A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-297 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD), and the Effect of Food on EDP-297 Pharmacokinetics in Healthy Subjects

This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.

开始日期2020-09-08

申办/合作机构

Enanta Pharmaceuticals, Inc.

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100 项与 EDP-297 相关的临床结果

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100 项与 EDP-297 相关的转化医学

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100 项与 EDP-297 相关的专利（医药）

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项与 EDP-297 相关的文献（医药）

2023-02-01·Clinical and Translational Science

EDP‐297: A novel, farnesoid X receptor agonist—Results of a phase I study in healthy subjects

Article

作者: Oosterhaven, Jart ; Luo, Ed ; van Marle, Sjoerd ; Marotta, Christine ; Ahmad, Alaa ; Adda, Nathalie

AbstractEDP‐297 is a farnesoid X receptor agonist under development for treating nonalcoholic steatohepatitis. The pharmacokinetic (PK), pharmacodynamic (PD), food effect, and safety were evaluated in a single ascending dose (SAD) and multiple ascending dose (MAD) phase I study. Healthy subjects received single EDP‐297 doses of 20–600 μg or once daily doses of 5–90 μg for 14 days. Safety, PKs, and PDs were assessed, including fibroblast growth factor 19 (FGF‐19) and 7‐α‐hydroxy‐4‐cholesten‐3‐one (C4). Among 82 subjects, EDP‐297 was generally well‐tolerated. Pruritus was observed in four subjects in the SAD phase and seven subjects in the MAD phase; four severe cases occurred at 90 μg in the MAD phase, including one that led to drug discontinuation. A grade 2 elevation in alanine aminotransferase occurred with 90 μg. Mean lipid values remained within normal range. Plasma exposures of EDP‐297 increased with SADs and MADs, with mean half‐life following multiple doses of 9–12.5 h. No food effect was observed. Mean FGF‐19 increased and C4 decreased up to 95% and 92%, respectively. EDP‐297 was generally well‐tolerated up to 60 μg MAD, with linear PKs suitable for once daily oral dosing, target engagement, and no food effect.

项与 EDP-297 相关的新闻（医药）

2022-06-08

·BioSpace

Enanta Pharmaceuticals Announces Data Presentations at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022

June 8, 2022 11:00 UTC WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that data from Enanta’s internal development program portfolio for hepatitis B virus (HBV) and its out-licensing program portfolio for non-alcoholic steatohepatitis (NASH) have been accepted for poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress 2022 being held June 22 – 26, 2022 in London, United Kingdom. Clinical data presented from the company’s internal development portfolio will include poster presentations highlighting findings from both viremic and nuc-suppressed HBV patients from Phase 1b studies of EDP-514, Enanta’s HBV core inhibitor. As part of its out-licensing program portfolio, Enanta will present a late-breaker poster of preclinical data showing hepatoprotection provided by a novel inhibitor of the HSD17B13 enzyme. The company will also present clinical results from its Phase 1 study of EDP-297, a novel, highly potent Farnesoid X receptor agonist designed for the treatment of non-alcoholic steatohepatitis. Internal Development Programs June 25, 2022, 09:00 – 18:00 BST SAT390: “EDP-514, a Novel Pangenotypic Class II Hepatitis B Virus Core Inhibitor: Final Results of a 28-Day Phase 1b Study in Nuc-Suppressed Chronic Hepatitis B Patients” Session: Viral Hepatitis B/D: therapy Presenter: Dr. Jordan Feld SAT393: “EDP-514, a Potent Pangenotypic Class II Hepatitis B Virus Core Inhibitor Demonstrates Significant HBV DNA and HBV RNA Reductions in a Phase 1b Study in Viremic, Chronic Hepatitis B Patients” Session: Viral Hepatitis B/D: therapy Presenter: Dr. Man-Fung Yuen Out-Licensing Programs June 25, 2022, 09:00 – 18:00 BST SAT109: “EDP-297: A Novel, Highly Potent, Farnesoid X Receptor Agonist. Results of a Phase 1 Study in Healthy Adults” Session: NAFLD: Therapy Presenter: Dr. Alaa Ahmad SAT177: “Pharmacologic Inhibition of HSD17B13 is Hepatoprotective in Mouse Models of Liver Injury” Session: Molecular and Cell Biology Presenter: Dr. Manuel Roqueta-Rivera The full scientific program for The International Liver Congress 2022, as well as the abstracts, can be found at . Further details will be available at the time of these presentations. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta’s research and development programs include clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV). Enanta’s research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic HCV infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit for more information.

