Our Pipeline

OBE2109

OBE2109—Uterine Fibroids

In 2015, ObsEva in-licensed OBE2109 for the treatment of endometriosis from Kissei Pharmaceutical Co. In the first half of 2017, ObsEva intends to commence two Phase 3 clinical trials of OBE2109 in women with heavy menstrual bleeding (HMB) associated with uterine fibroids (UF).

OBE2109 is a novel, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that potentially provides effective management of UF-associated HMB while mitigating bone mineral density loss and other adverse effects typically associated with currently approved treatments. Unlike many currently marketed GnRH agonists, OBE2109 has the potential to be administered orally once a day, with symptoms relieved within days, while potentially mitigating the initial worsening of symptoms often associated with GnRH agonist treatments. In contrast to other GnRH receptor antagonists in development, OBE2109 has innovative properties that have the potential to allow for personalized dosing that can be tailored to a patient’s individual response. This means that OBE2109 has the potential to lower estradiol levels while maintaining such levels within an optimal range to mitigate patient bone mineral density loss. OBE2109 has the potential to allow patients to receive the relief needed to live normal lives again and enhance their quality of life with fewer side effects and complications requiring doctor’s visits or surgery.

In a Phase 2a clinical trial, which included a subgroup of patients with both endometriosis and UF, OBE2109 provided significant, dose-dependent decreases in serum LH and estradiol levels in UF patients. This resulted in the reduction of bleeding days within the first month of treatment (>90 percent of patients) and anemia correction within three months (>90 percent of patients) of treatment.

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OBE2109—Endometriosis

In 2015, ObsEva in-licensed OBE2109 from Kissei Pharmaceutical Co., which had completed several Phase 2a clinical trials in Japan.

OBE2109 is a novel, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that potentially provides effective management of endometriosis-associated pain while mitigating bone mineral density loss and other adverse effects typically associated with currently approved treatments. Unlike many currently marketed GnRH agonists, OBE2109 has the potential to be administered orally once a day, with symptoms relieved within days, while potentially mitigating the initial worsening of symptoms often associated with GnRH agonist treatments. In contrast to other GnRH receptor antagonists in development, OBE2109 has innovative properties that have the potential to allow for personalized dosing that can be tailored to a patient’s individual response. This means that OBE2109 has the potential to lower estradiol levels while maintaining such levels within an optimal range to mitigate patient bone mineral density loss. OBE2109 has the potential to allow patients to receive the relief needed to live normal lives again and enhance their quality of life with fewer side effects and complications requiring doctor’s visits or surgery.

In a Phase 2a clinical trial, OBE2109 provided significant, dose-dependent decreases in serum LH and estradiol levels in patients with endometriosis. These patients experienced a reduction of disease-associated pain and bleeding days, as well as improved quality of life (>85 percent). The use of OBE2109 also led to a significant dose-dependent reduction in the use of pain medication to manage endometriosis symptoms, as compared to patients in the placebo group. A Phase 2b clinical trial of OBE2109 as compared to placebo in endometriosis is now underway in the US and Europe.

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