Alize Pharma has announced that it has completed a funding round of EUR 3.3 million. The funds will allow to take AZP-531, its UAG (UnAcylated Ghrelin) analog, into Phase I clinical trials.
Alize Pharma will carry out the first (Phase I) clinical trial of AZP-531 in healthy volunteers in 2013, which will be followed by Phase Ib and Phase II trials in patients with type II diabetes as well as in patients suffering from the Prader Willi syndrome.
Preclinical and clinical data suggest that UAG and its analogs have therapeutic potential in the targeted indications, by reducing acylated ghrelin blood levels, improving glycemic control and insulin sensitivity, and improving additional cardiovascular risk factors.
The company’s main shareholders participated in the funding round, namely Sham, OCTALFA, CEMA Inc. and Thierry Abribat.
Since its creation, the company has raised a total of EUR 8.3 million, has created value by reaching significant R&D milestones and has entered into its first strategic partnerships.
“We are grateful to our shareholders for their renewed confidence and support and are very enthusiastic to initiate the clinical development of our UAG analog,” said Thierry Abribat, president & CEO of Alize Pharma.
Abribat continued, “This development program is extremely important, since it will address significant unmet clinical needs in type II diabetes and the Prader Willi syndrome. In line with our business model, the results obtained from the first clinical trials will help us select a pharmaceutical partner capable of developing and commercializing the product under a licensing agreement.”
“As a historic shareholder in Alize Pharma, we are very pleased to support its development strategy,” said Gilles Alberici, president of Octalfa. “The quality of the team and the research programs are outstanding and we strongly believe in the company’s business model, as demonstrated by the success of the ASPAREC® program.”
The UAG program was launched in 2007 and resulted in the discovery of AZP-531, the first unacylated ghrelin analog. This 8-amino acid peptide is stable and its pharmacokinetic properties make it suitable for pharmaceutical development. AZP-531 will be the first unacylated ghrelin analog to enter regulatory development.
“The mechanism of action of AZP-531 may lead to improved glycemia control in type II diabetes and also to positive effects on other cardiovascular risk factors, such as obesity, dyslipidemia and vascular complications,” explained Professor AJ van der Lely, head of the clinical endocrinology department at the Erasmus Medical Center in Rotterdam (Netherlands) and scientific advisor at Alize Pharma.
Professor Lely continued, “In addition, it could be used to target clinical conditions where acylated ghrelin levels are abnormally high, such as the Prader Willi syndrome, thus opening up a new treatment option for these patients.”
Alize Pharma owns a portfolio of five families of patents comprising a total of 34 patents and patent applications for the protection of UAG, its analogs, including AZP-531, and their applications.
Professor AJ van der Lely and his team will present new clinical data on the effects of unacylated ghrelin in diabetic patients at the upcoming annual meeting of the Endocrine Society (ENDO 2012) that will be held in Houston from June 23 to 26, 2012.