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
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 (環球新聞) -- 專注於發展炎症性腸道疾病(IBD)包括潰瘍性結腸炎的新型治療方法的臨床階段生物技術公司Organovo控股公司(納斯達克:ONVO)今日宣佈,德克薩斯州肝臟研究所和德克薩斯大學聖安東尼奧健康中心的Eric Lawitz博士發表了其領先的臨床階段藥物FXR314的口頭報告,該報告在美國肝病研究協會(AASLD)主辦的肝臟會議上特色板塊亮相。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.
標題爲"新型非膽汁酸FXR激動劑FXR314在代謝功能紊亂相關脂肪肝患者中的藥代動力學、安全性和療效:來自2期研究的結果"的演示是在星期日,11月17日在MASLD和MASH - 新療法會議上進行的。
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FXR314在MASH患者中進行的爲期16周的隨機、安慰劑對照、多中心2期研究的完整細節。共有214名患者按1:1:1的比例隨機分配到3毫克或6毫克的FXR314或安慰劑。研究結果表明,接受FXR314治療的患者與安慰劑組相比,肝脂含量從基線顯著減少,並且安全性評估顯示與其他FXR激動劑相比明顯較低的搔癢發生率。
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治療的研究對象在治療結束時相對於基線實現了肝脂含量的顯著減少,3毫克組爲22.8%(p=0.0010),6毫克組爲17.5%(p=0.0267),而安慰劑組爲6.1%。通過核磁共振成像獲得的脂肪分數(MRI-PDFF),肝脂減少30%以上的患者比例分別爲29.2%(p=0.0023)和32.2%(p=0.0020),而安慰劑組爲9.5%。研究人員觀察到基於血清學指標的肝細胞損傷和肝功能改喼,且沒有肝纖維化惡化的證據。
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).
FXR314也被發現安全且耐受良好。治療相關的不良事件大多數是輕度至中度的,發生率在FXR314 3毫克、6毫克和安慰劑組之間相當。與組間類似,藥物相關的治療中止頻率很低。FXR314未表現出FXR類典型的顯著不良事件,包括瘙癢(3毫克2.8%,6毫克4.2%和安慰劑2.8%)和LDL-C水平(基線變化分別爲3毫克、6毫克和安慰劑組的1.5%、4.5%和-3.6%)。
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 | |
肝脂減少 (LS代表相對基線的減少,標準誤) |
22.8 + 3.6% p=0.0010 |
17.5 + 3.7% p=0.0267 |
6.1 + 3.5% |
MRI-PDFF減少>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."
這些結果令人鼓舞,因爲我們看到FXR314治療導致肝脂肪減少,但並沒有展示出這一類藥物的預期毒性,Lawitz博士說:"由於這種獨特的特性,我對進一步評估FXR314用於治療MASH的前景感到興奮。腸道激活的特異性很有趣。"
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是一家處於臨床階段的生物技術公司,正在開發經證實在三維(3D)人體組織中有效的藥物作爲候選藥物開發。該公司的主導分子FXR314正在走向第2階段研究,用於炎症性腸病,並且在代謝性肝病和腫瘤學中具有潛在應用。該公司擁有專有技術,用於構建模仿人體組織關鍵方面的3D人體組織的組成、結構、功能和疾病。更多信息請訪問Organovo的網站。
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Source: Organovo, Inc.
來源:Organovo,Inc。