The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months. The main questions it aims to answer are:
* Does NTZ treatment of diarrheal Cryptosporidium infection lower the number of days of diarrhea?
* Does NTZ treatment of diarrheal and non-diarrheal Cryptosporidium infection lower the number of days that parasites can be found in the stool?
Researchers will compare NTZ to a placebo (a look-alike substance that contains no drug) to see if NTZ works to treat Cryptosporidium.
Participants will:
* Take NTZ or placebo for 3 days
* Receive regular visits from field research assistants
* Provide blood and urine samples

Start Date01 Feb 2025

Sponsor / Collaborator

Johns Hopkins Bloomberg School of Public Health

[+1]

NCT05157269

/ WithdrawnPhase 3

Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness

The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective for treatment of mild COVID-19 illness. Adults and adolescent participants will be followed for approximately 28 days.

Start Date01 Aug 2024

Sponsor / Collaborator

Romark, L.C.

NCT05157243

/ WithdrawnPhase 3

Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness

The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective in treating mild or moderate COVID-19 illness in adults and adolescents at highest risk for severe outcomes. Each participant will be followed for approximately 28 days.

Start Date01 Aug 2024

Sponsor / Collaborator

Romark, L.C.

100 Clinical Results associated with Nitazoxanide

100 Translational Medicine associated with Nitazoxanide

100 Patents (Medical) associated with Nitazoxanide

1,733

Literatures (Medical) associated with Nitazoxanide

01 May 2025·ANALYTICAL BIOCHEMISTRY

In-vivo implementation of the HPTLC methodology to rat plasma for the concurrent determination of a novel combination therapy for the management of COVID-19 (favipiravir and nitazoxanide)

Article

Author: Edrees, Fadwa H ; Abdelrahman, Maha M ; Ahmed, Amal B

The 2019 coronavirus outbreak has prompted scientists to investigate pharmaceuticals to prevent the spread of the disease. Favipiravir (FAV) has received Food and Drug Administration FDA approval for the treatment of various viral infections with notable efficacy in clinical trials for COVID-19. Nitazoxanide (NTZ) is a broad-spectrum antiparasitic and antiviral agent used for the treatment of parasitic illnesses. Recently, the antiviral medications FAV and NTZ have been utilized therapeutically as early antiviral combination therapy for COVID-19, highlighting their safety, efficacy, and immunomodulatory effects. Despite several clinical studies on both FAV and NTZ, no analytical method has been developed for their concurrent detection. The objective of this study is to develop a TLC-densitometric method for their assessment and application to rat plasma. FAV, NTZ, and tizoxanide (the active metabolite of nitazoxanide (TZM)) were simultaneously determined using an HPTLC method embracing sulfasalazine as an internal standard (IS). Silica gel 60 F254 used as the stationary phase for chromatographic separation, the mobile phase consisted of chloroform-methanol-formic acid (9.5:0.5:0.2, v/v/v), with UV detection at 230 nm demonstrating linearity within the range of 0.5-5 μg/band. The proposed methodology has been shown to effectively measure the analyzed elements in both pure form and in-vivo rat plasma.

01 Mar 2025·CLINICAL IMMUNOLOGY

Effect of repurposed metabolic drugs on human macrophage polarization and antitumoral activity

Article

Author: Oyarce, Cesar ; Vizcaino-Castro, Ana ; Hoogeboom, Baukje Nynke ; Boerma, Annemarie ; Daemen, Toos ; Chen, Shipeng

AIM:

This study aimed to investigate whether the polarization of monocyte-derived macrophages towards an anti-inflammatory phenotype could be hindered by modulating cellular metabolism. Several metabolic drugs were selected: Perhexiline (PerHx) and Nitazoxanide (NTZ) targeting fatty acid oxidation, CB839 (Telaglenastat) targeting glutaminolysis and Metformin (Metf) targeting the mitochondrial electron transport chain.

