Exhibit 99.1
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ObsEva Announces Final Results from the Phase 3 PRIMROSE Program of
Yselty® (linzagolix) for the Treatment of Uterine Fibroids
-PRIMROSE 1 76-week results confirm PRIMROSE 2 data showing sustained post-treatment
effects and evidence of bone mineral density (BMD) recovery following 52 weeks of
treatment-
-Results continue to support the differentiated profile of Yselty with the unique low-dose
option (100 mg without add-back therapy (ABT)) and the potentially best-in-class high dose
(200 mg with ABT)-
-US NDA submission for uterine fibroids indication remains on track for submission in Q3
2021; EU MAA CHMP recommendation anticipated in Q4 2021-
GENEVA, Switzerland and BOSTON, MA (May 20, 2021) – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN) (ObsEva or the Company), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced final 76-week results from the PRIMROSE 1 clinical study of Yselty, in development for the treatment of women with heavy menstrual bleeding due to uterine fibroids. These results mark the final data measuring point for both the Phase 3 PRIMROSE 1 (US only) and PRIMROSE 2 (Europe and US) studies.
The PRIMROSE 1 and PRIMROSE 2 trials evaluated 100 mg and 200 mg doses with and without ABT. If approved, Yselty will be the only GnRH antagonist with flexible dose options that addresses the needs of three distinct groups of women suffering from uterine fibroids:
| • | | 100 mg once daily for women with a contraindication to, or preference to avoid, hormonal ABT |
| • | | 200 mg once daily with concomitant ABT for long-term use (beyond 6 months) |
| • | | 200 mg once daily for short-term use (up to 6 months) |
The PRIMROSE 1 post-treatment results are consistent with findings from the PRIMROSE 2 study, showing that off-treatment pain scores remained lower than baseline across all treatment arms. Improvements in other clinically relevant secondary endpoints, including hemoglobin levels and quality of life also persisted off-treatment, supporting the durability of the treatment effect of Yselty. Furthermore, as observed in PRIMROSE 2, the PRIMROSE 1 DXA results at Week 76 showed evidence of BMD recovery for patients treated with both the 100 mg and 200 mg+ ABT doses.
“The completion of the PRIMROSE 1 and PRIMROSE 2 clinical studies is a major achievement for the company,” said Brian O’Callaghan, CEO of ObsEva. “This milestone represents the next critical step in bringing Yselty forward as a well-differentiated, once daily oral GnRH antagonist with unique dosing options designed to treat more women with uterine fibroids. Our EU MAA review is ongoing and we continue to prepare for our US NDA submission in Q3 2021. We look forward to providing updates on our progress and sharing additional efficacy and safety data, which will be submitted for presentation at upcoming scientific conferences this year.”
Yselty® is a registered trademark owned by Kissei for use by ObsEva. Yselty® is not yet approved for use anywhere in the world.
* Add Back Therapy = 1 mg estradiol and 0.5 mg norethindrone acetate daily