Roche-Prothena Partnered Mid-Stage Parkinson's Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits
Roche-Prothena Partnered Mid-Stage Parkinson's Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits
The companies said the effect of prasinezumab was more pronounced in a pre-specified analysis in the population treated with levodopa (75% of participants), HR=0.79 and nominal p=0.0431.On Thursday, Prothena Corporation plc (NASDAQ:PRTA) released results from the Phase 2b PADOVA study of prasinezumab in early-stage Parkinson's disease.
週四，Prothena公司（納斯達克：PRTA）發佈了在早期帕金森病患者中進行的20億PADOVA研究中prasinezumab的結果。
Partner Roche Holdings AG (OTC:RHHBY) conducted the 586-subject study investigating prasinezumab in early-stage Parkinson's disease patients who had been treated for a minimum of 18 months while on stable symptomatic treatment.
合作伙伴羅氏控股公司（場外交易：RHHBY）進行了一項586名受試者的研究，調查在穩定症狀治療下接受至少18個月治療的早期帕金森病患者的prasinezumab。
Prasinezumab showed a potential clinical effect in the primary endpoint of time to confirmed motor progression with an HR=0.84 and p=0.0657, missing statistical significance.
Prasinezumab在確認運動進展的主要終點上顯示出潛在的臨床效果，HR=0.84，p=0.0657，但未達到統計學顯著性。
The companies said the effect of prasinezumab was more pronounced in a pre-specified analysis in the population treated with levodopa (75% of participants), HR=0.79 and nominal p=0.0431.
兩家公司表示，在接受左旋多巴治療的預先指定人群分析中，prasinezumab的效果更爲明顯（75%的參與者），HR=0.79，名義p=0.0431。
Pre-specified supplementary covariate-adjusted analyses of these endpoints demonstrated nominally significant effects on the primary endpoint (HR=0.81; nominal p=0.0334) and in the levodopa subgroup (HR=0.76; nominal p=0.0175).
對這些終點的預先指定的補充協變量調整分析顯示出在主要終點（HR=0.81；名義p=0.0334）和左旋多巴亞組（HR=0.76；名義p=0.0175）的名義顯著效果。
Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Prasinezumab continues to be well tolerated, and no new safety signals were observed in the study.
在多個次要和探索性終點上也觀察到了持續的積極趨勢。Prasinezumab繼續表現出良好的耐受性，研究中未觀察到新的安全信號。
The Phase 2 PASADENA and Phase 2b PADOVA open-label extension studies will continue to explore the observed effects in both studies.
第二階段PASADENA和20億PADOVA開放標籤擴展研究將繼續探索這兩項研究中觀察到的效果。
Roche will continue to evaluate the data and work together with health authorities to determine the next steps.
羅氏將繼續評估數據，並與衛生機構合作判斷下一步的措施。
Full results from the PADOVA study will be presented at an upcoming medical meeting.
PADOVA研究的全面結果將在即將召開的醫療會議上公佈。
Price Action: PRTA stock is up 32.40% at $15.83 at the last check on Thursday.
價格走勢：PRTA股票在週四的最後一次檢查中上漲了32.40%，至$15.83。
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譯文內容由第三人軟體翻譯。