Soon To Be Acquired Cerevel Therapeutics Reveals High Level Data From Late-Stage Parkinson's Disease Study
Soon To Be Acquired Cerevel Therapeutics Reveals High Level Data From Late-Stage Parkinson's Disease Study
On Thursday, Cerevel Therapeutics Holdings Inc. (NASDAQ:CERE) released topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon in Parkinson's disease.
週四，Cerevel Therapeutics Holdings Inc.（納斯達克股票代碼：CERE）公佈了其針對帕金森氏病的tavapadon的關鍵性3期 TEMPO-3 試驗的主要結果。
The TEMPO-3 trial evaluated the efficacy, safety, and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults.
TEMPO-3 試驗評估了他伐帕酮作爲左旋多巴（LD）輔助療法在成人中的療效、安全性和耐受性。
The trial met its primary endpoint – patients treated with tavapadon adjunctive to LD experienced a clinically meaningful and statistically significant increase of 1.1 hours in total "on" time without troublesome dyskinesia compared to those treated with LD and placebo (1.7 hours vs. 0.6 hours, p <0.0001).
該試驗達到了其主要終點——與接受LD和安慰劑治療的患者相比，使用tavapadon輔助LD治療的患者，總的 “準時” 時間增加了1.1小時，沒有出現麻煩的運動障礙（1.7小時對0.6小時，p
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A statistically significant reduction in "off" time, the key secondary endpoint, was also observed for the tavapadon treatment arm.
還觀察到tavapadon治療組的 “關閉” 時間（關鍵的次要終點）在統計學上顯著減少。
"Tavapadon's novel mechanism of action, which selectively activates the D1/D5 dopamine receptors, has demonstrated the potential to provide people living with Parkinson's disease the right balance of motor control, safety, and tolerability," said Raymond Sanchez, M.D., chief medical officer, Cerevel Therapeutics.
Cerevel Therapeutics首席醫學官雷蒙德·桑切斯醫學博士說：“Tavapadon的新型作用機制可以選擇性地激活D1/D5多巴胺受體，已證明有可能爲帕金森氏病患者提供運動控制、安全性和耐受性之間的適當平衡。”
Tavapadon was generally well tolerated. The safety profile observed in the TEMPO-3 trial was consistent with prior clinical trials of tavapadon.
Tavapadon 的耐受性總體良好。在 TEMPO-3 試驗中觀察到的安全性特徵與之前的 tavapadon 臨床試驗一致。
The majority of adverse events reported were mild to moderate in severity.
報告的大多數不良事件的嚴重程度爲輕度至中度。
Full results from the TEMPO-3 study will be submitted for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for Parkinson's disease.
TEMPO-3 研究的完整結果將提交給未來的醫學會議，並用於支持監管機構提交的tavapadon作爲帕金森氏病治療藥物的申請。
Topline results from the Phase 3 monotherapy trials for tavapadon, TEMPO-1, and TEMPO-2 are expected in the second half of 2024.
tavapadon、TEMPO-1 和 TEMPO-2 的三期單一療法試驗的主要結果預計將在2024年下半年公佈。
In December, AbbVie Inc. (NYSE:ABBV) agreed to acquire Cerevel Therapeutics for a total equity value of approximately $8.7 billion, or $45 per share in cash. The transaction is anticipated to close in mid-2024.
12月，艾伯維公司（紐約證券交易所代碼：ABBV）同意收購Cerevel Therapeutics，總股權價值約爲87億美元，合每股現金45美元。該交易預計將於2024年中期完成。
Price Action: CERE shares are up 1.08% at $42.05 at the last check Thursday.
價格走勢：在週四的最後一次檢查中，CERE股價上漲1.08％，至42.05美元。
Photo by Milad Fakurian on Unsplash
照片由 Milad Fakurian 在 Unsplash 上拍攝
譯文內容由第三人軟體翻譯。