Gosselies, Belgium (PRWEB) September 23, 2015
Euroscreen SA announced today that it has initiated a Phase 2 clinical study for the treatment of menopausal Hot Flashes with ESN364, a new drug for Women’s Health Disorders. The main objective of this clinical trial is to measure the efficacy of ESN364 on the severity and frequency of menopausal Hot Flashes. This double-blind, placebo-controlled, 3-month study is being carried out in 80 symptomatic menopausal women at various clinical sites in Belgium. Hot Flashes are the major medical complaint coincident with menopause.
ESN364 has already completed Phase 1 in men and women having demonstrated an excellent safety profile as well as clear drug efficacy on hormone biomarkers. This trial in Hot Flashes is performed in parallel of two ongoing, 3-month, Phase 2 clinical trials evaluating ESN364 for the treatment of Uterine Fibroids (UF) and PolyCystic Ovary Syndrome (PCOS). ESN364 has already demonstrated to be devoid of Hot Flash side effects commonly observed with GnRH therapies. In addition, during preclinical development we demonstrated in animal proof-of-concept studies the ability of ESN364 ability to specifically block the occurrence of Hot Flashes.
“The unique mechanism of action of ESN364 forms the scientific basis of its potential to safely and effectively treat Hot Flashes” said Prof. Herman Depypere (Ghent University), member of the EMAS (European Menopause & Andropause Society), former President of the Belgian Menopause Society, and member of Euroscreen's Clinical Advisory Board.
“Encouraged by our recent additional new funds raised, we decided to fund this additional Phase 2 trial; we expect ESN364 to be a game-changer in the treatment of menopausal Hot Flashes, giving us the opportunity to reach this huge and valuable market. The next 12-month period promises to be an exciting time for Euroscreen as ESN364 completes Phase 2 trials in multiple indications” said Jean Combalbert, CEO of Euroscreen.
About Hot Flashes
Hot Flashes are the sudden feelings of intense heat which are usually most intense over the face, neck and chest and can include skin reddening, blushing and profuse sweating. This may occur due to specific drug actions, but are most commonly experienced by 70% of menopausal women. Hormone Replacement Therapy (HRT) approaches have been used to address this medical need, however, HRT approaches are known to increase the incidence of cancer, heart disease and stroke in menopausal women. Thus, there is an important medical need for new, safe therapies.
ESN364 is a proprietary, oral, small-molecule, discovered and developed by Euroscreen for the purpose of the treatment of Women’s Health Disorders. ESN364 is superior to the existing, marketed GnRH ligands as it reduces levels of the ovarian hormones estrogen and progesterone in a non-castrating manner as required for the safe, effective treatment of UF and Endometriosis. In addition, its selective action on gonadotropins uniquely positions ESN364 for the treatment of PCOS. Furthermore, its mechanism of action to mimic the neuronal effects of estrogen to control body temperature supports the use of ESN364 to directly and safely address the basis for Hot Flashes in menopausal women.
Euroscreen S.A. is a Belgium-based, private, Drug Discovery and Development company providing first-in-class small molecule drug candidates for unmet medical needs. Euroscreen has a drug discovery track-record with multiple innovative and proprietary small-molecules. Euroscreen has advanced its orally-available and highly specific lead program ESN364 into clinical development for the treatment of Women’s Health Disorders. In addition, Euroscreen advances other small molecules (preclinical stage) targeting G-Protein Coupled Receptors of interest in multiple therapeutic areas such as neurodegenerative diseases and inflammation. Euroscreen is backed by leading investors, including Vesalius Biocapital, SFPI, SRIW, Fund+ and BNP Paribas Fortis Private Equity. Further information about Euroscreen can be found online at http://www.euroscreen.com