A Phase 2b Randomized, Double Blind, Placebo-Controlled, Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects with Liver-Biopsy Proven Non-Alcoholic Steatohepatitis (NASH) (ARGON-2) - ARGON-2

Start Date19 Aug 2020

Sponsor / Collaborator

Enanta Pharmaceuticals, Inc.

EUCTR2019-003876-38-GB / Unknown statusPhase 2

Start Date17 Jun 2020

Sponsor / Collaborator

Enanta Pharmaceuticals, Inc.

NCT04378010 / TerminatedPhase 2

A Phase 2b Randomized, Double-Blind, Placebo-controlled, Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects With Liver Biopsy Proven Non-alcoholic Steatohepatitis (NASH) (ARGON-2)

A randomized, double-blind study to assess the safety and efficacy of EDP-305 in subjects with liver-biopsy proven Non-Alcoholic Steatohepatitis (NASH)

Start Date27 Jan 2020

Sponsor / Collaborator

Enanta Pharmaceuticals, Inc.

100 Clinical Results associated with EDP-305

100 Translational Medicine associated with EDP-305

100 Patents (Medical) associated with EDP-305

Literatures (Medical) associated with EDP-305

01 Jan 2024·Diabetes & metabolic syndrome

Characteristics of contemporary drug clinical trials regarding the treatment of non-alcoholic steatohepatitis

Review

Author: Zhao, Junzhe ; Tasnim, Farah ; Zhang, Lan ; Yu, Hanry ; Zhao, Shanshan ; Venkat, Kartik Mitra ; Kota, Vishnu Goutham

BACKGROUND:

Non-alcoholic steatohepatitis (NASH), a chronic liver disease, has no United States Food and Drug Administration (FDA) approved drugs for treatment.

OBJECTIVES:

To examine fundamental characteristics of drug clinical trials for NASH treatment on the global clinical trials registry platform.

METHODS:

Cross-sectional analysis of clinical trials with NASH as medical condition that are registered on ClinicalTrials.gov. Relevant trial entries registered before and on October 7th, 2022, were downloaded, deduplicated, and reviewed. NCT numbers, titles, locations, funder types, statuses, durations, study designs, subject information, conditions, interventions, outcome measures were extracted and analyzed.

RESULTS:

Overall, 268 drug clinical trials were included in this study. Majority of the trials are conducted in United States (42.2 %). Most of the trials are funded by industry (67.9 %). The earliest initiated trials date back to 2001. Most trials are phase 2 (56.3 %), randomized (84.0 %), parallel assignment (78.7 %), and quadruple blind (40.3 %). The most concerned combined medical conditions are non-alcoholic fatty liver disease (NAFLD, 20.9 %). The most involved mechanisms of action drug categories are farnesoid X receptor (FXR) agonists and peroxisome proliferator-activated receptor (PPAR) agonists, with the most tested drugs being the FXR agonist EDP-305 and the Glucagon-like peptide-1 (GLP-1) agonist semaglutide.

CONCLUSION:

Old drugs are further repurposed for testing in NASH treatment, novel drugs are developed to try to cure NASH. We expect that the drug clinical trials will accelerate the frontier of therapeutic development in NASH, bring an innovative and efficacious medication therapeutic approach to prevent the development and progression of NASH, or even reverse NASH.

01 Sep 2022·Clinical and translational science

Assessment of drug–drug interaction potential with EDP‐305, a farnesoid X receptor agonist, in healthy subjects

Article

Author: Adda, Nathalie ; Ahmad, Alaa

Abstract:

