Euroscreen Initiates Phase I Clinical Trial For ESN364

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An Investigational Drug for the Treatment of Women’s Health Disorders

Euroscreen, a private drug development company, announced today the initiation of a Phase I clinical trial for ESN364. The main study objective is the assessment of the safety, tolerability and pharmacokinetics of ESN364 in healthy male and female volunteers. In addition, hormone levels will also be monitored as biomarkers of on-target activity. Approximately 64 healthy subjects will participate in the study. Successful completion of this European Phase I clinical trial will enable the initiation of Proof-Of-Concept Phase II studies of ESN364 in patients suffering from sex-hormone related disorders such as Endometriosis, Poly-Cystic Ovarian Syndrome (PCOS), Uterine Fibroids, and possibly other related diseases. Phase II studies are projected to start in Q4, 2014.

ESN364 is a proprietary, oral, small molecule NK3 antagonist discovered and optimized at Euroscreen. This is the first NK3 antagonist optimized for the purpose of the treatment of Women’s Health Disorders. The competitive advantage of ESN364 over the competing GnRH products is derived from its unique mechanism of action permitting modulation of the Hypothalamic-Pituitary-Gonadal (HPG) axis with a more refined and selective action on the hormones relevant to disease, and therefore promise for an improved side effect profile.

"Preclinical data have indicated that our drug candidate series represents a safe and powerful new approach to the treatment of women’s diseases, limiting side effects of existing therapies," stated Jean Combalbert, CEO. "This First In Human trial for our proprietary ESN364 reflects Euroscreen's commitment to leadership in the development of novel drugs targeting GPCR receptors.”

Clinical Need and Market Opportunity
Endometriosis and Uterine Fibroids are serious public health concerns affecting approximately 10% of women around the world. GlobalData estimates that the combined global therapeutics market by 2018 for these two indications will be $2.8 billion. These diseases are a leading cause of hysterectomies and therefore there is a high unmet need for treatments which avoid surgery. PCOS is another important disease with increasing incidence and a projected therapeutic market of $800 million by 2018. There are no broadly accepted therapies for this underserved market.

About Euroscreen
Euroscreen is a Belgium-based, private, Drug Discovery and Development company providing first-in-class small molecule drug candidates for therapeutic areas including hormonal disorders, inflammation and neurodegenerative diseases.

Euroscreen has a drug discovery track-record with multiple innovative and proprietary small-molecules targeting GPCRs.

Euroscreen is advancing its orally-available and highly specific lead program ESN364 into clinical trials for the treatment of hormonal disorders. Euroscreen is also actively seeking partners for other pharmaceutical candidates, such as its ESN282 program for the treatment of inflammatory diseases such as Ulcerative Colitis.

Euroscreen is backed by leading investors, including Vesalius Biocapital, SRIW and Fortis Private Equity.

Further information about Euroscreen and its drug discovery and development programs can be found online at or by contacting info(at)euroscreen(dot)com.

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