Organovo Presents Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver Meeting
Organovo Presents Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver Meeting
Study subjects receiving FXR314 achieved statistically significant reduction in liver fat content from baseline, with LS mean percent reduction at end of treatment of 22.8% (p=0.0010) with 3 mg and 17.5% (p=0.0267) with 6 mg doses of FXR314 compared to 6.1% in the placebo group. The proportion of subjects with >30% magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) reduction was 29.2% (p=0.0023) and 32.2% (p=0.0020) for 3 mg and 6 mg FXR314, respectively, compared to 9.5% with placebo. Investigators observed improvements in hepatocellular damage and liver function based on serological measures, with no evidence of worsening of liver fibrosis.SAN DIEGO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces that its oral presentation of its lead clinical stage drug FXR314 by Dr. Eric Lawitz of the Texas Liver Institute and the University of Texas Health San Antonio was featured at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). The meeting was held November 15-19, 2024 in San Diego, California.
圣地亚哥，2024年11月20日（GLOBE NEWSWIRE）——专注于开发包括溃疡性结肠炎在内的炎症性肠病（IBD）新疗法的临床阶段生物技术公司Organovo Holdings, Inc.（纳斯达克股票代码：ONVO）今天宣布，德克萨斯肝脏研究所和德克萨斯大学圣安东尼奥分校健康分校的埃里克·拉维茨博士对其主要临床阶段药物 FXR314 的口头陈述已在肝脏会议上发表，由美国肝脏疾病研究协会（AASLD）撰写。该会议于2024年11月15日至19日在加利福尼亚州圣地亚哥举行。
The presentation entitled "Pharmacokinetics, Safety and Efficacy of the Novel Non-bile Acid FXR Agonist FXR314 in Patients with Metabolic Dysfunction-Associated Steatohepatitis: Results from a Phase 2 Study" was presented on Sunday, November 17 in the MASLD and MASH – New therapies session.
题为 “新型非胆酸FXR激动剂 FXR314 在代谢功能障碍相关性脂肪肝患者中的药代动力学、安全性和有效性：2期研究结果” 的演讲于11月17日星期日在MASLD和MASH — 新疗法会议上发表。
Dr. Lawitz shared the complete details of the 16-week, randomized, placebo-controlled, multi-center Phase 2 study of FXR314 in MASH patients. A total of 214 patients were randomized in a 1:1:1 ratio to either 3 mg or 6 mg of FXR314, or placebo. Study results demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo, and a safety profile demonstrating significantly lower pruritus rates than seen with other FXR agonists.
Lawitz 博士分享了针对 MASH 患者的 FXR314 为期 16 周、随机、安慰剂对照、多中心 2 期研究的完整细节。共有 214 名患者以 1:1:1 的比例随机分配为 3 mg 或 6 mg 的 FXR314 或安慰剂。研究结果表明，与安慰剂相比，接受 FXR314 的患者的肝脂含量比基线显著降低，而且安全性分析表明，与使用其他 FXR 激动剂相比，瘙痒率明显降低。
Study subjects receiving FXR314 achieved statistically significant reduction in liver fat content from baseline, with LS mean percent reduction at end of treatment of 22.8% (p=0.0010) with 3 mg and 17.5% (p=0.0267) with 6 mg doses of FXR314 compared to 6.1% in the placebo group. The proportion of subjects with >30% magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) reduction was 29.2% (p=0.0023) and 32.2% (p=0.0020) for 3 mg and 6 mg FXR314, respectively, compared to 9.5% with placebo. Investigators observed improvements in hepatocellular damage and liver function based on serological measures, with no evidence of worsening of liver fibrosis.