RESULTS:

Our findings demonstrate that the presence of PerHx, NTZ, and CB839 during IL-4-mediated macrophages polarization impaired the acquisition of full anti-inflammatory phenotype, as evidenced by reduced expression of CD163 and CD209 and decreased secretion of CCL17 chemokine. Besides, CB839 induced tumoricidal activity in macrophages, comparable to that observed in macrophages activated by LPS and IFNγ.

CONCLUSION:

This study reveals that targeting glutamine metabolism with CB839 effectively blocks the IL-4-induced anti-inflammatory phenotype in macrophages and enhances their tumor-killing capability. Our results provide a compelling rationale for repurposing metabolic drugs to create a pro-inflammatory tumor microenvironment, thereby potentially enhancing the efficacy of current immunotherapies.

03 Feb 2025·JOURNAL OF TRAVEL MEDICINE

Challenges in diagnosis and treatment of fascioliasis in a non-endemic country

Article

Author: Dor, Shira ; Leshem, Eyal ; Schwartz, Eli ; Amitai, Michal ; Grossman, Tamar ; Hochstein, David ; Saed, Rashed ; Cohen-Poradosu, Ronit ; Mathiesen, Inger ; Green, Hefziba

A returned traveller from Asia presented with prolonged fever, abdominal pain, and eosinophilia. Abdominal CT revealed hypodense lesions of the liver. Fascioliasis was clinically suspected. Serology and triclabendazole are unavailable in Israel; therefore, empiric treatment with nitazoxanide and transfer to Denmark for definitive serodiagnosis and triclabendazole treatment was necessary.

News (Medical) associated with Nitazoxanide

13 Nov 2024

·www.globenewswire.com

GENFIT Announces Corporate Updates and Upcoming Participation at The Liver Meeting® 2024

