Bayer's Third Menopausal Relief Drug Trial Meets Primary Goal, German Conglomerate Seeks FDA Approval For Elinzanetant
Bayer's Third Menopausal Relief Drug Trial Meets Primary Goal, German Conglomerate Seeks FDA Approval For Elinzanetant
Tuesday, Bayer AG (OTC:BAYRY) (OTC:BAYZF) announced topline results of the Phase 3 study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.
週二，拜耳公司（場外交易代碼：BAYRY）（場外交易代碼：BAYZF）公佈了評估在研化合物艾林扎奈坦與安慰劑對比的療效和長期安全性的3期研究OASIS 3的主要結果。
In this study, elinzanetant met the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 12 compared to placebo.
在這項研究中，elinzanetant達到了主要終點，表明與安慰劑相比，從基線到第12周，中度至重度血管舒縮症狀（VMS，也稱爲潮熱）的頻率在統計學上顯著降低。
The long-term safety profile observed over 52 weeks in the OASIS 3 study is consistent with previously conducted studies and published data on elinzanetant.
在OASIS 3研究中觀察到的超過52周的長期安全性概況與先前進行的研究和已發佈的有關艾林扎尼坦的數據一致。
Elinzanetant is the first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.
Elinzanetant是第一種雙神經激素-1,3（NK-1,3）受體拮抗劑，處於後期臨床開發階段，用於非激素治療與更年期相關的中度至重度VMS，每天口服一次。
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。
In early 2024, Bayer announced topline data of the first two Phase 3 studies OASIS 1 and 2.
2024年初，拜耳公佈了前兩項3期研究OASIS 1和2的頭條數據。
Elinzanetant met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms from baseline to week 4 and 12 compared to placebo.
Elinzanetant符合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，中度至重度血管舒縮症狀的頻率和嚴重程度在統計學上顯著降低。
Both studies also achieved all three key secondary endpoints, showing a statistically significant reduction in the frequency of VMS from baseline to week 1 and statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo.
兩項研究還實現了所有三個關鍵次要終點，顯示與安慰劑相比，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也有統計學上的顯著改善。
Reuters highlighted that Bayer previously estimated the blood-thinning drug could have peak annual sales of more than €5 billion, and the menopause drug elinzanetant was given the potential of about a billion dollars or more per year.
路透社強調，拜耳此前估計，這種血液稀釋藥物的峯值年銷售額可能超過50億歐元，而更年期藥物elinzanetant的年銷售額可能達到約10億美元或更多。
Last year, Acer Therapeutics Inc's (OTC:ACER) Phase 2a proof of concept clinical trial of ACER-801 (osanetant) as a potential treatment for moderate to severe VMS associated with menopause did not achieve statistical significance to decrease the frequency or severity of hot flashes in postmenopausal women.
去年，Acer Therapeutics Inc（場外交易代碼：ACER）對作爲與更年期相關的中度至重度VMS的潛在治療方法的 ACER-801（osanetant）的2a期概念驗證臨床試驗沒有達到統計學意義，無法降低絕經後女性潮熱的頻率或嚴重程度。
Photo by ClareM via Shutterstock
照片由 ClareM 通過 Shutterstock 拍攝
譯文內容由第三人軟體翻譯。