Alize Pharma, a company specialized in the development of drugs for the treatment of metabolic diseases and rare diseases, announces today the launch of the first Phase I clinical trial for AZP-531, its unacylated ghrelin analog, in type 2 diabetes.
The Medicines and Healthcare Regulatory Agency (MHRA), the body that regulates drugs and healthcare products in the UK, has authorized this trial that will be conducted as a combined Phase Ia and Phase Ib protocol.
The clinical trial is set to last approximately 18 months. The objectives will be to assess the safety, determine the pharmacokinetic profile of AZP-531 and to provide preliminary data on AZP-531 metabolic effects, particularly on glycemia. This double-blind, placebo-controlled trial will be conducted in three parts: a single ascending dose study in healthy volunteers, a 14-day multiple ascending dose study in overweight or obese subjects and a 14-day multiple ascending dose study in type 2 diabetic patients. Up to 112 patients and healthy volunteers will be enrolled in the trial.
“We are very pleased to have reached this development milestone on AZP-531. It is the first unacylated ghrelin analog to enter clinical stage, a program based on an in-depth knowledge of the biology of ghrelin and of its role in the metabolism and metabolic disorders,” said Thierry Abribat, president of Alize Pharma. “The results of this first clinical trial will help us to assess the potential of AZP-531 for the treatment of type 2 diabetes. They will also allow initiation of clinical development in other metabolic indications, such as the Prader Willi syndrome and some ischemia-related cardiovascular indications.”
The launch of this clinical program follows five years of collaborative research between Alize Pharma and its academic partners at the Erasmus Medical Center in Rotterdam, in the Netherlands, and the University of Turin, in Italy. This research has led to the identification of unacylated ghrelin as a new therapeutic class and to the design of AZP-531. The unique pharmacological profile of AZP-531 differentiates it from ghrelin antagonists and all existing therapeutic classes. Available preclinical and clinical data suggest that UAG and its analogs improve glycemic control and insulin sensitivity, reduce fat deposition and have a positive effect on vascular remodeling and on recovery following ischemia, through a mechanism involving protection against oxidative stress.
“Following Asparec(R), AZP-531 is the second program that we are entering at the clinical stage” said Thierry Abribat. “This emphasizes the expertise in translational medicine of the Alize Pharma team, its capacity to bring innovation to the clinic and thus create value for its shareholders.”
About type 2 diabetes
Type 2 diabetes is a disease characterized by hyperglycemia, i.e. 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 to rise worldwide from 366 million in 2011 to 552 million by 2030 and the global market for antidiabetic drugs is set to increase from USD 23.7 billion in 2011 to USD 45.1 billion in 2020, representing an average annual growth of 7.4 per cent. 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 for developing innovative drugs that are based on new mechanisms of action and 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. Alize Pharma started the program five years ago in close collaboration 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, the Prader Willi syndrome and some ischemia-related conditions, through a novel mechanism of action that includes: improved glycemic control; improved insulin sensitivity; a trophic effect on beta cells; a reduction in fat deposition and a positive effect on vascular remodeling and on recovery following ischemia by protection against oxidative stress. Alize Pharma owns a portfolio of 35 pending and granted patents protecting UAG analogs and their therapeutic applications.