PBC program (licensed to Ipsen): Ipsen to present new data on elafibranor at The Liver Meeting® 2024Launch of Iqirvo® (elafibranor)1 on track with expectations; encouraging feedback from healthcare providers and payers in the U.S.UK NICE reimbursement approved and first reimbursed sales in Germany in October 2024Next €26.5M milestone payment by Ipsen pending a third pricing and reimbursement approval in Europe Scientific progress in ACLF to be featured at The Liver Meeting® 2024, with 4 posters presenting new preclinical data, and 3 events bringing together key ACLF stakeholders Results from UNVEIL-IT® Phase 2 trial evaluating VS-01 in ACLF now expected in 2H25; protocol modified to improve recruitment and trial design New insights and emerging scientific trends incorporated into our ACLF development plan, with data readout from 4 clinical trials anticipated by the end of 2025, including data from 3 new clinical trials to be launched in 1H25, in addition to UNVEIL-IT® Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 13, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today provided a corporate update ahead of The Liver Meeting 2024®2. Pascal Prigent, CEO of GENFIT said: “We are thrilled to see that Ipsen continues to execute as planned and make great progress with elafibranor, on both commercial and regulatory fronts in the U.S. and Europe, further enhancing our financial outlook for the rest of this year and beyond. We continue to build on our momentum in Acute on-Chronic Liver Failure (ACLF), where we plan to initiate multiple clinical studies in 2025 and report Phase 2 UNVEIL-IT® data from our VS-01 program. We recently updated the Phase 2 UNVEIL-IT® study protocol to improve trial enrollment and worked with centers to address logistical hurdles associated with the use of new technology. We are very confident that with these changes, along with supporting several exciting initiatives that will help better identify patients that are particularly at risk, we have taken the right steps to put GENFIT in a strong position to advance this program forward for patients.” I. Positive momentum for the Primary Biliary Cholangitis (PBC) program Ipsen recently reported positive commercial and regulatory developments with Iqirvo®3 in the U.S. and Europe 4 5: U.S. launch progress is on-track after June 10, 2024 U.S. Food and Drug Administration approval following priority review6Ipsen received EMA7 approval on September 20, 2024 and the UK MHRA8 approval on October 9, 2024 followed by UK NICE9 approval on October 22, 2024 Recent reimbursement in Germany and the UK brings GENFIT closer to a €26.5M milestone payment, pending a third pricing and reimbursement approval in a major European country II. Strategic developments across the ACLF franchise GENFIT at The Liver Meeting 2024 GENFIT will present pre-clinical data as part of its ACLF franchise with the following posters: VS-01: Effect of VS-01 on Acute-on-Chronic Liver failure-related toxins such as lipopolysaccharide and hydrophobic bile acids in vitro (poster #1603)SRT-015: Intravenous administration with the ASK1 inhibitor SRT-015 alleviates liver injury and systemic inflammation in disease models of liver failure (poster #1597)CLM-022: Investigational drug CLM-022, a potent inhibitor of NLRP3 inflammasome-mediated pyroptosis, as a potential treatment for acute and chronic inflammatory liver diseases (poster #2232)NTZ: Efficacy of Nitazoxanide (NTZ) in Pathogen-Associated Molecular Patterns (PAMPs)-induced disease models (poster #2222) GENFIT will also lead 3 key events on ACLF: ACLF KOL Advisory Board (November 14, 2024), bringing together 9 leading experts from Europe and the United StatesACLF Patient Advocacy Council (November 16, 2024), with the participation of Professor Debbie Shawcross, MBBS PhD FRCP, Professor of Hepatology and Chronic Liver Failure, Institute of Liver Studies King’s College London, UK and EASL Vice-Secretary), the Global Liver Institute (GLI), the European Liver Patients’ Association (ELPA), and real-life patients and caregiversACLF Morning Insights session (November 17, 2024), focused on addressing unmet needs, diagnostics, and guidelines for ACLF, with Dr. Jasmohan Bajaj, Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University and Richmond VA Medical Center in Richmond, Virginia, USA. The event will also offer an intensivist’s perspective with Dr. William Bernal, Professor of Liver Critical Care Medicine in the Liver Intensive Therapy Unit at the Institute of Liver Studies at King’s College Hospital, London and Member of the EASL-CLIF Consortium Steering Committee. It will also outline GENFIT’s clinical roadmap and highlight the patient and caregiver experience, via GLI and ELPA. Key strategic insights and emerging trends uncovered through unique sources and channels Over the last 12 months, GENFIT has made strides in understanding the ACLF continuum, enriching our body of knowledge compared to the knowledge available in the field at the time of our pivot to ACLF. Key takeaways derived from these workstreams will inform the design of on-going and upcoming trials evaluating VS-01, NTZ and SRT-015. These insights will also help further strategize the research and clinical development of CLM-022 and VS-02-HE. UNVEIL-IT®3 clinical and operational improvements: As announced in September 202410, lower than expected trial enrollment prompted a protocol amendment to better accommodate patient care logistics and comorbidities. These recent modifications require time before they can be implemented in every investigational site and before they can significantly impact the enrollment curve. Therefore, we are now guiding 2H25 for UNVEIL-IT results. The two main points of focus for our improvement efforts have been: Inclusion and exclusion criteria were overly restrictive for a patient population with multiple co-morbidities. As we accumulated data to better characterize these patients, we collaborated with investigators and KOLs to modify the protocol and better address the targeted population. Logistical challenges are inherent to the introduction of any new technology. In the case of VS-01 the necessary steps in the reconstitution process, and the limitation of a clinical trial setting, had previously restricted patient enrollment windows. By generating additional stability data, we now offer enhanced storage flexibility for study material, enabling clinical trial centers to use VS-01 more frequently. Additionally, we have been working on the development of an innovative medical device which should be available next year and will further