Geneva's ObsEva and Japan's Kissei Pharmaceutical Co. Ltd. have entered into a collaboration agreement to develop and commercialize KLH-2109 for the treatment of endometriosis and other potential indications.
KLH-2109 is a novel, oral gonadotropin-releasing hormone (GnRH) antagonist, for which three phase 2a studies have been completed in endometriosis in Japan. Under the terms of the agreement, ObsEva will acquire the exclusive rights to develop and commercialize KLH-2109 worldwide, excluding Asia. Both companies will collaborate in parallel on the development of KLH-2109, represented in ObsEva's pipeline as OBE2109. The financial terms of the deal are not being disclosed.
KLH-2109/OBE2109 prevents the endogenous gonadotropin releasing hormone (GnRH) from activating its pituitary receptors which ultimately reduces estrogen production by the ovaries. KLH-2109 has a potentially best-in-class profile that allows partial estrogen suppression. It maintains estradiol in the low-normal range, providing symptom reduction while avoiding significant bone loss or other adverse effects that can be associated with excessive suppression of estrogen. Phase 2a studies in Japan indicate that KLH-2109 induces a dose-dependent reduction in serum LH and estradiol, resulting in a reduction of endometriosis-associated pain and bleeding days. A Phase 2b study of OBE2109 versus Placebo in endometriosis is scheduled to start mid-2016.