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

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

Join For Free

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 3,300+ scientific posters on ePosters
  • More Than 4,900+ 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 TechnologyNetworks.com 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

Alizé Pharma II Acquired by Jazz Pharmaceuticals
The deal is valued at up to €18 million and did not involve transfer of any employees.
Wednesday, May 11, 2016
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
Shedding Light on HIV Vaccine Design
Broadly speaking - Mathematical modelling of host-pathogen coevolution sheds light on HIV vaccine design.
AACC 2016 Sees Clinical Chemistry Labs Drive Precision Medicine Offerings
Biomarker assays to enable precision medicine and risk assessment, mass spec-based tests designed for use in clinical labs large and small, and liquid biopsy technology captured the spotlight at the AACC annual meeting.
Automated Patch Clamping Trends
Learn more about current practices, preferences and metrics in ion channel drug screening using APC technology.
Lab-on-a-Stick: Miniaturised Clinical Testing For Fast Detection Of Antibiotic Resistance
A portable power-free test for the rapid detection of bacterial resistance to antibiotics has been developed by academics at Loughborough University and the University of Reading.
Genetic Ancestry of Cultivated Strawberry Unravelled
UNH scientists constructed a linkage map of the seven chromosomes of the diploid Fragaria iinumae, which allows them to fill in a piece of the genetic puzzle about the eight sets of chromosomes of the cultivated strawberry.
Progress In Vaccination Against Vespid Venom
Researchers at the Helmholtz Zentrum München and the Technical University Munich have presented a method which facilitates a personalised procedure for wasp allergy sufferers.
New Drug Target for Inflammatory Disorders
Penn study finds enigmatic molecules maintain equilibrium between fighting infection and inflammatory havoc.
Breast Cancer Cells Found To Switch Molecular Characteristics
Spontaneous interconversion between HER2-positive and HER2-negative states could contribute to progression, treatment resistance in breast cancer.
Mechanisms of Calcium Blockers
Researchers describe how the fundamental mode of action of two distinct chemical classes of calcium channel blockers differs.
Some Breast Cancer Patients With Low Genetic Risk Could Skip Chemotherapy
Genetic test can help predict survival and guide treatment options.
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!