Bayer Highlights Detailed Data From Twin Late-Stage Trials On Experimental Menopause Candidate, Seeks Regulatory Approval
Bayer Highlights Detailed Data From Twin Late-Stage Trials On Experimental Menopause Candidate, Seeks Regulatory Approval
Bayer AG (OTC:BAYRY) (OTC:BAYZF) will present detailed results from the Phase 3 studies OASIS 1 and 2, showing that the investigational compound elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms (hot flashes) associated with menopause compared to placebo.
拜耳公司（场外交易代码：BAYRY）（场外交易代码：BAYZF）将公布OASIS 1和2的3期研究的详细结果，表明与安慰剂相比，研究中的复方艾林扎尼坦显著降低了与更年期相关的中度至重度血管舒缩症状（潮热）的频率和严重程度。
The company released the topline data showing elinzanetant met all four primary endpoints in both studies.
该公司发布的头条数据显示，在两项研究中，elinzanetant都达到了所有四个主要终点。
These data will be presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting.
这些数据将在2024年美国妇产科学会（ACOG）年度临床与科学会议上公布。
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Elinzanetant met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe VMS from baseline to week 4 and 12 compared to placebo.
Elinzanetant满足了两项研究的所有四个主要终点，表明与安慰剂相比，从基线到第4周和第12周，中度至重度VMS的频率和严重程度在统计学上显著降低。
Elinzanetant showed in OASIS 1 significant mean reductions versus placebo for frequency at week 4 with -3.29 and week 12 with -3.22 and for severity at week 4 with -0.33 and week 12 with -0.40.
与安慰剂相比，Elinzanetant在OASIS 1中显示出明显的平均值降低 频率 第 4 周为 -3.29，第 12 周为 -3.22，对于 严重程度 第 4 周为 -0.33，第 12 周为 -0.40。
In OASIS 2, elinzanetant demonstrated significant mean reductions versus placebo for frequency at week 4 with -3.04 and at week 12 with -3.24 and for severity at week 4 with -0.22 and at week 12 with -0.29.
在OASIS 2中，与安慰剂相比，elinzanetant的平均值明显降低 频率 在第 4 周使用 -3.04，在第 12 周使用 -3.24 和 严重程度 第 4 周为 -0.22，第 12 周为 -0.29。
The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups.
在这两项研究中，elinzanetant的安全性均良好，头痛和疲劳是elinzanetant组中最常见的治疗紧急不良事件（TEAE）。
In addition, elinzanetant met its key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1 and improved sleep disturbances and menopause-related quality of life compared to placebo.
此外，elinzanetant达到了其关键次要终点，与安慰剂相比，从基线到第1周，VMS的频率在统计学上显著降低，睡眠障碍和与更年期相关的生活质量有所改善。
In March, Bayer announced the topline results of the OASIS 3 Phase 3 study evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.
3月，拜耳公布了OASIS 3期3期研究的主要结果，该研究评估了在研化合物elinzanetant与安慰剂的疗效和长期安全性。
OASIS 3 is the third Phase 3 study in the OASIS clinical development program.
OASIS 3是OASIS临床开发计划的第三项3期研究。
Bayer will submit the data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for moderate to severe VMS associated with menopause.
拜耳将向卫生当局提交OASIS 1、2和3研究的数据，以批准艾林萨尼坦的上市许可，用于治疗与更年期相关的中度至重度VMS。
Photo by ClareM via Shutterstock
照片由 ClareM 通过 Shutterstock 拍摄