Euroscreen completes enrollment in Phase II trial of lead candidate ESN364 in Menopausal Hot Flashes
Study evaluating ESN364, a novel, non-hormonal small-molecule drug designed to block Hot Flashes avoiding Hormone Replacement Therapy (HRT), known to increase the incidence of cancer in menopausal women.
September 14, 2016 – Euroscreen announced today that it has completed enrollment for its Phase II proof-of-concept clinical study designed to evaluate ESN364, an oral, small molecule NK3 antagonist, for the treatment of Menopausal Hot Flashes.
The double-blind, placebo controlled 12-week study will measure the efficacy of ESN364 in reducing the severity and frequency of Menopausal Hot Flashes in symptomatic menopausal women. The study has enrolled a total of 87 patients at various clinical sites in Belgium and final data are expected by year end 2016.
ESN364 has already successfully completed a Phase I study in men and women demonstrating an excellent safety profile as well as clear drug efficacy on hormone biomarkers. In addition, pre-clinical proof-of-concept studies have shown the ability of ESN364 to specifically block the occurrence of Hot Flashes.
The Phase IIa trial in Menopausal Hot Flashes forms part of a broad program in women’s health, alongside two ongoing Phase IIa clinical trials evaluating ESN364 for the treatment of PolyCystic Ovary Syndrome (PCOS) and Uterine Fibroids (UF). ESN364 has already shown to be devoid of Hot Flash side effects commonly observed with GnRH therapies.
“We are encouraged by the interest shown by patients and physicians in this trial as this non-hormonal drug candidate offers an important alternative to estrogen-based drugs presently used to treat severe hot flashes.” said Dr. Steven Ramael, Euroscreen’s Medical Director.
Jean Combalbert, CEO of Euroscreen said: “There is a clear need for better, non-hormonal treatments for Menopausal Hot Flashes. We look forward to completing this trial and building on the strong data seen so far to support the development of ESN364 in this important indication.”
About Hot Flashes
Hot Flashes are the major medical complaint coincident with menopause. 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 is a Belgium-based, privately owned Drug Discovery Company developing first-in-class small molecule drug candidates targeting G-Protein Coupled Receptors (GPCRs). The Company’s orally-available and highly specific lead product ESN364 is currently in Phase II clinical development for the treatment of Women’s Health Disorders. Euroscreen has other small molecules targeting GPCRs in preclinical development in multiple therapeutic areas including CNS, endocrinology and inflammation. Euroscreen is backed by leading investors, including Vesalius Biocapital, SRIW, SFPI-FPIM, and Fund+. www.euroscreen.com
Chief Financial Officer
+32 71 348 511
Director Business Development
+1 716 308 6693
Consilium Strategic Communications
Chris Gardner, Jonathan Birt, Hendrik Thys and Melissa Gardiner
+44 20 3709 5700
Euroscreen opens US-IND for ESN364 on three Phase II trialsRead more