吉利德宣布NASH纤维化3期试验的阴性结果

StephenW

Gilead announces negative results from phase 3 trial for NASH fibrosis
February 12, 2019

Results from the STELLAR-4 phase 3 study showed that selonsertib did not meet the pre-specified 48-week endpoint of histologic improvement by 1 or more stage in fibrosis without worsening of nonalcoholic steatohepatitis, according to a press release.

“While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments,” John McHutchison, AO, MD, chief scientific officer and head of research and development at Gilead, said in the release. “Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases.”


The study comprised 877 patients with NASH and compensated cirrhosis. At study end, 14.4% of those who received 18 mg of selonsertib and 12.5% of those who received 6 mg of selonsertib achieved an improvement in fibrosis by 1 or more stage. Selonsertib was generally well-tolerated and safety results were consistent with prior studies.

Gilead reports that further in-depth analysis of the findings is ongoing, and the data will be submitted to an upcoming scientific conference.

“Data from this large study of patients with compensated cirrhosis due to NASH, including the extensive set of biomarkers collected, will further advance our understanding of the disease and inform our broader NASH development programs,” McHutchinson said in the release.

Reference: www.gilead.com

StephenW

吉利德宣布NASH纤维化3期试验的阴性结果
2019年2月12日

根据一份新闻稿，STELLAR-4 3期研究的结果显示，selonsertib未达到预先指定的48周组织学改善终点，纤维化1个或更多阶段，而非酒精性脂肪性肝炎恶化。

“虽然我们对STELLAR-4研究没有达到其主要终点感到失望，但我们仍然致力于为因NASH引起晚期纤维化的患者推进治疗，其中对有效且耐受性良好的治疗存在显着的未满足需求，”John Gilead的首席科学官兼研发主管，医学博士McHutchison在发布会上说。 “吉利德在解决肝病领域的重大挑战方面有着长期的承诺和良好的记录。”


该研究包括877名患有NASH和代偿性肝硬化的患者。在研究结束时，接受18mg selonsertib的患者中有14.4％和接受6mg selonsertib治疗的患者中有12.5％的患者纤维化改善了1个或更多阶段。 Selonsertib通常具有良好的耐受性，安全性结果与之前的研究一致。

吉利德报告说，正在对这些调查结果进行进一步的深入分析，这些数据将提交给即将召开的科学会议。

“这项针对由于NASH引起的代偿性肝硬化患者的大型研究的数据，包括收集的大量生物标志物，将进一步推进我们对该疾病的认识，并为我们更广泛的NASH发展计划提供信息，”McHutchinson在发布中说。

参考：www.gilead.com