- Swiss biotech ObsEva has notched a clinical victory in a potentially lucrative therapeutic area within women's health, lifting company shares to a year-long high Monday morning.
- Three doses of linzagolix, an oral drug that inhibits hormones responsible for regulating ovulation, significantly reduced endometriosis pain compared to placebo, hitting the primary goal of the Phase 2b EDELWEISS trial. ObsEva is deciding which two doses to take into late-stage testing, and is looking to get regulator feedback about the design before 2019.
- ObsEva also reported its drug registered as safe and well tolerated, with hot flushes being a common and expected side effect. They were seen in 18.4% of the 75 mg dose arm and 42.1% of the 200 mg dose, versus 10.9% in the control arm.
Women's health tends not to make as many headlines as drug development areas like cancer or neuroscience do, yet unmet medical needs have made it a potentially profitable market. Grandview Research noted that the global women's health market sat at $36.5 billion in 2016, and in October predicted a compound annual growth rate of nearly 4% from 2018 to 2025.
Helping drive that evolution is endometriosis, a condition where the lining of the womb grows on the outside of the uterus. Though often-cited estimates hold that 10% of U.S. women deal with endometriosis, the Food and Drug Administration hasn't approved a new treatment for it since the late 1990s.
AbbVie appears most likely to break that trend. Its candidate elagolix, a Gonadotrophin-releasing hormone (GnRH) antagonist like linzagolix, has a target action date sometime in the third quarter.
Though the FDA delayed the drug's approval timeline so it can properly sift through patient liver function data, analysts still have high expectations. Investment bank Leerink called elagolix one of the important catalysts across biopharma remaining in 2018; and EvaluatePharma included the candidate in a recent list of the world's most valuable R&D pipeline projects — with peak annual sales projected at $1.5 billion.
ObsEva will need more time and clinical study on linzagolix before an approval application hits the desks of regulators. The EDELWEISS trial is ongoing, with 24-week data slated to come out in the fourth quarter. Elsewhere, investigators are evaluating linzagolix as a treatment for uterine fibroids in two Phase 3 studies.
The 12-week EDELWEISS data released Monday showed a response rate, meaning patients experienced at least a 30% reduction in menstrual and non-menstrual pelvic pain, of 34.5% in the placebo group. Meanwhile, the respective rates for the 75 mg, 100 mg and 200 mg groups were 61.5%, 56.4% and 56.3%. A fourth dose of 50 mg didn't significantly outperform placebo at alleviating such pains.
On a more granular level, the 200 mg dose beat the 75 mg and 100 mg doses at reducing menstrual pain. The opposite was true in non-menstrual pain — to the point where the 200 mg's effect proved not statistically significant compared to placebo.
"Keep in mind we are in the Phase 2, with a sample size of about 50 subjects," ObsEva CEO Ernest Loumaye, said during a June 18 conference call. "Therefore, I think from a statistical standpoint, it would not be the case in a larger study."
While additional work is on the horizon, investors seem much more pleased with ObsEva's direction than they were last year, when the biotech's stock plummeted in the months following its initial public offering. In February, it notched a positive readout from a Phase 3 study of another pipeline asset, its oral oxytocin receptor antagonist nolasiban.
And on the heels of this most recent data, ObsEva shares were up 24% to $18 apiece at market's open Monday, They continued to climb to a 52-week high of $19.50 later in the morning.