Gilead's Recently Acquired Liver Disease Candidate Shows Improvements In Disease Progression And Associated Itch
Gilead's Recently Acquired Liver Disease Candidate Shows Improvements In Disease Progression And Associated Itch
Saturday, Gilead Sciences Inc (NASDAQ:GILD), following the recent acquisition of CymaBay Therapeutics Inc, announced interim results from the ongoing ASSURE study.
繼最近收購CymaBay Therapeutics Inc之後，吉利德科學公司（納斯達克股票代碼：GILD）週六公佈了正在進行的ASSURE研究的中期結果。
The ASSURE study is an open-label study to evaluate the long-term safety and tolerability of seladelpar in people with primary biliary cholangitis (PBC) who have already participated in other PBC clinical trials of seladelpar. The study is currently enrolling up to 500 people.
ASSURE研究是一項開放標籤研究，旨在評估已參與其他PBC塞拉德帕臨床試驗的原發性膽源性膽管炎（PBC）患者的塞拉德帕的長期安全性和耐受性。該研究目前招收多達500人。
Also Read: Gilead's Aggressive Push Beyond HIV Treatments – Plans To Increase Cancer-Focused CAR-T Treatment Production.
另請閱讀： 吉利德積極推動HIV治療以外的努力——計劃增加以癌症爲重點的CAR-T治療產量。
The study demonstrated that the treatment with seladelpar led to improvements in markers of cholestasis and reduced inflammation.
該研究表明，使用seladelpar治療可改善膽汁淤積標誌物並減少炎症。
Additional findings demonstrate that seladelpar can help reduce pruritus (itch) in primary biliary cholangitis patients.
其他發現表明，seladelpar可以幫助減少原發性膽源性膽管炎患者的瘙癢（瘙癢）。
70% of the 148 patients who completed 12 months of treatment achieved the clinically meaningful composite response endpoint.
在完成12個月治療的148名患者中，有70％達到了具有臨床意義的複合反應終點。
Among those receiving seladelpar, 37% experienced alkaline phosphatase (ALP) normalization, with a mean ALP change from baseline of -44% (-144.4 U/L).
在接受seladelpar治療的人群中，有37％的人經歷了鹼性磷酸酶（ALP）正常化，與基線相比的平均ALP變化爲-44％（-144.4 U/L）。
Of the 20 patients who completed 24 months of treatment, 70% achieved the composite response endpoint, and 25% experienced ALP normalization.
在完成24個月治療的20名患者中，70％達到了複合反應終點，25％的患者出現了ALP正常化。
Seladelpar also reduced other important biomarkers of liver injury, including TB, gamma-glutamyl transferase (GGT), and alanine aminotransferase (ALT) levels by 9%, 36%, and 25% from baseline, respectively.
Seladelpar還將肝損傷的其他重要生物標誌物，包括結核病、γ-谷氨酰轉移酶（GGT）和丙氨酸氨基轉移酶（ALT）水平分別比基線降低了9％、36％和25％。
There were no treatment-related serious adverse events in the study.
該研究中沒有與治療相關的嚴重不良事件。
Seladelpar was generally well tolerated, with discontinuation due to adverse events occurring in 4.6% of patients.
Seladelpar的耐受性總體良好，4.6％的患者因不良事件而停藥。
In the 60 patients with moderate-to-severe pruritus, a rapid improvement in pruritus was observed at Month 1.
在60名中度至重度瘙癢症患者中，在第1個月觀察到瘙癢症狀迅速改善。
By Month 6 the patients reported a mean reduction of 3.5 points, and this impact was sustained through Month 12.
到第6個月，患者報告的平均下降了3.5個百分點，這種影響一直持續到第12個月。
A New Drug Application for seladelpar for PBC has been accepted for priority review by the FDA, with an anticipated decision in August 2024.
美國食品藥品管理局已接受用於PBC的seladelpar新藥申請進行優先審查，預計將在2024年8月做出決定。
Price Action: GILD shares are down 0.44% at $67.42 at last check Monday.
價格走勢：週一最後一次檢查時，GILD股價下跌0.44％，至67.42美元。
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照片來自 Shutterstock