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（場外交易代碼：BAYRY）（場外交易代碼：BAYZF）將公佈OASIS 1和2的3期研究的詳細結果，表明與安慰劑相比，研究中的複方艾林扎尼坦顯著降低了與更年期相關的中度至重度血管舒縮症狀（潮熱）的頻率和嚴重程度。
The company released the topline data showing elinzanetant met all four primary endpoints in both studies.
該公司發佈的頭條數據顯示，在兩項研究中，elinzanetant都達到了所有四個主要終點。
These data will be presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting.
這些數據將在2024年美國婦產科學會（ACOG）年度臨床與科學會議上公佈。
Related: German Conglomerate Bayer Goes Johnson & Johnson Way To Tackle Its Cancer Related Lawsuits.
相關： 德國拜耳集團採取強生公司的方法來解決其癌症相關訴訟。
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滿足了兩項研究的所有四個主要終點，表明與安慰劑相比，從基線到第4周和第12周，中度至重度VMS的頻率和嚴重程度在統計學上顯著降低。
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.
與安慰劑相比，Elinzanetant在OASIS 1中顯示出明顯的平均值降低 頻率 第 4 周爲 -3.29，第 12 周爲 -3.22，對於 嚴重程度 第 4 周爲 -0.33，第 12 周爲 -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，與安慰劑相比，elinzanetant的平均值明顯降低 頻率 在第 4 周使用 -3.04，在第 12 周使用 -3.24 和 嚴重程度 第 4 周爲 -0.22，第 12 周爲 -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.
在這兩項研究中，elinzanetant的安全性均良好，頭痛和疲勞是elinzanetant組中最常見的治療緊急不良事件（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達到了其關鍵次要終點，與安慰劑相比，從基線到第1周，VMS的頻率在統計學上顯著降低，睡眠障礙和與更年期相關的生活質量有所改善。
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，拜耳公佈了OASIS 3期3期研究的主要結果，該研究評估了在研化合物elinzanetant與安慰劑的療效和長期安全性。
OASIS 3 is the third Phase 3 study in the OASIS clinical development program.
OASIS 3是OASIS臨床開發計劃的第三項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.
拜耳將向衛生當局提交OASIS 1、2和3研究的數據，以批准艾林薩尼坦的上市許可，用於治療與更年期相關的中度至重度VMS。
Photo by ClareM via Shutterstock
照片由 ClareM 通過 Shutterstock 拍攝