On January 06, ObsEva S.A. (OBSV) reported positive topline results from its Phase 3 EDELWEISS 3 Trial in endometriosis-associated pain (EAP). Consequently, the stock was trading at $2.21 apiece in the premarket at the last check.

In the previous trading session on Wednesday, the stock lost 3.29% at its closing price of $2.06. Following the news, OBSV had gained 7.28% at the time of writing.

The clinical-stage biopharmaceutical company, ObsEva S.A. has a market capitalization of $181.52 million with its 85.22 million shares outstanding.

Phase 3 EDELWEISS 3 Trial

The company has been conducting the Phase 3 Edelweiss 3 trial of linzagolix in women with moderate-to-severe EAP. The double-blind, placebo-controlled trial analyzed 484 women in Europe and the U.S. Further, the trial was designed to test the efficacy and safety of linzagolix in long term. Moreover, the study tested two doses of linzagolix; a 200 mg once-daily dose in combination with add-back therapy (ABT), and a 75 mg dose without ABT.

Endometriosis is a reproductive organs disease of women associated with a chronic inflammatory reaction, pelvic pain, and many other discomforts and disruptions. Furthermore, linzagolix is OBSV’s oral GnRH receptor antagonist which has completed its clinical trial development for uterine-fibroids associated heavy bleeding.

On January 06, the company announced positive topline data from the trial. According to the data the 200 mg dose:

• At three months, it achieved co-primary efficacy objectives with reduced dysmenorrhea (DYS) and non-menstrual pelvic pains (NMPP) at 3 months.
• The first five secondary endpoints also showed statistically significant and clinically meaningful improvements at 6 months.

According to the 75 mg dose of linzagolix without ABT data:

• Statistically significant reduction was demonstrated in DYS against the placebo at three months.
• Did not reach co-primary efficacy objective but did show improvement in NMPP at three months.
• Showed improvements in the first five secondary endpoints at six months like the 200 mg dose.

In addition, both the doses demonstrated general well-tolerability with few adverse events.

OBSV’s Other Developments

Recently, the company announced its participation at the upcoming H.C. Wainwright BioConnect Conference. OBSV’s management will be providing the company’s corporate updates at the conference which is taking place from January 10 to 13, 2022.

Previously, the company had announced its selection for addition to the NASDAQ Biotechnology Index (NBI). This addition was effective on Monday, December 20, 2021, at the opening of the market.