Alizé Pharma SAS, an Alizé Pharma group company specialized in the development of biopharmaceuticals to treat metabolic disorders and rare diseases, will present the results from two Phase I clinical trials with its unacylated ghrelin analog AZP-531 during the 75th Scientific Sessions of the American Diabetes Association (ADA) in Boston on June 5-9, 2015.
Detailed data will be presented from the two Phase I trials conducted in 76 healthy volunteers and overweight or obese subjects. Top-line data released end of 2014 (1) indicated a good safety profile, a pharmacokinetic profile consistent with once-a-day administration and positive effects on glucose control and on body weight of obese subjects.
- Poster presentation 1097-P on Saturday, June 6, 11:30 am - 1:30 pm, General Poster Session: ‘Short-term safety, pharmacokinetic (PK) and pharmacodynamic (PD) of AZP-531, an Unacylated Ghrelin (UAG) analog in healthy and overweight/obese subjects’
- Presentation 1097-P will also be featured in a guided audio poster tour on Sunday, June 7, 1 pm – 2 pm, titled ‘New injectable therapies other than insulin’
“This clinical data clearly illustrates the therapeutic potential of AZP-531, combining insulin sensitization and weight reduction, therefore supporting further developments in type 2 diabetes and other metabolic indications,” said Thierry Abribat, manager of TAB Consulting, president of Alizé Pharma SAS. “Based on these positive results, we are currently conducting two new clinical trials in type 2 diabetes and in Prader-Willi syndrome. We look forward to releasing new data in the next few months.”
The ADA Scientific Sessions bring together over 14,000 participants with a global presence from 124 countries. The program features the most timely and significant advances in basic science and the prevention, diagnosis, and treatment of diabetes. The program includes five days of comprehensive, unparalleled education through symposia, oral abstract sessions, interest group discussions, meet-the-expert sessions, and special lectures and addresses.
About the AZP-531 program
The aim of the program is to develop AZP-531, a peptide analog of unacylated ghrelin, for the treatment of metabolic and cardiovascular disorders. Since 2008, Alizé Pharma has collaborated on this program with the Erasmus Medical Center in Rotterdam (The Netherlands) and the University of Turin (Italy). This research led to the identification of unacylated ghrelin as a new therapeutic class and to the design of AZP-531, a stabilized peptide analog. The unique pharmacological profile of AZP-531 differentiates it from ghrelin antagonists and all existing therapeutic classes. Preclinical and clinical data suggest that unacylated ghrelin and its analogs have the potential to address unmet medical needs in the treatment of type 2 diabetes, Prader Willi syndrome and some ischemia-related conditions, via a novel mechanism of action. Since the clinical program started in 2013, two Phase I trials have been completed in healthy volunteers and overweight/obese subjects. The results indicate that AZP-531 was well tolerated, with improved glucose control and decreased weight in obese subjects over a two-week treatment period. This program is in Phase II clinical development for the treatment of 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.