Gosselies, Belgium (PRWEB) April 21, 2015
Euroscreen SA announced today it has initiated two Phase 2 Proof-of-Concept studies in UF and PCOS with ESN364, a novel treatment for Women’s Health Disorders. In Phase 1 studies, ESN364 showed excellent safety and tolerability, and drug-like pharmacokinetic properties. The launch of these two Phase 2 trials builds upon the efficacy data established in Phase 1 wherein ESN364 lowered plasma levels of estrogen and progesterone as a result of its selective effect on pulsatile LH secretion. The demonstrated selective modulation of gonadotropins mitigates the risk of the induction of menopausal-like adverse events, such as loss of bone mineral density and the induction of hot flashes. Thus, in contrast to the existing GnRH products, the non-castrating drug profile of ESN364 presents an opportunity for chronic dosing without any need for add-back therapy for the chronic treatment of Women’s Health Disorders.
"These Phase II studies are pivotal for this flagship product and will induce a tremendous increase of value of our company. We look forward to demonstrate ESN364's ability to produce a sustained control of critical hormone levels enabling disease control over long-term in patients. We expect ESN364 to be a game-changer in the treatment for patients suffering from a number of serious Women’s Health Disorders," said Jean Combalbert, CEO of Euroscreen.
Details on Phase 2 clinical studies
These two clinical Proof-of-Concept Phase 2 trials are double blind, randomized, multicenter, placebo-controlled studies exploring the effects of two dose levels of ESN364 on the primary outcome parameters. For each trial, the outcome parameters have been chosen to reflect desired, objective clinical outcomes, namely, uterine blood loss and uterine fibroids growth in UF, and hyper-androgenism in PCOS. These trials will recruit patients in multiple sites in 4 countries: Austria, Belgium, Germany, and the Netherlands. Both trials are anticipated to conclude in Q3 2016.
About UF and PCOS
Uterine Fibroids are benign tumors that originate from the smooth muscle layer of the uterus. Fibroids are the most common benign tumors in females and typically found during the middle and later reproductive years. Uterine fibroids are an important cause of heavy, prolonged and painful menstruation, painful sexual intercourse, pelvic pressure, frequent urination and difficulty emptying bladder, constipation and backache or leg pains. Symptoms caused by uterine fibroids are a very frequent indication for surgical removal of the uterus. About 70% of women will be diagnosed at some point in their life but only 20-40% of those will cause symptoms or require treatment. Fibroids are dependent on estrogen and progesterone to grow and therefore may be effectively treated by products lowering the levels of theses ovarian hormones.
Poly Cystic Ovarian Syndrome is a set of symptoms arising from high androgen levels. Symptoms include: irregular or no menstrual periods, excess body and facial hair, acne, pelvic pain, and fertility problems. Associated conditions include: type 2 diabetes, obesity, obstructive sleep apnea, heart disease, mood disorders, and endometrial cancer. Diagnosis is based on two of the following three findings: oligo- or anovulation, high androgen levels, and presence of ovarian cysts. PCOS has no cure. Treatment may involve lifestyle changes such as weight loss and exercise. PCOS is the most common endocrine disorder among women between the ages of 18 and 45, it affects approximately 5% to 10% of this age group; it is one of the leading causes of poor fertility.
ESN364 is a proprietary, oral, small-molecule, discovered and optimized by Euroscreen for the purpose of the treatment of Women’s Health Disorders. Whereas competing GnRH ligand products block signaling entirely, ESN364 merely decreases GnRH pulse frequency and thereby decreases LH pulse frequency without affecting FSH. Its selective drug action 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; and uniquely positions ESN364 for the treatment of PCOS.
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 targeting GPCRs. 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 GPCRs of interest in multiple therapeutic areas such as neurodegenerative diseases and inflammation. Euroscreen is backed by leading investors, including Vesalius Biocapital, SRIW and Fortis Private Equity. Further information about Euroscreen can be found online at http://www.euroscreen.com.