The uterine fibroid drug linzagolix two stage 3 clinical results were positive.

ObsEva SA, a biopharmaceutical company that develops and sells new treatments to improve women's reproductive health, announced the positive results of two Phase 3 clinical trials (PRIMROSE 1 and PRIMROSE 2) for the treatment of uterine fibroids by its star product, Lin®zagolix. two studies

evaluated the efficacy and safety of linzagolix in women with uterine fibroids that cause large bleeding during menstruation.
the PRIMROSE 1 trial reached the primary endpoint at week 24, and the results showed a statistically and clinically significant reduction in blood reduction in patients receiving linzagolix compared to placebo (s.80mL, 50% lower than the baseline).
women who received 200 mg linzagolix and reverse aphrates (ABT) had a remission rate of 75.5% (P 0.001) and 56.4% of women receiving 100 mg linzagolix and not ABT (P-0.003).
24-week aggregate data from two phase III studies also supported the efficacy of linzagolix, with an response rate of 84.7 per cent for 200 mg linzagolix combined with ABT, compared with 56.6 per cent for 100 mg linzagolix not combined with ABT.
PRIMROSE 2 data show that continuous treatment with linzagolix for 52 weeks provides consistent efficacy for patients and is well tolerated.
observed response rates of 91.6% and 53.2% in patients who received 200 mg linzagolix combined ABT and 100 mg linzagolix without ABT.
in two studies, patients who received linzagolix had significant statistical lying at many clinically relevant secondary endpoints, including pain reduction, improved anemia and quality of life.
adverse reactions, in the PRIMROSE 1 trial, the rate of adverse events was similar between the placebo group and the treatment group. the most common adverse events
were headaches and hot flashes, with an incidence rate of more than 5%.
, at week 24, a slight change in the mineral density (BMD) of the lumbar vertebral bone was observed in both groups.
in PRIMROSE 2, the most common adverse events are headache, hot flashes and anemia, with an incidence rate of more than 5%.
observed a slight incremental change in patientBMD at week 52 compared to week 24. Dr. Hugh Taylor, a professor at Yale University School of Medicine at
, said: "It's great to see these results that demonstrate that both of linzagolix's options effectively control bleeding, reduce fibroid-related pain, and improve anemia.
Linzagolix is expected to offer a long-awaited medical solution to address the currentun-unmet clinical needs.
" Linzagolix is a new oral GnRH receptor antagonist that eventually reduces estrogen production in the ovaries by binding and blocking GnRH receptors in the pituitary gland.
ObsEva is prepared to submit regulatory applications to European and U.S. regulators in the fourth quarter of 2020 and January 2021, respectively.
Reference Source: ObsEva Announces Positive Results from Two Phase3 Studies, PRIMROSE 1 and 2, of the Yselty ® (Linzagolix) for the Treatment of The Seuterine Fibroids.