streamline the reconstitution process. Cutting-edge processing of Real-World Evidence: An in-depth analysis of medical claims data – leveraged through advanced A.I. and machine learning techniques from a targeted U.S. population of over 270,000 patients – provided pivotal insights into risk profiles within specific patient sub-populations of the ACLF continuum, as well as differences in referral dynamics, patient journeys and clinical management practices compared to Europe. Applying sophisticated algorithms uncovered epidemiological patterns and trends within this substantial dataset, generating actionable intelligence that enhances our understanding and supports more precise, data-driven decisions across our portfolio.Preclinical research: New preclinical models have been established with leading experts, serving as key enablers to deliver valuable data aimed at improving our understanding of our portfolio potential. To date, the data already generated encompasses a range of disease models and various formulations. This approach is designed to optimize asset positioning and refine population targeting, ultimately supporting strategic decision-making and maximizing impact across our therapeutic landscape. Collaboration with learned societies: Strategic partnerships, including with the European Foundation for the Study of Chronic Liver Failure (EF CLIF) and engagement with U.S. KOLs from NACSELD11, offered important insights through unique data sources encompassing several observational studies, while also accelerating and expanding discussions with key leaders in the field. This type of collaboration places GENFIT at the forefront of international research, advancing the understanding of ACLF pathophysiology and uncovering novel approaches for the treatment of this syndrome. Data readout from 4 clinical trials anticipated by the end of 2025 Building on insights from the upcoming KOL Advisory Board and additional real-world evidence anticipated by late November 2024, GENFIT will finalize the design of two new proof-of-concept studies evaluating VS-01 and NTZ, alongside a First-in-Human study for SRT-015 with GENFIT’s formulation. These trials are expected to launch in the first half of 2025, with data readouts expected by year-end. With Phase 2 data for UNVEIL-IT trial also anticipated by the close of 2025, GENFIT will deliver four clinical data sets in 2025, advancing three clinical-stage assets of our ACLF pipeline in parallel. Preclinical assets CLM-022: Preclinical Proof of Concept expected to be obtained by end of 2024VS-02-HE: Completion of Investigational New Drug (IND) enabling studies expected in 2025 III. GNS561 in KRAS-mutated cholangiocarcinoma The phase 1b/2a clinical trial is currently ongoing and preliminary data from Phase 1b is targeted by the end of 2024. Final data is expected by the end of 2025. IV. NIS2+® in MASH During The Liver Meeting 2024, GENFIT will also present new data on NIS2+®’s3 efficacy as a monitoring tool for patients with MASH12 with the following posters: NIS2+, an effective monitoring tool for tracking disease evolution in patients with fibrotic MASH (poster #2062)NIS2+, an effective tool for monitoring MASH resolution and fibrosis improvement in patients with at-risk MASH (poster #2063)Detecting MASH resolution and fibrosis improvement with NIS2+ in patients with at-risk MASH (poster #2067) Significant progress has been made since the recognition of NIS2+ as a key tool for detecting at-risk MASH in June 202413, as our technology is now also covering screening and monitoring needs, and not just diagnostics needs. With more than 20 clinical MASH trials using our technology, more publications are referring to it, highlighting the relevance of our solution. In March 2024, Rezdiffra™ (resmetirom) was the first drug approved in MASH in the United States. As a reminder, GENFIT signed a commercial agreement with Labcorp in 2021 to provide broad clinical availability of the test to specialty and primary care physicians across the U.S. and Canada. Our business goal is now to develop an IVD version of the test, either in collaboration with a commercial partner or by ourselves. ABOUT GENFIT GENFIT is a late-stage biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated in the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration, the European Medicines Agency and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about ability to receive upcoming milestone payments from Ipsen pursuant to our Licensing and Collaboration agreement and the effect of Ipsen commercial performance on our financial outlook, availability and timing of results of our UNVEIL-IT clinical trial in ACLF as well as four additional clinical programs, and the impact of changes to the UNVEIL-IT clinical trial protocol on improving trial enrollment and the timing and impact of development of a new medical device for VS-01 reconstitution. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, potential commercial success of elafibranor if approved, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2023 Universal Registration Document filed on April 5, 2024 (no. D.24-0246) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2023 Annual Report on Form 20-F filed with the SEC on April 5, 2024 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | Investors Tel: +33 3 2016 4000 | investors@genfit.com GENFIT | Media Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 Elafibranor is marketed and commercialized by Ipsen under the trademark Iqirvo®2 The Liver Meeting 2024® is a registered trademark of the American Association for the Study of Liver Diseases3 Iqirvo®, NIS2+® and UNVEIL-IT® are registered trademarks of GENFIT SA4 https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/10/24164500/Ipsen-YTD-2024-sales-presentation-1.pdf5 https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/10/24164500/Ipsen-YTD-2024-sales-presentation-1.pdf6 https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/10/24164500/Ipsen-YTD-2024-sales-presentation-1.pdf7 European Medicines Agency8 Medicines and Healthcare products Regulatory Agency9 UK National Institute for Health and Care Excellence10 https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-half-year-2024-financial-results-and11 North American Consortium for the Study of End-Stage Liver Disease12 Metabolic dysfunction-associated steatohepatitis13 https://ir.genfit.com/news-releases/news-release-details/genfit-new-easl-easd-easo-clinical-practice-guidelines-masld Attachment GENFIT Announces Corporate Updates and Upcoming Participation at The Liver Meeting® 2024