接受 FXR314 的研究受试者的肝脏脂肪含量比基线有了统计学上的显著降低，3 mg 治疗结束时 LS 的平均百分比降低了 22.8%（p=0.0010），服用 6 mg 剂量 FXR314 时的 LS 平均减少百分比为 17.5%（p=0.0267），而安慰剂组的这一比例为 6.1%。对于3 mg和6 mg FXR314，磁共振成像衍生质子密度脂肪分数（MRI-PDFF）降低超过30％的受试者比例分别为29.2％（p=0.0023）和32.2％（p=0.0020），而安慰剂的受试者比例为9.5％。根据血清学测量，研究人员观察到肝细胞损伤和肝功能有所改善，没有证据表明肝纤维化恶化。
FXR314 was also found to be safe and well tolerated. Treatment-emergent adverse events were mostly mild to moderate in severity, with incidence comparable between FXR314 3 mg, 6 mg, and placebo. Drug-related treatment discontinuation was low in frequency and similar across groups. FXR314 did not demonstrate significant adverse events typical of the FXR class, including pruritus (3 mg 2.8%, 6 mg 4.2% and placebo 2.8%) and LDL-C levels (change from baseline of 1.5%, 4.5% and -3.6% for 3mg, 6mg, and placebo groups respectively).
还发现 FXR314 是安全的，耐受性良好。紧急治疗不良事件的严重程度大多为轻度至中度，发病率在 FXR314 3 mg、6 mg 和安慰剂之间。与药物相关的中断治疗的频率很低，各组之间相似。FXR314 未表现出 FXR 类典型的重大不良事件，包括瘙痒（3 mg 2.8%、6 mg 4.2% 和安慰剂 2.8%）和低密度脂蛋白 C 水平（与 3mg、6mg 和安慰剂组分别为 1.5%、4.5% 和 -3.6% 的基线相比变化）。
| FXR314 3 mg | FXR314 6 mg | Placebo | |
| Liver fat reduction (LS mean reduction from baseline, SE) |
22.8 + 3.6% p=0.0010 |
17.5 + 3.7% p=0.0267 |
6.1 + 3.5% |
| Subjects with >30% MRI-PDFF reduction | 29.2% p=0.0023 |
32.2% p=0.0020 |
9.5% |
| Pruritus | 2.8% | 4.2% | 2.8% |
| Pruritus-related treatment discontinuation | 0% | 0% | 0% |
| FXR314 3 毫克 | FXR314 6 毫克 | 安慰剂 | |
| 减少肝脏脂肪 （LS 平均比基线降低，SE） |
22.8 + 3.6% p=0.0010 |
17.5 + 3.7% p=0.0267 |
6.1 + 3.5% |
| MRI-PDFF 减幅超过 30% 的受试者 | 29.2% p=0.0023 |
32.2% p=0.0020 |
9.5% |
| 瘙痒 | 2.8% | 4.2% | 2.8% |
| 与瘙痒相关的治疗中断 | 0% | 0% | 0% |
"These results are encouraging as we saw FXR314 treatment resulting in liver fat reduction but did not demonstrate the expected toxicities of this class," stated Dr. Lawitz. "Due to this unique profile, I am excited about the prospects of further evaluating FXR314 for the treatment of MASH. The intestinal activating specificity is intriguing."
拉维茨博士说：“这些结果令人鼓舞，因为我们看到 FXR314 治疗可以减少肝脏脂肪，但并未证明该类别的预期毒性。”“由于这种独特的概况，我对进一步评估用于治疗 MASH 的 FXR314 的前景感到兴奋。肠道激活特异性很有趣。”
About Organovo
Organovo is a clinical stage biotechnology company that is developing drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company's lead molecule, FXR314, is on the path for Phase 2 investigation in inflammatory bowel disease and has potential application in metabolic liver disease and oncology. The company has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease. For more information visit Organovo's website at .
关于 Organovo
Organovo是一家临床阶段的生物技术公司，正在开发经证明对三维（3D）人体组织有效的药物，作为药物开发的候选药物。该公司的主导分子 FXR314 正在进行炎症性肠病的二期研究，并有可能应用于代谢性肝病和肿瘤学。该公司拥有专有技术，用于构建 3D 人体组织，模仿天然人体组织组成、结构、功能和疾病的关键方面。欲了解更多信息，请访问Organovo的网站，网址为。
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Source: Organovo, Inc.
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