EDP‐305 is a farnesoid X receptor (FXR) agonist that selectively activates FXR and is a potential treatment for patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis. Results from preclinical studies indicate that CYP3A4 is the primary enzyme involved in EDP‐305 metabolism and that EDP‐305 has low potential to inhibit or induce cytochrome (CYP) isoenzymes and drug transporters. Four studies were conducted in healthy volunteers to evaluate the drug–drug interaction (DDI) potential of EDP‐305 co‐administered with drugs known to be substrates for drug metabolizing enzymes or transporters, and to assess the effect of inhibitors and inducers of CYP3A4 on EDP‐305. Results suggest caution when substrates of CYP3A4 are administered concomitantly with EDP‐305. A potential for increased exposure is apparent when CYP1A2 substrates with a narrow therapeutic index are administered with EDP‐305. In contrast, substrates of drug transporters can be administered concomitantly with EDP‐305 with a low potential for interactions. Coadministration of EDP‐305 and a combined OC had no relevant effects on plasma concentrations of the combined OC. Co‐administration of EDP‐305 with strong or moderate inhibitors and inducers of CYP3A4 is not recommended. These results indicate low overall likelihood of interaction of EDP‐305 and other substrates through CYP mediated interactions. The interaction potential of EDP‐305 with drug transporters was low and of unlikely clinical significance. The EDP‐305 DDI profile allows for convenient administration in patients with NASH and other patient populations with comorbidities, with minimal dose modification of concomitant medications.

01 Mar 2022·Journal of hepatologyQ1 · MEDICINE

EDP-305 in patients with NASH: A phase II double-blind placebo-controlled dose-ranging study

Q1 · MEDICINE

Article

Author: Kowdley, Kris V ; Goodwin, Bryan ; Lawitz, Eric ; Rinella, Mary E ; Adda, Nathalie ; Kayali, Zeid ; Ahmad, Alaa ; Desta, Taddese ; Sheikh, Aasim ; Denham, Douglas ; Elkhashab, Magdy ; Neuschwander-Tetri, Brent A ; Ratziu, Vlad ; DeGrauw, Jeffery

BACKGROUND & AIMS:

EDP-305 is an oral farnesoid X receptor (FXR) agonist under development for the treatment of non-alcoholic steatohepatitis (NASH). Herein, we aimed to assess the efficacy, safety and tolerability of EDP-305 in patients with fibrotic NASH.

METHODS:

In this double-blind phase II study, patients with fibrotic NASH (without cirrhosis), diagnosed by historical biopsy or phenotypically, were randomized to EDP-305 1 mg, EDP-305 2.5 mg, or placebo, for 12 weeks. The primary endpoint was mean change in alanine aminotransferase (ALT) from baseline to Week 12, and the key secondary endpoint was mean change in liver fat content from baseline to Week 12.

RESULTS:

Between January 2018 and July 2019, 134 patients were randomized and 132 were evaluated. At Week 12, the least squares mean reductions from baseline in ALT for patients receiving 2.5 mg EDP-305 and 1 mg EDP-305 were -27.9 U/L (95% CI 0.03 to 24.9; p = 0.049) and -21.7 U/L (-5.8 to 18.3: p = 0.304), respectively, compared to -15.4 U/L for those receiving placebo. Absolute liver fat reduction was -7.1% (2.0-7.5; p = 0.0009) with 2.5 mg EDP-305, -3.3% with EDP-305 1 mg, and -2.4% with placebo. The most common (≥5%) adverse events were pruritus, nausea, vomiting, diarrhea, headache, and dizziness. Pruritus occurred in 50.9%, 9.1%, and 4.2% of patients in the 2.5 mg, 1 mg, and placebo groups, respectively, and led to study drug discontinuation in 20.8% of patients in the 2.5 mg group and 1.8% in the 1 mg group.

CONCLUSIONS:

EDP-305 reduced ALT levels and liver fat content, providing support for a longer-term trial assessing histological endpoints in patients with NASH. CLINICALTRIALS.

GOV NUMBER:

NCT03421431 LAY SUMMARY: Non-alcoholic fatty liver disease is a chronic hepatic disease that can progress to non-alcoholic steatohepatitis (NASH), which is associated with an increased risk of cirrhosis and liver cancer. Results from this phase II study support continued development of EDP-305, an oral farnesoid X receptor agonist, for the treatment of patients with NASH.