小分子药物

2021-11-19

·Endpoints

Safety threat forces Enanta to scrap HBV trials — sending discovery team back to drawing board

A Massachusetts biotech will discontinue the development of its oral drug intended to treat patients suffering from chronic hepatitis B infections, the company said Thursday. Enanta Pharmaceuticals will no longer develop EDP-721. The news comes after safety signals were seen in healthy participants in a Phase I trial after they were administered the drug, and despite a clean safety profile demonstrated in preclinical trials. “Patient safety is our top priority, and we have therefore decided to discontinue further development of this compound,” said CEO Jay Luly. “We are committed to developing a functional cure for chronic hepatitis B patients, and remain confident in EDP-514, our HBV core inhibitor, which has demonstrated safe and robust antiviral activity in Phase 1b studies of viremic and NUC-suppressed patients with chronic HBV infection.” Enanta will advance its HBV program after further discovery efforts, Luly said. Hepatitis B is a viral infection that can attack the liver and cause both acute and chronic disease. It is most typically transmitted from mother to child in birth and delivery, as well as through other bodily fluids. An estimated 290 million people around the world have chronic HBV infections. Enanta is currently developing candidates to target respiratory syncytial virus, HBV and Covid-19. Its R&D efforts are funded through royalties from its hepatitis C virus products developed alongside AbbVie. Early last month, the company offloaded in-house development of its two FXR agonist NASH drugs, EDP-305 and follow-up candidate EDP-297, and said it would move to an out-licensing strategy after the early data showed little chance of solo success for either drug. Baird analyst Brian Skorney called the decision “incrementally positive,” remarking that Enanta could focus its work on efforts in Covid-19, RSV and HBV, while avoiding the long, winding road that comes along with NASH. But the latest setback will send the company back to the drawing board again. “We believe that the multiple mechanisms in development for NASH today, which reflect the complex pathophysiology of this disease, make it likely that a combination approach with FXR agonists will ultimately provide the optimal treatment regimen for patients,” Luly said in a statement. Enanta did announce positive data from its Phase Ib study of EDP-514 to treat NUC-suppressed chronic HBV patients. The trial showed that it was safe and well-tolerated, and the data support a once-daily oral dosing regimen.

2021-10-04

·BioSpace

Enanta Axes Two Farnesoid X Receptor Agonists for NASH

Shares of Enanta Pharmaceuticals are falling this morning after the company announced plans to scrap the development of its two clinical stage farnesoid X receptor (FXR) agonists being developed as a potential treatment for non-alcoholic steatohepatitis (NASH). Instead of continuing to develop the two different assets, EDP-305 and EDP-297, the company intends to seek an out-licensing deal that will further advance the research it began. Enanta plans to maintain its focus and resources on therapies aimed at hepatitis B virus and infectious respiratory diseases, including respiratory syncytial virus (RSV) and SARS-CoV-2, the virus that causes COVID-19. This morning, the Watertown, Mass.-based company said it came to its decision following a preplanned examination from a Phase IIb study of EDP-305, a monotherapy FXR agonist treatment. Although its clinical data determined that a 1 mg dose of the experimental drug provided the best safety and efficacy results, the company decided to scrap the development of the program. And that likely means that the data was not strong enough for Enanta to continue to develop the asset on its own. Jay R. Luly, president and chief executive officer of Enanta Pharmaceuticals, believes that the company's FXR agonists will likely do well as part of a combination treatment for NASH, a growing health concern that currently affects about 16 million people in the United States. EDP-305 was being developed as a monotherapy and EDP-297 was being developed as a follow-on treatment. Luly said both of the FXR agonists are “well-positioned to be an important component of a combination therapy to bring a much-needed treatment to patients with NASH.” The treatment, however, will have to be developed by another company. Luly pointed to the complex pathophysiology of NASH and suggested that some other companies developing therapies for NASH could benefit from Enanta’s research. Enanta certainly isn’t the first company to fail to hit the mark in the NASH space. Nor is it the first company assessing an FXR agonist. Last year, Intercept Pharmaceuticals received a Complete Response Letter from the U.S. Food and Drug Administration for its experimental NASH treatment, obeticholic acid. Multiple companies have also struggled to achieve clinical success. NGM Biopharmaceuticals failed to hit the mark in a Phase IIb study assessing aldafermin, an engineered analog of the human hormone FGF19, earlier this year, while GENFIT ended its development of elafibranor for NASH following a trial failure last year. There are more than 200 different treatments in development for NASH, but none of them have succeeded in the clinic so far. NASH is a progressive liver disease caused by excessive fat accumulation in the liver, inducing chronic inflammation. That inflammation then results in progressive fibrosis, leading to cirrhosis, eventual liver failure, cancer, and death. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH. The disease is projected to become the leading cause of liver transplants in the United States.

100 项与 EDP-297 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
非酒精性脂肪性肝炎	临床1期	荷兰	Enanta Pharmaceuticals, Inc.	2020-09-08

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04559126 (Pubmed) 人工标引	临床1期	-	82	EDP-297	(淵壓積醖鑰網夢廠遞積) = 壓鏇鹹夢鹹膚憲淵憲鹽廠蓋鹽繭淵窪衊夢築鹹 (鑰簾積衊顧膚衊餘糧繭 ) 更多	积极	2022-11-11
EASL2020	N/A	非酒精性脂肪性肝炎 \| 肝损伤	-	EDP-297	壓鬱廠鏇網夢積醖選築(繭獵獵糧網願壓築齋醖) = 鹹選蓋觸觸鹹簾淵繭選餘廠選衊醖範選鹹簾鬱 (鏇餘襯構網衊餘醖夢夢 )	-	2020-08-27