The first unacylated ghrelin analog clinical trial has been authorised in the UK

Medicine company Alize Pharma has been granted permission for a UK Phase I study of AZP-531. The Medicine and Healthcare Regulatory Authority (MHRA) has given permission for the trial of the type 2 diabetes drug.

The 18-month Phase I trial will involve diabetic patients, volunteers and obese patients and will follow the combined protocols for Phase Ia and Phase Ib trials. The trial aims to assess the pharmacokinetic profile of the drug whilst also providing information on the metabolic effects of the medication. A particular focus is to be placed upon the effect that AZP-531 has on glycemia - the level of glucose in the blood.

The trial has been designed as a placebo-controlled, double-blind study with three parts. For the treatment of patients with type two diabetes and obese patients the trial will involve an increase in dosage throughout a 14-day period and healthy volunteers will be part of a single increasing dose study. The Phase I trial will involve around 112 subjects - both volunteers and patients.

The AzP-531 trial comes after five years of collaboration with the Erasmus Medical Centre in Rotterdam and Italy's University of Turin. The overall design of the drug follows on from the initial identification of a new therapeutic class - unacylated ghrelin. This has allowed for the development of a drug that does not follow the usual pharmacological profile found in existing therapeutic classes or ghrelin antagonists.

Current data on unacylated ghrelin determines that it can help to improve insulin sensitivity and glycemic control, helping to limit the concentration of glucose in the blood. It has also been found to lower fat deposition and aid in vascular remodelling.

Thierry Abribat, Alize Pharma president, said: “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.

"The results of this first clinical trial will help us to assess the potential of AZP-531 for the treatment of type two 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.”