News (Medical) associated with EDP-305

12 Dec 2022

·www.prnewswire.com

Propulsion of Nonalcoholic Steatohepatitis Pipeline as Novel and Extensive 150+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of nonalcoholic steatohepatitis has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Nonalcoholic Steatohepatitis and the growing research and development activities drive the market. The Companies developing the potential therapies in the last stage of development include Madrigal Pharmaceuticals, Inventiva, Boehringer Ingelheim, and several others. LAS VEGAS, Dec. 12, 2022 /PRNewswire/ -- DelveInsight's ' Nonalcoholic Steatohepatitis Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline nonalcoholic steatohepatitis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the nonalcoholic steatohepatitis pipeline domain. Key Takeaways from the Nonalcoholic Steatohepatitis Pipeline Report DelveInsight's nonalcoholic steatohepatitis pipeline report depicts a robust space with 130+ active players working to develop 150+ pipeline therapies for nonalcoholic steatohepatitis treatment. Key nonalcoholic steatohepatitis companies such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others are evaluating nonalcoholic steatohepatitis drugs to improve the treatment landscape. Promising nonalcoholic steatohepatitis pipeline therapies in various stages of development include TERN-101, SNP-610, LJN452 (tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others. In November 2022, Sagimet Biosciences announced positive interim data from its Phase IIb clinical trial (FASCINATE-2) with denifanstat, a fatty acid synthase (FASN) inhibitor, in non-alcoholic steatohepatitis patients. Data showed statistically significant improvements across key markers of NASH, reinforcing results observed in earlier studies, including statistically significant reductions in markers of liver fat, inflammation, and fibrosis. There were no treatment-related serious adverse events, with the majority of adverse events mild to moderate in nature (Grade 1 and 2). Additional interim data are expected in early 2023. In November 2022, Inventiva announced that the United States Patent and Trademark Office granted a patent (U.S. Patent No. 11,504,380) that protects the use of lanifibranor for the treatment of cirrhotic patients at risk of progressing from compensated stage to decompensated stage. This patent will expire on November 8, 2039. This patent further expands the intellectual property protection of lanifibranor in the United States for use in patients with cirrhotic NASH. In October 2022, Galectin Therapeutics, Inc. reported the positive outcome of its second data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase IIb/III study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The objective of this second independent DSMB was further to review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, the DSMB concluded that NAVIGATE could continue as designed, without modifications. In September 2022, Inventiva and Chia Tai-Tianqing Pharmaceutical Group entered into a licensing and collaboration agreement to develop and commercialize lanifibranor, if approved, for the treatment of nonalcoholic steatohepatitis and potentially other metabolic diseases in mainland China, Hong Kong, Macau, and Taiwan. In June 2022, Poxel SA announced that the U.S. Patent and Trademark Office (PTO) has issued to Poxel US Patent No. 11319313, which represents a new patent for PXL065, a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which is being investigated in Phase II stage of clinical trial evaluation for the treatment of Nonalcoholic steatohepatitis (NASH). In May 2022, Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to Pfizer's investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). In May 2022, Hepion Pharmaceuticals, Inc. announced that it has entered into a clinical collaboration with HepQuant, a Denver-based, privately held company with novel, proprietary investigational technology for evaluating liver function and health in patients with chronic liver diseases. Hepion will incorporate the HepQuant 'SHUNT' test into a dedicated Phase IIb clinical trial in presumed NASH F3 subjects. In February 2022, the US Food and Drug Administration (FDA) granted a Fast-Track Designation to Axcella Therapeutics' AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. In January 2022, LISCure Biosciences announced that it had executed a research collaboration agreement with Mayo Clinic for new drug development for rare liver diseases. LISCure Biosciences