Ernest Loumaye, chief executive officer of Switzerland-based ObsEva, is excited about the potential opportunity to provide women a significant treatment for endometriosis-associated pain.
Ernest Loumaye, chief executive officer of Switzerland-based ObsEva, is excited about the potential opportunity to provide women a significant treatment for endometriosis-associated pain.
This morning the company, which has offices in Switzerland and Boston, released positive Phase IIb data for linzagolix, the company’s oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of endometriosis-associated pain. In addition to a significant 30 percent reduction in pain associated with endometriosis, the Phase IIb study (EDELWEISS) showed that doses of linzagolix from 75mg to 200mg “significantly and consistently improved dyschezia and patient well-being,” according to a survey. The two dosing levels will be studied in an upcoming Phase III program, one for full estradiol (E2) suppression and one targeting partial suppression. Loumaye told BioSpace over the weekend that ObsEva hopes to initiate the Phase III study by the end of 2018. Before it can launch the trial, Loumaye said the company needs to collect six-month follow-up data from the Phase IIb trial. The data, which includes a bone mineral density (BMD) assessment, should be available in September. That bone mineral density (BMD) assessment will confirm dosing, he said.
“We believe that these data strongly support the therapeutic potential of linzagolix for improving the condition and well-being of patients suffering from endometriosis. In addition, we believe these data further confirm ObsEva’s vision and product development strategy that a significant proportion of patients will not require full E2 suppression which mandates add-back hormone replacement therapy. With these data, we reiterate our intention to move to Phase 3 by the end of the year with two doses of linzagolix,” Loumaye said.
Endometriosis occurs when tissue similar to that normally found in the uterus begins to grow outside of the uterus, leading to long-term pelvic pain (during or between periods), pain with intercourse and other painful symptoms. Linzagolix is part of a new class of drugs that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. As ObsEva prepares for a Phase III trial, Illinois-based AbbVie is awaiting a decision by the U.S. Food and Drug Administration (FDA) for approval of its GnRH inhibitor, elagolix. The FDA is expected to rule on the AbbVie endometriosis-associated pain treatment in the third quarter of this year.
If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade. Analysts predict elagolix could become a blockbuster treatment by 2022. Loumaye said AbbVie will hit the market with its oral GnRH receptor antagonist before ObsEva. However, he remains confident that there is a broad enough patient population for multiple treatments.
“We see it positively. It’s a new class of drug and there’s room in the space. It’s a really a nasty and painful condition,” Loumaye said.
While there is room in the space, Loumaye said he believes the two drugs are comparable, but noted he believes that the pharmacological profile of linzagolix makes it a potentially best-in-class treatment, particularly due to a longer half-life.
In addition to its endometriosis treatment, ObsEva is also pushing forward with additional late-stage studies for its fertility treatment nolasiban. In February the company released late-stage data that showed nolasiban, an oral oxytocin receptor antagonist, was successful in improving the pregnancy rate of some women following in vitro fertilization. Follow-up data from the study will include live birth rate and 28-day neonatal safety. The information will be reported in the fourth quarter of this year. Six-month infant follow-up is expected to be available in 2019. The company anticipates launching another Phase III in the United States and could eye earlier attempts at seeking approval in Europe later this year, Loumaye said.
In addition to linzagolix and nolasiban, ObsEva is also developing a treatment to help stop contractions in preterm labor. The experimental product is currently in a Phase IIa in Finland and Spain. Loumaye expects an interim analysis of trial data by the end of the year.
