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主导药物显示MASH患者的纤维化改善,Akero股价上涨

Akero stock jumps as lead drug shows added fibrosis improvement in MASH patients

seekingalpha 2024-03-04 20:38 翻译由动脉网AI生成,点击反馈

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Benito Vega/iStock via Getty Images Shares of Akero Therapeutics (NASDAQ:AKRO) jumped around 70% in early trading on Monday after a Phase 2 study of its lead drug, efruxifermin (EFX), showed statistically significant histological improvements in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH).

Benito Vega/iStock通过Getty Images周一早盘,Akero Therapeutics(NASDAQ:AKRO)的股价上涨约70%,此前对其主要药物efruxifermin(EFX)进行的第二阶段研究显示,肝硬化前代谢功能障碍相关脂肪性肝炎(MASH)患者的组织学改善具有统计学意义。

MASH is a serious form of metabolic-associated steatotic liver disease that can progress to cirrhosis, liver failure, cancer and eventually death. There are no approved treatments for the condition yet. The Phase 2b HARMONY study is testing Akero’s (AKRO) efruxifermin in biopsy-confirmed adult MASH patients with fibrosis stage 2 or 3.

MASH是一种严重的代谢相关脂肪变性肝病,可发展为肝硬化,肝衰竭,癌症并最终死亡。目前还没有批准的治疗方法。2b期和谐研究正在活检证实的2或3期纤维化成人MASH患者中测试Akero(AKRO)efruxifermin。

The study previously met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose groups, compared to 20% for the placebo arm. At week 96, patients biopsies showed that efruxifermin helped reduce scarring in liver by at least one stage in 75% of patients who took 50mg EFX, and in 46% of patients who took 28mg EFX, compared to 24% for placebo.

该研究先前达到了纤维化≥1期改善的主要终点,50mg EFX(41%)和28mg EFX(39%)剂量组治疗24周后MASH没有恶化,而安慰剂组为20%。在第96周,患者活检显示,服用50mg EFX的患者中有75%的患者和服用28mg EFX的患者中,efruxifermin有助于减少肝脏瘢痕形成至少一个阶段,而安慰剂组为24%。

Both dose groups also showed ≥2 stage improvement in fibrosis without worsening of MASH, more than 10-fold the placebo rate (3%). Analysis of the evolution of responses between weeks 24 and 96 indicated not only broader fibrosis improvement without worsening of MASH but also sustained response, particularly at the higher dose of efruxifermin.

两个剂量组也显示纤维化改善≥2阶段,而MASH没有恶化,是安慰剂率(3%)的10倍以上。对第24周和第96周之间反应演变的分析表明,不仅纤维化改善更广泛,而MASH没有恶化,而且持续反应,特别是在较高剂量的efruxifermin下。

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Furthermore, the drug was reported to be generally well-tolerated, and there were no deaths. More on Akero Therapeutics Eli Lilly hurts NASH drug developers after mid-stage win for obesity therapy Seeking Alpha’s Quant Rating on Akero Therapeutics Historical earnings data for Akero Therapeutics Financial information for Akero Therapeutics .

此外,据报道该药物总体耐受性良好,没有死亡。关于Akero Therapeutics的更多信息Eli Lilly在肥胖治疗中期获胜后伤害了NASH药物开发人员,寻求Akero Therapeutics的Alpha定量评级Akero Therapeutics的历史收益数据Akero Therapeutics的财务信息。

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