Alize Pharma Launches the PREMAG Research Program

Published: Jan 04, 2013

Lyon, France, January 3, 2013 – Alize Pharma, a group of companies specialized in the development of drugs for the treatment of metabolic disorders and rare diseases, announces today the launch of the PREMAG collaborative research program. This program will be conducted within a consortium of partners focusing on the development of AZP-531, Alize Pharma’s unacylated ghrelin analog and biomarkers; for therapeutic applications in muscular protection and regeneration.

The PREMAG project brings together five partners from both the private and academic sectors, having complementary multidisciplinary expertise:

• Alize Pharma, leader of the project

• The team of Prof. Michel Ovize, head of the cardiology department at the Hospices Civils de Lyon and head of the cardioprotection group at the CarMeN (Cardiology, Metabolism and Nutrition) unit of Inserm, the French National Institute of Health and Medical Research, in Lyon (Inserm 1060)

• The team of Prof. Jeanne-Marie Bonnet, professor of physiology at the VetAgro Sup in Lyon (Lyon School of Veterinary Medicine)

• Ricerca Biosciences, a contract research organization located near Lyon and specialized in the preclinical safety assessment of drug candidates

• Bertin Pharma, near Paris, a company specialized in the development of analytical methods and biomarkers.

Promising preliminary results have already been obtained by Alize Pharma and independent research groups in the fields of cardioprotection and muscle regeneration. On this basis, the PREMAG project aims at extending the therapeutic potential of AZP-531, an unacylated ghrelin analog, to additional indications such as the cardiovascular complications of diabetes, cardioprotection following ischemia-reperfusion and cachexia associated with chronic diseases. This collaborative research will involve the implementation of clinically relevant experimental models and biomarkers. The results could lead to the start of clinical trials in these indications.

The PREMAG program focuses on clinical indications with high unmet medical needs. Cardiac reperfusion injury occurs after reperfusion (the restoration of blood flow) following myocardial infarction and represents approximately 40 per cent of the final size of the infarction. There is currently no treatment for reducing reperfusion injury. Cachexia is characterized by muscle loss and is typically associated with a chronic disease. It can be associated with chronic heart failure, a long-term complication of myocardial infarction. There is presently no approved treatment for this condition.

The EUR 3.9 million PREMAG project has been accredited by the Lyonbiopole and Medicen competitive clusters. It will be financed in part by grants of up to EUR 1.5 million from the French government’s Single Interministerial Fund (FUI), the Rhone-Alpes region, Greater Lyon and the European Regional Development Fund (FEDER). These grants were obtained through the 14th call for FUI R&D projects.

“We are very pleased to launch the collaborative PREMAG project with partners that are undisputed leaders in their respective fields and are grateful to the public authorities for their financial support,” said Alize Pharma’s president, Thierry Abribat. “The results will allow us to explore new indications for AZP-531, our unacylated ghrelin analog that will soon enter clinical development in type II diabetes and the Prader Willi syndrome. This project matches the ambitions we have for our product and will help to speed up its development.”

“There is a great medical need in the area of post-infarction reperfusion and cachexia,” said Prof. Michel Ovize, head of the cardiology department at the Cardiology and Pneumonology Hospital in Lyon. “There is no approved treatment at the moment for the targeted indications. The unacylated ghrelin analog approach is promising on the basis of its mechanism of action and the available results.”

About ischemia-reperfusion

Acute myocardial infarction is a common and debilitating disease, resulting in around 1.4 million hospitalizations in North America and Europe each year. The infarction size is the major determinant of mortality in these patients. Limiting the size of the infarction is of paramount importance for improving outcomes. At the moment, the most reliable means of limiting it is to reperfuse the ischemic myocardium as quickly as possible, using thrombolysis or coronary angioplasty. Although necessary, reperfusion causes irreversible myocardial damage. There is no treatment available today for preventing reperfusion lesions, which represent on average 40 per cent of the final size of an infarction. As a result, any new treatment that is shown to be effective in preventing or reducing the harmful consequences of reperfusion will make a major contribution to improving the care of patients.

About cachexia

Cachexia is characterized by muscle loss and biochemical abnormalities including inflammation, and is associated with the advanced stages of chronic diseases such as cancer, chronic heart failure (CHF), rheumatoid arthritis, sepsis, renal insufficiency and chronic obstructive pulmonary disease (COPD). In all such cases, it represents an independent risk factor of morbidity and mortality. For example, the prevalence of cachexia in patients suffering from CHF is estimated at around 500,000 in the United States. This is the second most common cause of cachexia after that associated with COPD (3.2 million patients in the United States). There is currently no approved medical treatment for cachexia associated with CHF.

About UAG (UnAcylated Ghrelin)

The aim of the UAG program is to develop AZP-531, an analog of unacylated ghrelin, the first product of a new therapeutic class for the treatment of metabolic disorders. Alize Pharma started the program five years ago in close collaboration with the Erasmus Medical Center in Rotterdam and the University of Turin. Preclinical and clinical data suggest that unacylated ghrelin and its analogs have the therapeutic potential to address unmet medical needs in the treatment of type II diabetes and the Prader Willi syndrome through a novel mechanism of action that includes: a marked decrease in the blood levels of acylated ghrelin, an orexigenic and diabetogenic hormone; improved glycemic control; improved insulin sensitivity; a trophic effect on beta cells; a reduction in fat deposition and a positive effect on vascular remodeling and on recovery following ischemia.

About Alize Pharma

Alize Pharma is a group of companies specialized in the development of innovative biopharmaceutical drugs, proteins and peptides for the treatment of metabolic diseases and rare diseases. Its management is made up of a team of drug development experts and a board of directors with broad international experience. Its business strategy is to advance programs based on medical innovation to the clinical stage and establish partnerships with pharmaceutical companies to secure both near-term and long-term revenue streams. Since its creation in 2007, the group has raised EUR 8.3 million (USD 10.8 million) from private and institutional investors. The first of the two entities in the group, Alize Pharma SAS, is dedicated to a peptide (AZP-531) derived from unacylated ghrelin, which is currently at the preclinical development stage for the treatment of the Prader Willi syndrome and type II diabetes. The second entity, Alize Pharma II SAS, is focused on the development of ASPAREC(R), a new PEGylated recombinant L-asparaginase for the treatment of acute lymphoblastic leukemia, which is being co-developed with EUSA Pharma (now Jazz Pharmaceuticals) and is currently undergoing Phase I clinical trials.

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Mark Tidmarsh


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