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.
聖地亞哥，2024年11月20日（GLOBE NEWSWIRE）——專注於開發包括潰瘍性結腸炎在內的炎症性腸病（IBD）新療法的臨床階段生物技術公司Organovo Holdings, Inc.（納斯達克股票代碼：ONVO）今天宣佈，德克薩斯肝臟研究所和德克薩斯大學聖安東尼奧分校健康分校的埃裏克·拉維茨博士對其主要臨床階段藥物 FXR314 的口頭陳述已在肝臟會議上發表，由美國肝臟疾病研究協會（AASLD）撰寫。該會議於2024年11月15日至19日在加利福尼亞州聖地亞哥舉行。
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.
題爲 「新型非膽酸FXR激動劑 FXR314 在代謝功能障礙相關性脂肪肝患者中的藥代動力學、安全性和有效性：2期研究結果」 的演講於11月17日星期日在MASLD和MASH — 新療法會議上發表。
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 博士分享了針對 MASH 患者的 FXR314 爲期 16 周、隨機、安慰劑對照、多中心 2 期研究的完整細節。共有 214 名患者以 1:1:1 的比例隨機分配爲 3 mg 或 6 mg 的 FXR314 或安慰劑。研究結果表明，與安慰劑相比，接受 FXR314 的患者的肝脂含量比基線顯著降低，而且安全性分析表明，與使用其他 FXR 激動劑相比，瘙癢率明顯降低。
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 的研究受試者的肝臟脂肪含量比基線有了統計學上的顯著降低，3 mg 治療結束時 LS 的平均百分比降低了 22.8%（p=0.0010），服用 6 mg 劑量 FXR314 時的 LS 平均減少百分比爲 17.5%（p=0.0267），而安慰劑組的這一比例爲 6.1%。對於3 mg和6 mg FXR314，磁共振成像衍生質子密度脂肪分數（MRI-PDFF）降低超過30％的受試者比例分別爲29.2％（p=0.0023）和32.2％（p=0.0020），而安慰劑的受試者比例爲9.5％。根據血清學測量，研究人員觀察到肝細胞損傷和肝功能有所改善，沒有證據表明肝纖維化惡化。
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).
還發現 FXR314 是安全的，耐受性良好。緊急治療不良事件的嚴重程度大多爲輕度至中度，發病率在 FXR314 3 mg、6 mg 和安慰劑之間。與藥物相關的中斷治療的頻率很低，各組之間相似。FXR314 未表現出 FXR 類典型的重大不良事件，包括瘙癢（3 mg 2.8%、6 mg 4.2% 和安慰劑 2.8%）和低密度脂蛋白 C 水平（與 3mg、6mg 和安慰劑組分別爲 1.5%、4.5% 和 -3.6% 的基線相比變化）。
| 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 | 安慰劑 | |
| 減少肝臟脂肪 （LS 平均比基線降低，SE） |
22.8 + 3.6% p=0.0010 |
17.5 + 3.7% p=0.0267 |
6.1 + 3.5% |
| MRI-PDFF 減幅超過 30% 的受試者 | 29.2% p=0.0023 |
32.2% p=0.0020 |
9.5% |
| 瘙癢 | 2.8% | 4.2% | 2.8% |
| 與瘙癢相關的治療中斷 | 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."
拉維茨博士說：「這些結果令人鼓舞，因爲我們看到 FXR314 治療可以減少肝臟脂肪，但並未證明該類別的預期毒性。」「由於這種獨特的概況，我對進一步評估用於治療 MASH 的 FXR314 的前景感到興奮。腸道激活特異性很有趣。」
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 .
關於 Organovo
Organovo是一家臨床階段的生物技術公司，正在開發經證明對三維（3D）人體組織有效的藥物，作爲藥物開發的候選藥物。該公司的主導分子 FXR314 正在進行炎症性腸病的二期研究，並有可能應用於代謝性肝病和腫瘤學。該公司擁有專有技術，用於構建 3D 人體組織，模仿天然人體組織組成、結構、功能和疾病的關鍵方面。欲了解更多信息，請訪問Organovo的網站，網址爲。
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