[{"orgOrder":0,"company":"ObsEva","sponsor":"Yuyuan BioScience Technology","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ObsEva and Yuyuan BioScience Technology Announce Sublicense Agreement to Develop and Commercialize Nolasiban in the People's Republic of China","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"ObsEva"},{"orgOrder":0,"company":"ObsEva","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ObsEva Announces Publication of Abstracts from Phase 2b EDELWEISS Trial of Linzagolix in Endometriosis\n","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase 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Under the termination of agreement with Yuyuan, ObsEva recovered full worldwide rights on OBE001 (nolasiban), a novel, oral oxytocin receptor antagonist being developed to improve pregnancy and live birth rates in women undergoing embryo transfer after in vitro fertilization.
Nolasiban (OBE001), an oral oxytocin receptor antagonist with the potential to decrease contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation. This increases the chance of successful pregnancy and live-birth.
Summary of data and key takeaway: At 12 weeks, once-daily treatment with Yselty (linzagolix 200 mg) with hormonal ABT significantly improved dysmenorrhea, non-menstrual pelvic pain, and other symptoms of endometriosis, including dyschezia and ability to do daily activities.
Results demonstrated that OBE-2109 (linzagolix) has potential to balance safety, efficacy, and address wide-ranging symptoms of uterine fibroids also showed promise in delivering sustained clinical benefit.
ObsEva has entered into a licensing agreement with Theramex to support the commercialization and market introduction of linzagolix in Europe. Theramex’s extensive women’s health commercial infrastructure includes a dedicated sales force of more than 180 representatives.
Both DYS and NMPP showed rapid reductions compared to placebo (after 1 and 2 months of treatment), with continued reduction up to 6 months of treatment and with higher reductions with linzagolix, an oral GnRH antagonist, 200 mg + ABT compared to linzagolix 75 mg.
The data from the Phase 3 PRIMROSE studies of Yselty (linzagolix) for the treatment of uterine fibroids demonstrating sustained safety and efficacy results at 52 weeks.
Study on trial of Linzagolix investigated that efficacy and safety of two dosing regimens, 100mg once daily and 200mg once daily, alone or in combination with hormonal ABT for the treatment of heavy menstrual bleeding associated with uterine fibroids.
Linzagolix is the only GnRH antagonist to provide flexible dosing options to better address the individual needs of patients, and the results further underscore its differentiated profile and potential clinical utility.
The data presented further substantiate the best-in-class potential of linzagolix for the treatment of heavy menstrual bleeding (HMB) due to uterine fibroids addressing both key efficacy and safety parameters from the PRIMROSE Phase 3 program.