Inc. has executed a research collaboration agreement with US based-Mayo Clinic for new drug development for rare liver diseases. Request a sample and discover the nash drugs in development 2022 @ Nonalcoholic Steatohepatitis Pipeline 2022 Report The nonalcoholic steatohepatitis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage nonalcoholic steatohepatitis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the nonalcoholic steatohepatitis clinical trial landscape. Nonalcoholic Steatohepatitis Overview Nonalcoholic steatohepatitis (NASH) is a type of liver inflammation and damage caused by fat buildup. It is one of several conditions known as nonalcoholic fatty liver disease. Nonalcoholic fatty liver disease is classified into two types: isolated fatty liver, in which only fat accumulates, and nonalcoholic steatohepatitis, in which fat, inflammation, and liver cell damage occur. NASH does not usually cause symptoms. Most people with NASH feel fine and are unaware that they have it. As NASH progresses and liver damage worsens, a patient may experience fatigue, weight loss, general weakness, and acne in the upper right part of the belly. Screening for nonalcoholic fatty liver disease in the general population is not advised. It is usually considered after discovering unexplained liver enzyme levels, or imaging reveals hepatic steatosis. A patient's medical history, a physical exam, and tests for nonalcoholic steatohepatitis are used by doctors. Want to discover how the Nash treatment pipeline will look like? Request for sample @ NASH Drug Pipeline 2022 A snapshot of the Nonalcoholic Steatohepatitis Pipeline Drugs mentioned in the report: Want to know how nash dash the pipeline race is for new agents? Download the sample page @ NASH Clinical Trials Nonalcoholic Steatohepatitis Therapeutics Assessment The nonalcoholic steatohepatitis pipeline report proffers an integral view of nonalcoholic steatohepatitis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Nonalcoholic Steatohepatitis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intravenous, Parenteral, Oral, Subcutaneous Therapeutics Assessment By Molecule Type: Antibody, Biologic, Cell therapy, Peptide, Protein, Small molecule Therapeutics Assessment By Mechanism of Action: Adiponutrin inhibitor, Diacylglycerol O acyltransferase inhibitor, Adiponutrin modulator, RNA interference, Glucagon like peptide 1 receptor agonist, Ornithine decarboxylase stimulant, Farnesoid X-activated receptor agonist, Thyroid hormone receptor beta agonist, Mitochondrial membrane transport protein modulator, Thyroid hormone receptor beta agonists, Peroxisome proliferator-activated receptor alpha agonist Key Nonalcoholic Steatohepatitis Companies:Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others. Key Nonalcoholic Steatohepatitis Pipeline Therapies: TERN-101, SNP-610, LJN452(tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others. Dive deep into rich insights for nonalcoholic steatohepatitis research; visit @ NASH Treatment Pipeline Table of Contents For further information on the most promising nash drugs, reach out @ NASH Medication Pipeline Related Reports Nonalcoholic Steatohepatitis Epidemiology Nonalcoholic Steatohepatitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted nonalcoholic steatohepatitis epidemiology in the 7MM. Nonalcoholic Steatohepatitis Market Nonalcoholic Steatohepatitis Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key nonalcoholic steatohepatitis companies, including Boehringer Ingelheim, Oramed Pharmaceuticals, ENYO Pharma, Terns Pharmaceuticals, Cirius Therapeutics, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key non-alcoholic fatty liver disease companies including AstraZeneca, Novartis, Pfizer, Roche, among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced non-alcoholic fatty liver disease companies, including AstraZeneca, Novartis, Pfizer, Roche, among others. Non-Alcoholic Fatty Liver Disease Epidemiology Non-Alcoholic Fatty Liver Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted non-alcoholic fatty liver disease epidemiology in the 7MM. Other Trending Reports Alcohol Use Disorder Market | Liver Cancer Market | Alcoholic Hepatitis - Market | Acute Liver Failure - Market | Liver Angiosarcoma - Market | Liver Cirrhosis - Market | Chronic Liver Disease - Market | Advanced Liver Cancer - Market | Acute On Chronic Liver Failure (ACLF) Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research LLP

Phase 2License out/inFast Track

19 Nov 2021

·endpts.com

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.

