinical trials with its unacylated ghrelin analog AZP-531 in 76 healthy volunteers and overweight or obese subjects.
The results to date indicate a good safety profile, a pharmacokinetic profile consistent with once-a-day administration and positive effects on glucose control and on weight. They are consistent with pharmacological data obtained in animal models and support a differentiated clinical profile for AZP-531 in metabolic indications. The clinical trials were conducted as parts of an overall program that aims to develop AZP-531 for the treatment of type 2 diabetes and Prader-Willi syndrome.
The first trial was a double-blind, single ascending dose Phase Ia study in healthy volunteers, investigating the effect of six doses of AZP-531 versus placebo in a total of 44 volunteers. The second trial was a double-blind 14-day multiple ascending dose Phase Ib study that aimed to assess the effect of four doses of AZP-531 versus a placebo in a total of 32 overweight or obese, otherwise healthy subjects.
The main findings were as follows:
Following repeated administration for 14 days AZP-531 was well tolerated at all doses tested
Once-a-day subcutaneous administration resulted in 24 hour exposure to AZP-531 at the higher doses tested
Reductions in blood glucose levels were observed in overweight and obese subjects, particularly in those with elevated post-prandial glucose levels at baseline. The effects increased over time of treatment and were associated with unchanged insulin levels, supporting an insulin-sensitizing mechanism of action
After 14 days of treatment significant reductions in body weight were observed in overweight and obese subjects, in the AZP-531 treated subjects but not in the placebo group
Detailed results will be presented at scientific and medical conferences in 2015.
Based on these positive results, Alizé Pharma SAS has initiated a new Phase Ib trial in type 2 diabetes patients. This is a multiple ascending dose, double-blind and placebo controlled study to assess the safety, pharmacokinetics and pharmacodynamic response of three doses of AZP-531 administered over 14 days. The study will be conducted in 36 uncontrolled type 2 diabetes patients treated with metformin. The results are expected in the second half of 2015.
“Our results point to a differentiated clinical profile for AZP-531, combining insulin sensitization and reduced weight. This could fulfill important medical needs in type 2 diabetes and be highly complementary to existing therapeutic classes, especially GLP-1 agonists.” said Thierry Abribat, manager of TAB Consulting, president of Alizé Pharma. “Based on these positive results, we now look forward to engaging in partnering discussions for the AZP-531 program.”
Dr Soraya Allas, medical director at Alizé Pharma said: “So far we are very pleased with the results of these first-in-man clinical trials performed in 76 healthy volunteers and obese subjects. They support the development of AZP-531 as a new therapeutic approach in metabolic indications.” She added: “Our next step will be to deliver preliminary safety and efficacy data in type 2 diabetes patients and in patients with Prader-Willi syndrome.”
The trials in healthy volunteers, in overweight/obese subjects and in type 2 diabetes patients are all parts of a combined protocol authorized by the Medicine and Healthcare Regulatory Authority (MHRA) in the UK.
About type 2 diabetes
Type 2 diabetes is a disease characterized by hyperglycemia; an excessively high level of glucose (sugar) in the blood. This disease generally occurs in adults of an advanced age and tends to affect obese or overweight people. The number of patients suffering from type 2 diabetes is constantly rising as a result of the spread of obesity and aging of the population. The International Diabetes Federation expects the number of diabetic patients worldwide to rise from 387 million in 2014 to 592 million by 2035. The global market for type 2 diabetes drugs is set to increase from $20.4 billion in 2012 to $38.8 billion in 2019, representing an average annual growth of 10.2%. Managing diabetes and its cardiovascular complications is a major public health challenge. Currently, all available drugs only delay the progress of the disease, there is no treatment that can cure diabetes and its complications. In this context, there is a major medical need to develop innovative drugs that are based on new mechanisms of action in order to target several cardiovascular risk factors.
About the UAG (UnAcylated Ghrelin) program
The aim of the UAG program is to develop AZP-531, an analog of unacylated ghrelin, the first product of a new therapeutic class for the treatment of metabolic and cardiovascular disorders. Since 2008 Alizé Pharma has collaborated on this program with the Erasmus Medical Center in Rotterdam and the University of Turin. Preclinical and clinical data suggest that unacylated ghrelin and its analogs have the therapeutic potential to address unmet medical needs in the treatment of type 2 diabetes, Prader Willi syndrome and some ischemia-related conditions. In 2014, the UAG/AZP-531 program is in Phase II clinical development for hyperphagia associated with Prader-Willi syndrome and in Phase Ib for type 2 diabetes. Alizé Pharma owns a portfolio of 37 pending and granted patents protecting UAG analogs and their therapeutic applications.
About Alizé Pharma
Alizé Pharma is a group of companies specialized in the development of innovative biopharmaceutical drugs, proteins and peptides for the treatment of metabolic diseases and rare diseases. The management is a team of drug development experts and the board of directors has a breadth of international experience. Its business strategy is to advance programs based on medical innovation to the clinical stage and establish partnerships with pharmaceutical companies to secure both short- and long-term revenue streams.
Since its creation in 2007 the group has raised €13.3 million ($16.6 million) from private and institutional investors. It has advanced two programs to the clinical phase and has also signed its first industrial partnership.
The first group entity, Alizé Pharma SAS, is working on a peptide derived from unacylated ghrelin (AZP531). This program is in Phase II clinical development for the treatment of Prader-Willi syndrome and in Phase Ib for type 2 diabetes.
The second entity, Alizé Pharma II SAS, is focusing on the development of pegcrisantaspase (ASPAREC® / JZP416), a new pegylated recombinant L-asparaginase for the treatment of acute lymphoblastic leukemia (ALL). It is partnered with Jazz Pharmaceuticals (Nasdaq: JAZZ) and is currently in Phase II/III clinical development.
Founded in 2014, Alizé Pharma III SAS has acquired exclusive worldwide rights to develop and commercialize a family of new peptides with bone anabolic properties.
SOURCE: Alize Pharma
Post Views: 60
