从NASH-FX临床试验结果程短的GR-MD-02没有改善肝脏硬度与炎症

StephenW

Results from the NASH-FX clinical trial involving GR-MD-02 show the drug met neither its primary endpoint of improving inflammation and fibrosis nor the secondary endpoint of improved liver stiffness with a short course of treatment, manufacturer Galectin Therapeutics said in a press release.

“Although there was no apparent improvement in the three non-invasive tests for assessment of liver fibrosis in this 4-month pilot trial, inhibition of galectin-3 with GR-MD-02 remains promising for treatment of [nonalcoholic steatohepatitis] fibrosis,” Stephen A. Harrison, MD, principal investigator of NASH-FX and medical director of Pinnacle Clinical Research in San Antonio, said in a conference call with reporters. “It is encouraging that there is an important clinical effect in moderate-to-severe psoriasis, suggesting the compound has activity in a human disease that can occur in association with NASH.”

According to Galectin, researchers assessed fibrosis using LiverMultiScan (Perspectum Diagnostics) and evaluated liver stiffness via magnetic resonance elastography and FibroScan (Echosens). Thirty patients were included in the study, 15 treated with GR-MD-02 and 15 received placebo. The endpoint was an adjustment of baseline mean value of corrected T1 value as determined by LiverMultiScan, according to Galectin.

“The NASH-FX trial was designed to follow up on limited data from a phase 1 study in NASH with advanced fibrosis, which suggested that FibroScan measurements may have improved with just four doses of drug,” Harrison said in the press release. “However, as we have witnessed in other liver fibrosis trials, the relatively short treatment duration of only 4 months assessed in the NASH-FX was inadequate to see an efficacy response.”

Through NASH-FX and an ongoing NASH-CX study, more than 1,600 doses of GR-MD-02 (Galectin Therapeutics) have been administered with no serious adverse effects. NASH-FX’s failure to meet its endpoints means researchers will use results from the year-long NASH-CX study in patients with NASH cirrhosis to advance GR-MD-02’s treatment potential, according to the release.

“It is critical that we complete the longer therapy, much larger NASH-CX trial,” Harrison said in the press conference.

Results from the NASH-CX trial are expected by December 2017. – by Janel Miller

Disclosure: Healio.com/Hepatology was unable to determine Harrison’s relevant financial disclosures at time of publication.

StephenW

从NASH-FX临床试验结果，涉及GR-MD-02表明该药物遇到既不其改善炎症和纤维化，也没有改善肝脏硬度与治疗的疗程短的次要终点的主要终点，厂家半乳糖凝集素治疗在一份新闻稿中说： 。

“虽然有三个非侵入性检查肝纤维化的评估没有明显的改善，这4个月的试点试验，半乳糖凝集素-3的抑制与GR-MD-02仍然看好治疗[非酒精性脂肪性肝炎]纤维化”斯蒂芬A.哈里森，MD，NASH-FX和在圣安东尼奥品尼高临床研究的医疗主任的首席研究员，在接受记者的电话会议上说。 “令人鼓舞的是，有中度至重度牛皮癣的一个重要的临床作用，提示该化合物在可能发生在NASH协会人类疾病的活动。”

据半乳糖凝集素，研究人员通过磁共振弹性和肝纤维（Echosens）使用LiverMultiScan（Perspectum诊断）和评估肝脏硬度评估纤维化。 30例患者纳入研究，15与GR-MD-02和15处理接受安慰剂。终点是由LiverMultiScan决定，根据基线半乳糖凝集素的调整意味着修正值T1的值。

“纳什-FX试验的目的是从晚期肝纤维化的NASH第一阶段的研究，这表明，肝纤维测量可能只用四个剂量药物的改善有限的数据跟进，”哈里森在新闻发布会上说。 “然而，正如我们在其他肝纤维化试验的见证下，在NASH-FX评估的只有4个月的相对较短的治疗时间不足，无法看到疗效反应。”

通过NASH-FX和持续NASH-CX研究，1600多剂量GR-MD-02（半乳糖凝集素治疗）已服用，无严重不良反应。 NASH-FX未能履行其端点意味着研究人员将利用NASH患者肝硬化从长达一年的NASH-CX研究成果推进GR-MD-02的治疗潜力，根据发行。

“我们完成再治疗，更大的NASH-CX试验这是至关重要的，”哈里森在新闻发布会上说。

从NASH-CX试验结果是在2017年预计12月份 - 由哈内尔米勒

披露：Healio.com/Hepatology无法确定在发布时哈里森的相关财务披露。