Alizé’s lead drug candidate, livoletide, has reported positive Phase 2 clinical trial results in Prader-Willi Syndrome (PWS)
Leverages Millendo’s expertise to address unmet patient needs in rare endocrine diseases
ANN ARBOR, MI, USA and LYON, France I December 20, 2017 I Millendo Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing novel treatments for endocrine diseases, today announced that it has acquired Alizé Pharma SAS in a stock-based transaction.
“The acquisition of Alizé Pharma SAS transforms Millendo into an innovative endocrinology company with two first-in-class, late-stage clinical assets and a presence in both the United States and Europe. With livoletide, we have acquired a promising asset that has demonstrated encouraging efficacy and tolerability in a Phase 2 clinical trial in PWS,” said Julia C. Owens, Ph.D., President and Chief Executive Officer, Millendo Therapeutics. “Alizé Pharma’s research and development operations complement our existing expertise in developing novel treatments for orphan endocrine indications. Together with our on-going nevanimibe (ATR-101) program, which recently reported positive topline Phase 2 results in classic congenital adrenal hyperplasia, we continue to grow our leadership in the endocrinology space by advancing these promising new therapies. We look forward to sharing more details during our presentation at the J.P. Morgan Healthcare Conference next month.”
Alizé Pharma’s lead drug candidate, livoletide (previously known as AZP-531) demonstrated positive results in reducing hyperphagia in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in PWS in 2016. Livoletide has been granted orphan drug designation in PWS by the U.S. Food and Drug Administration (FDA) and has received a positive opinion from the European Medicines Agency (EMA) for orphan drug status. PWS is a rare genetic disease characterized by hyperphagia (insatiable hunger), which can lead to obesity-related complications and result in early death.
The company will operate as Millendo Therapeutics, Inc. in the United States and as Millendo Therapeutics SAS in France and Europe where it will continue to operate the former Alizé Pharma SAS facilities, maintain its capabilities and team and serve as Millendo’s European research and development base. Thierry Abribat, D.V.M., Ph.D., the founder and President of the Alizé Pharma companies, will join the Board of Directors of Millendo Therapeutics. Olivier Martinez from Bpifrance and Gilles Alberici from initiative Octalfa will be appointed as board observers.
“The commitment to developing novel treatments for patients with endocrine diseases was a key reason for this transaction and I greatly appreciate the support of the Alizé Pharma investors and team for recognizing the synergy,” said Thierry Abribat. “I look forward to working with my fellow Millendo Board members to support the company in achieving its goal of creating distinct and transformative treatments for endocrine diseases.”
About Livoletide
Livoletide (AZP-531) was evaluated in a multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial to study its effects in adults with Prader-Willi Syndrome (PWS). The study assessed food-related behaviors using the Hyperphagia Questionnaire (HQ), a 9-item disease-specific instrument that has been designed, developed and validated to capture food-related behaviors in PWS as reported by care providers. Livoletide demonstrated a statistically-significant and clinically meaningful decrease in the total HQ score for livoletide as compared to placebo. Livoletide, an analogue of unacylated ghrelin (UAG), has the potential to be a first-in-class treatment for PWS. Ghrelin, also known as acylated ghrelin, is commonly known as the “hunger hormone”. Recent studies show UAG is a separate hormone and inhibits ghrelin-induced food intake and other effects of ghrelin in vivo. Based on the clinical and preclinical data, we believe that livoletide has the potential to decrease hyperphagia and negative food-related behaviors and improve the lives of PWS patients and their care providers.
About Prader-Willi Syndrome (PWS)
Prader-Willi Syndrome (PWS) is a rare genetic disease and the most common form of genetic obesity with an estimated prevalence of 1 to 9 per 100,000. It is caused by the lack of expression of several genes on chromosome 15. The suppression of these genes leads to intellectual disability, short stature, incomplete sexual development and hyperphagia amongst other symptoms. Hyperphagia is the greatest concern as patients develop a chronic insatiable appetite early in childhood, which when coupled with a low resting energy expenditure leads to significant weight gain. Although the complications of obesity and hyperphagia are the leading causes of death, hyperphagia causes significant burden on both the patients and the care providers of PWS patients, often parents.
About Millendo Therapeutics, Inc.
Millendo Therapeutics is focused on developing novel treatments for endocrine diseases. Our mission is to build a leading endocrine company that creates distinct and transformative treatments for a wide range of diseases where there is a significant unmet medical need. We are currently advancing livoletide for the treatment of Prader-Willi Syndrome (PWS) and nevanimibe for the treatment of classic congenital adrenal hyperplasia and endogenous Cushing’s syndrome. www.millendo.com
About Alizé Pharma SAS
Before its acquisition by Millendo Therapeutics, Alizé Pharma SAS, a company of the Lyon-based Alizé Pharma group, was founded by Thierry Abribat, together with leading European endocrinologists Drs. AJ van der Lely from Erasmus Medical Center (Rotterdam, NL) and Ezio Ghigo (University of Turin, IT), in order to design and develop livoletide. Private and institutional investors of Alizé Pharma SAS, include Innobio, a fund managed by Bpifrance, Sham Innovation Santé, initiative Octalfa and CEMA Inc.
SOURCE: Millendo Therapeutics
