December 20, 2016, 7 a.m. CET – Ogeda, a clinical-stage drug discovery company that invents and develops small molecule drug candidates targeting G-protein coupled receptors (GPCRs), announces today that the World Health Organization (WHO) has recommended fezolinetant as the International Nonproprietary Name (INN) for Ogeda’s lead drug candidate ESN364.
Fezolinetant, Ogeda’s orally-available and proprietary NK3 antagonist, is currently being evaluated in several double-blind, placebo controlled Phase II clinical trials for the treatment of multiple women’s health disorders including menopausal hot flashes and polycystic ovary syndrome (PCOS).
Ogeda further announces the issuance of Patent No. US 9,422,299 entitled Substituted [1,2,4] Triazolo [4,3-A] Pyrazines as Selective NK3 Receptor Antagonists. The patent covers fezolinetant and closely related compounds as therapeutics in a broad range of diseases and disorders.
Jean Combalbert, CEO of Ogeda, said: “The recognition of fezolinetant as the INN for ESN364 and the issuance of a US patent are important milestones. With the publication of data from our Phase IIa clinical trials for the treatment of menopausal hot flashes and PCOS scheduled in 2017, fezolinetant could soon provide the first in-patient evidence of its potential to become a game changer in the non-hormonal treatment of menopausal hot flashes and the effective treatment of the cause of PCOS.”
About Ogeda
Ogeda is a Belgium-based, privately owned clinical-stage drug discovery company that invents and develops small molecule drug candidates targeting GPCRs. Ogeda’s orally-available and proprietary lead drug candidate fezolinetant (ESN364) is currently in Phase II clinical development for the treatment of women’s health disorders. Ogeda has additional small molecules targeting GPCRs in preclinical development in multiple therapeutic areas including inflammatory and autoimmune diseases. Ogeda is backed by leading investors, including Vesalius Biocapital, Fund+ and SRIW. For more information, please visit: www.ogeda.com
About fezolinetant (ESN364)
Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women’s health disorders. Fezolinetant’s mechanism of action to mimic the neuronal effects of estrogen to control body temperature supports the use of fezolinetant to directly and safely address the basis for hot flashes in menopausal women. In addition, fezolinetant addresses the cause of PCOS by selectively lowering luteinizing hormone (LH) without affecting follicle-stimulating hormone (FSH) in order to restore the correct LH-to-FSH ratio and permit the restoration of menstrual cycle regularity and fertility. Fezolinetant is also superior to the existing, marketed gonadotropin-releasing hormone (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 uterine fibroids and endometriosis.
