Gosselies, Belgium (PRWEB) July 19, 2016
Euroscreen announced today that it has opened an Investigational Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to conduct pivotal efficacy and safety assessments to evaluate ESN364 in Phase II studies for the treatment of menopausal Hot Flashes, Poly Cystic Ovary Syndrome and Uterine Fibroids.
“The opening of these three IND applications is a major milestone for the Company as we progress in the clinical development of ESN364” said Jean Combalbert, CEO of Euroscreen. “Our initial correspondence with the FDA has been very positive and Euroscreen is looking forward to continue working with the agency and other experts to further develop our lead compound in the US. These three INDs, on top of the three clinical studies currently running in Europe, position the company for major future milestones.”
ESN364 is a proprietary, small-molecule NK3 receptor antagonist discovered and developed by Euroscreen, and it is the most advanced product in its target class in clinical development for the treatment of Women’s Health Disorders. The mechanism-of-action of ESN364 offers an advantage over existing therapies for Uterine Fibroids and Endometriosis known to elicit menopause-like adverse events. Moreover, the action of ESN364 to selectively modulate gonadotropins uniquely suits this product for the treatment of Poly Cystic Ovary Syndrome. In addition, ESN364 is a game-changer as the non-hormonal treatment for Hot Flashes, providing an alternative to Hormone Replacement Therapy (HRT).
Euroscreen is a Belgium-based, privately owned Drug Discovery Company developing first-in-class small molecule drug candidates targeting G-Protein Coupled Receptors. 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 G-Protein Coupled Receptors 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+. http://www.euroscreen.com
Ruth Devenyns Al Gray
CFO Director Business Development
+32 71 348 511 +1 716 308 6693