04 Oct 2021

·www.biospace.com

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 Deals associated with EDP-305

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	Phase 2	US	Enanta Pharmaceuticals, Inc.	25 Apr 2018
Nonalcoholic Steatohepatitis	Phase 2	CA	Enanta Pharmaceuticals, Inc.	25 Apr 2018
Nonalcoholic Steatohepatitis	Phase 2	FR	Enanta Pharmaceuticals, Inc.	25 Apr 2018
Nonalcoholic Steatohepatitis	Phase 2	NZ	Enanta Pharmaceuticals, Inc.	25 Apr 2018
Nonalcoholic Steatohepatitis	Phase 2	PR	Enanta Pharmaceuticals, Inc.	25 Apr 2018
Nonalcoholic Steatohepatitis	Phase 2	GB	Enanta Pharmaceuticals, Inc.	25 Apr 2018
Primary Biliary Cholangitis	Phase 2	US	Enanta Pharmaceuticals, Inc.	27 Dec 2017
Primary Biliary Cholangitis	Phase 2	AU	Enanta Pharmaceuticals, Inc.	27 Dec 2017
Primary Biliary Cholangitis	Phase 2	AT	Enanta Pharmaceuticals, Inc.	27 Dec 2017
Primary Biliary Cholangitis	Phase 2	BE	Enanta Pharmaceuticals, Inc.	27 Dec 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04378010 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis	98	EDP-305 1.5 mg (EDP-305 1.5 mg)	rovuesbqxu(beugtqvnis) = ibhbajdytp onjiosqyzi (avaawhoacq, wfjeykmmws - scjfyzihwz) View more	-	19 May 2023
				EDP-305 2 mg (EDP-305 2 mg)	rovuesbqxu(beugtqvnis) = mimigpzcxi onjiosqyzi (avaawhoacq, tzfuyrodel - gjutcmajet) View more
NCT03421431 (Pubmed \| J Hepatol)	Phase 2	Nonalcoholic Steatohepatitis	134	EDP-305 1 mg	mgltsznhex(quoacgrvzz) = pyetdcendz vuzmsfbtik (bpfxkrteuv ) View more	-	02 Nov 2021
				EDP-305 2.5 mg	mgltsznhex(quoacgrvzz) = jgrjuzofaw vuzmsfbtik (bpfxkrteuv ) View more
NCT03421431 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis	134	Placebo	lxjjkbgqud(rtpkwpkuav) = koqkofdrmd rqezxqnevd (ujaqdgjjai, uwywrmfqso - pasangrxou) View more	-	16 Sep 2021
NCT03394924 (CTgov)	Phase 2	Primary Biliary Cholangitis	68	EDP-305 1 mg (EDP-305 1 mg)	ctsyjwkbhl(krrfftmfcf) = mlsmukovcc whoahypeje (asjzyvfmur, sphfquorck - hykjerislo) View more	-	18 May 2021
				EDP-305 2.5 mg (EDP-305 2.5 mg)	ctsyjwkbhl(krrfftmfcf) = uuvehhhtsn whoahypeje (asjzyvfmur, ymsnfuckpk - zqlkushjae) View more
EDP-305 (NASH_TAG2018)	Not Applicable	serum 7-_-hydroxy-4-cholesten-3-one (C4)	146	EDP-305	bcpjyscvgg(lkyuaquqny) = No Grade 4 AEs reported awfqpudywf (nuhgcqipek ) View more	Positive	04 Jan 2018
				Placebo
NASH_TAG2017	Not Applicable	Fatty Liver	-	EDP-305 30mg/kg	dutphdaaun(ehtkyoyhhd) = wmkizmktzr myqrotxaxm (kwbtuhqtlc ) View more	Positive	05 Jan 2017

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