Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

Alize Pharma Launches the First Phase I Clinical Trial for AZP-531

Published: Monday, July 15, 2013
Last Updated: Monday, July 15, 2013
Bookmark and Share
The Medicine and Healthcare Regulatory Authority (MHRA) has granted authorization to conduct a trial in the UK on AZP-531 in healthy volunteers, obese subjects and diabetic patients.

Alize Pharma has announced 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.

Abribat continued, “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®, 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.”

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,600+ scientific posters on ePosters
  • More Than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Alize Pharma Raises EUR 5 Million (USD 6.6 Million)
The proceeds will finance the clinical development program of AZP-531 (an unacylated ghrelin analog) in Prader-Willi syndrome and type 2 diabetes.
Wednesday, September 10, 2014
Alize Pharma Launches the PREMAG Research Program
This EUR four million collaborative project is aimed at extending the therapeutic potential of AZP-531, Alize Pharma’s unacylated ghrelin analog, to cardioprotection and cachexia.
Friday, January 04, 2013
Alize Pharma Closes EUR 3.3 Million Funding Round
The funds will enable the company to launch clinical development of its UAG (UnAcylated Ghrelin) analog for the treatment of the Prader Willi syndrome and type II diabetes in 2013.
Tuesday, June 05, 2012
Scientific News
Researchers Develop Classification Model for Cancers Caused by KRAS
Most frequently mutated cancer gene help oncologists choose more effective cancer therapies.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Chromosomal Chaos
Penn study forms basis for future precision medicine approaches for Sezary syndrome
Enzyme Malfunction May be Why Binge Drinking Can Lead to Alcoholism
A new study in mice shows that restoring the synthesis of a key brain chemical tied to inhibiting addictive behavior may help prevent alcohol cravings following binge drinking.
Key to Natural Detoxifier’s Reactivity Discovered
Results have implications for health, drug design and chemical synthesis.
New Treatment for Obesity Developed
Researchers at the University of Liverpool, working with a global healthcare company, have helped develop a new treatment for obesity.
New Protein Found in Immune Cells
Immunobiologists from the University of Freiburg discover Kidins220/ARMS in B cells and demonstrate its functions.
Will Brain Palpation Soon Be Possible?
Researchers have developed non-invasive brain imaging technique which provides the same information as physical palpation.
Shaking Up the Foundations of Epigenetics
Researchers at the Centre for Genomic Regulation (CRG) and the University of Barcelona (UB) published a study that challenges some of the current beliefs about epigenetics.
Groundbreaking Computer Program Diagnoses Cancer in Two Days
Researchers have combined genetics with computer science and created a new diagnostic technology can with 85 per cent certainty identify the source of the disease and thus target treatment and, ultimately, improve the prognosis for the patient.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos