Gilead Unveils Long-Term Data From Seladelpar In Patients With Rare Liver Disease
Gilead Unveils Long-Term Data From Seladelpar In Patients With Rare Liver Disease
On Friday, Gilead Sciences, Inc. (NASDAQ:GILD) revealed data from a two-and-a-half-year interim analysis from the ongoing Phase 3 ASSURE study evaluating the long-term efficacy and safety of Livdelzi.
在週五，吉利德科學公司（納斯達克：GILD）公佈了來自進行中的第三階段ASSURE研究的爲期兩年半的中期分析數據，該研究評估了Livdelzi的長期療效和安全性。
The study showed that 81% (30 out of 37) of participants with primary biliary cholangitis (PBC) treated with Livdelzi (seladelpar) achieved a composite biochemical response (CBR), demonstrating significant improvements in a key measures of PBC progression.
研究表明，81%(37人中的30人)接受Livdelzi (seladelpar)治療原發性膽汁性肝炎(PBC)的參與者達到了複合生化反應(CBR)，顯示在PBC進展關鍵指標方面有顯著改善。
Additionally, 41% (15 out of 37) of participants achieved normalization of alkaline phosphatase (ALP) levels, a critical biomarker of liver function.
此外，41%(37人中的15人)的參與者達到了鹼性磷酸酶(ALP)水平的正常化，這是肝功能的關鍵生物標誌物。
Also Read: HIV Drugmaker Gilead Reports Strongest Quarterly Performance Of 2024, Analysts Boost Price Target On Raised Outlook
另請閱讀：HIV藥廠吉利德報告2024年表現最強勁的季度業績，分析師根據提高的展望提高目標價。
Livdelzi continues to appear generally well tolerated, with no new safety signals or change in frequency of adverse events (AEs) with up to three years of exposure.
Livdelzi繼續表現出總體耐受良好的特點，長達三年的暴露期間沒有新的安全信號或不良事件(AEs)發生頻率的變化。
In August, the FDA granted accelerated approval for Gilead's Livdelzi for primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
今年8月，FDA授予吉利德的Livdelzi在與羥基膽酸(UDCA)聯合治療原發性膽汁性肝炎的成年患者獲得加速批准，這些患者對UDCA反應不佳或作爲單藥療法用於不能耐受UDCA的患者。
In addition to the ASSURE data, Gilead showcased findings from two oral presentations highlighting additional analyses from the Phase 3 RESPONSE trial:
除了ASSURE數據外，吉利德還展示了來自第3期RESPONSE試驗的額外分析的兩項口頭報告結果：
- At Month 12, the adjusted mean change from baseline in ALP for participants with cirrhosis on Livdelzi was -121.4 U/L (a decrease of approximately 35% from baseline) versus 23.2 U/L (an increase of approximately 6.6%) on placebo.
- -134.8 U/L (down 43.5%) for Livdelzi versus -18.0 U/L (a decrease of approximately 5.8%) for placebo in participants without cirrhosis.
- A secondary analysis of pruritus in RESPONSE showed that among participants with a numerical rating score (NRS) of ≥4 and NRS ≥7 at baseline, Livdelzi led to near resolution (NRS of 0 or 1) of itch at Month 12 in 26.5% and 18.8% of participants, respectively, versus 0% of participants on placebo.
- 在第12個月，肝硬化患者Livdelzi基線的ALP平均調整變化爲-121.4 U/L(從基線上下降約35%)，而安慰劑組爲23.2 U/L(增加約6.6%)。
- Livdelzi組與無肝硬化參與者的安慰劑組相比，-134.8 U/L（下降43.5%）與-18.0 U/L（下降約5.8%）。
- RESPONSE的瘙癢性繼發分析顯示，在基線時數值評分（NRS）≥4和NRS≥7的參與者中，Livdelzi在第12個月時導致瘙癢幾乎解決（NRS爲0或1）的參與者分別爲26.5%和18.8%，而安慰劑組爲0%。
Price Action: GILD stock is down 3.48% at $88.90 at last check Friday.
股價走勢：截至上週五最後查詢，GILD股價下跌3.48%，報88.90美元。
Photo via Shutterstock
圖片來自shutterstock
- Trump's Victory Spurs $50B Corporate Bond Surge As Tax Cut Optimism Drives Borrowing Costs To 25-Year Low
- 特朗普的勝利促使企業債券激增500億美元，因爲減稅樂觀情緒推動借貸成本降至25年來的最低點
譯文內容由第三人軟體翻譯。
