Clinical Trials

* On October 29, 2015, Alizé Pharma announced the completion of a Phase Ib trial for AZP-531 in 36 Type 2 Diabetes (T2D) patients. This trial was the last stage in an overall Phase I program performed in 112 healthy volunteers, obese subjects and T2D patients. The T2D trial was a double-blind 14-day multiple ascending dose Phase Ib study. The aim of the trial was to assess the effect of three doses of AZP-531 versus placebo in a total of 36 uncontrolled T2D patients treated with metformin as a single agent. The study was conducted in a single London-based Phase I center where patients stayed for the full duration of the treatment period. The results showed an improvement in the metabolic status of patients in all groups, including placebo, suggesting a study effect in an uncontrolled T2D patient population. Notwithstanding this study effect, there was a better metabolic improvement with AZP-531. In particular, at the highest doses being studied (60 mcg/kg QD and 30 mcg/kg BID), HbA1c was significantly decreased with a mean decrease of -0.4% in 14 days (p(60 mcg/kg QD) with a mean decrease of -2.1 kg in 14 days (pAdministration of AZP-531 for 14 days was well tolerated across all doses. The single and multiple-dose PK parameters were comparable to those observed in healthy and obese study populations from previous AZP-531 trials.
• Pharmacokinetics: Subcutaneous administration resulted in 24-hour exposure toAZP-531, supporting a once-daily treatment regimen
• Pharmacodynamics: Data yielded highly promising and convergent signals of metabolic improvement in AZP-531 treated groups:
o Decreased glucose levels in obese subjects, especially in those with impaired glucose tolerance
o Decreased HbA1c in T2D patients
o No change in insulin levels, consistent with the insulin-sensitizing mechanism
of action
o Decreased body weight in obese subjects and T2D patients
Alize Pharla also provided an update on Phase II trial in Prader-Willi syndrome. The multi-center, randomized, double-blind trial aims to enroll up to 40 patients with Prader-Willi Syndrome (PWS) and assess the safety and efficacy of a two-week daily
administration of AZP-531 vs. placebo. Recruitment is well advanced and as of today approximately two-thirds of patients have completed the treatment and follow-up periods. The drug has been well tolerated so far. An independent Data Monitoring
Committee has reviewed the data collected from the first 20 completed patients and has not raised any safety concerns. Results from this Phase II trial are due to be available in the first half of 2016.
* On May 26, 2015, Alizé Pharma announced that the company 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 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 : ‘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’.

* On December 10, 2014, Alizé Pharma announced the completion of two Phase I clinical trials with its unacylated ghrelin analog AZP-531 in 76 healthy volunteers and overweight or obese subjects. The results to date indicate a good safety profile, a pharmacokinetic profile consistent with once-a-day administration and positive effects on glucose control and on weight. They are consistent with pharmacological data obtained in animal models and support a differentiated clinical profile for AZP-531 in metabolic indications. The clinical trials were conducted as parts of an overall program that aims to develop AZP-531 for the treatment of type 2 diabetes and Prader-Willi syndrome. The trials in healthy volunteers, in overweight/obese subjects and in type 2 diabetes patients are all parts of a combined protocol authorized by the Medicine and Healthcare Regulatory Authority (MHRA) in the UK. The first trial was a double-blind, single ascending dose Phase Ia study in healthy volunteers, investigating the effect of six doses of AZP-531 versus placebo in a total of 44 volunteers. The second trial was a double-blind 14-day multiple ascending dose Phase Ib study that aimed to assess the effect of four doses of AZP-531 versus a placebo in a total of 32 overweight or obese, otherwise healthy subjects. The main findings were as follows: Following repeated administration for 14 days AZP-531 was well tolerated at all doses tested. Once-a-day subcutaneous administration resulted in 24 hour exposure to AZP-531 at the higher doses tested. Reductions in blood glucose levels were observed in overweight and obese subjects, particularly in those with elevated post-prandial glucose levels at baseline. The effects increased over time of treatment and were associated with unchanged insulin levels, supporting an insulin-sensitizing mechanism of action. After 14 days of treatment significant reductions in body weight were observed in overweight and obese subjects, in the AZP-531 treated subjects but not in the placebo group 

Detailed results will be presented at scientific and medical conferences in 2015. Based on these positive results, Alizé Pharma SAS has initiated a new Phase Ib trial in type 2 diabetes patients. This is a multiple ascending dose, double-blind and placebo controlled study to assess the safety, pharmacokinetics and pharmacodynamic response of three doses of AZP-531 administered over 14 days. The study will be conducted in 36 uncontrolled type 2 diabetes patients treated with metformin. The results are expected in the second half of 2015.

* On July 15, 2013, Alizé Pharma, a company specialized in the development of drugs for the treatment of metabolic diseases and rare diseases, 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. The launch of this clinical program follows five years of collaborative research between Alizé 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 (UAG) as a new therapeutic class, and to the design of AZP-531. 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.