ObsEva is evaluating long term administration of linzagolix in two dosing regimens with recruited patients for third phase of testing oral gonadotropin releasing hormone (GnRH) receptor antagonist Linzagolix for treating heavy menstrual bleeding (HMB) associated with uterine fibroids (UF), a non-cancerous tumors that grow within the muscular wall of the uterus.
The trial called PRIMROSE 2, conducted across 102 sites in the United States and Europe, will work with 500 HMB patients, related with UF. The long term treatment will be tested for up to 52 weeks.
Ernest Loumaye, Chief Executive Officer and Co-Founder of ObsEva said that the two dosing regimens will mainly get insight into the efficacy of a lower-dose of linzagolix without add-back therapy, and of a higher dose option in association with add-back therapy for patients requiring higher levels of estrogen suppression.
He expects this strategy to offer the broad patient population the personalized options needed for symptom relief with fewer side effects.
“Patient recruitment completion is an important step in this pivotal trial for the lead indication of linzagolix, a potential best-in-class oral GnRH antagonist. We anticipate the primary endpoint read out of PRIMROSE 2 in Q4 2019, in line with our development plan,” he said.
ObsEva licensed linzagolix from a Japanese pharmaceutical company Kissei, in late 2015 and retains worldwide commercial rights, excluding Asia, for linzagolix.
The company expects the primary endpoint efficacy results in Q4 2019.