Phase 2License out/inDrug Approval

07 Nov 2024

·www.globenewswire.com

GENFIT Reports Third Quarter 2024 Financial Information

Cash and cash equivalents totaled €96.0 million as of September 30, 2024€59.7 million in revenues for the nine months ended September 30, 2024, including the €48.7 million milestone invoiced in June 2024 (received in August 2024) upon first sale of Ipsen’s Iqirvo® (elafibranor) in the U.S. for the treatment of Primary Biliary Cholangitis (PBC) Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland); November 7, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its cash position as of September 30, 2024 and revenue for the first nine months of 20241. Cash Position As of September 30, 2024, the Company’s cash and cash equivalents amounted to €96.0 million compared with €61.6 million as of June 30, 2024 and €77.8 million as of December 31, 2023. We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements until at least the start of the fourth quarter of 2025. This is based on current assumptions and programs and does not include exceptional events. In the first nine months of 2024, cash utilization is mainly the result of our research and development efforts in our ACLF franchise (notably VS-01, NTZ, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization is offset notably by the €48.7 million milestone received in August 2024 (invoiced in June 2024) upon first sale of Ipsen’s Iqirvo®2 (elafibranor) in the U.S. for the treatment of PBC. Revenue Revenue3 for the first nine months of 2024 amounted to €59.7 million compared to €14.3 million for the same period in 2023. Substantially all revenue for the first nine months is attributable to our Collaboration and License Agreement with Ipsen and related Transition Services Agreements. Revenue growth is due to a milestone payment invoiced to Ipsen in June 2024 (collected in August 2024) following the first commercial sale of Iqirvo in the U.S. Of the €59.7 million in revenues for the first nine months of 2024, €48.7 million was attributable to a milestone payment invoiced to Ipsen in June 2024 and €0.9 million was attributable to royalty revenue from U.S. sales of Iqirvo/elafibranor which commenced mid-June in application of the Collaboration and License Agreement with Ipsen signed in December 2021. The remainder is comprised of €9.3 million attributable to the partial recognition of deferred income of €40 million accounted for in accordance with IFRS 15, in application of the aforementioned licensing agreement, and €0.8 million generated from the services rendered under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and September 2023 respectively by GENFIT and Ipsen, in order to facilitate the transition of certain services related to the Phase 3 Elative®2 clinical trial until the complete transfer of the responsibility of the trial to Ipsen. ABOUT GENFIT GENFIT is a late-stage biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated in the accelerated approval of Iqirvo® (elafibranor4) by the U.S. Food and Drug Administration, the European Medicines Agency and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about Company’s eligibility to receive future milestone payments from Ipsen relating to the development and commercial launch of elafibranor in PBC and expected cash runway. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, potential commercial success of elafibranor if approved, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2023 Universal Registration Document filed on April 5, 2024 (no. D.24-0246) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2023 Annual Report on Form 20-F filed with the SEC on April 5, 2024 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2024 or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | Investors Tel: +33 3 2016 4000 | investors@genfit.com GENFIT | Media Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 Unaudited financial information under IFRS 2 Iqirvo® and Elative® are registered trademarks of GENFIT SA 3 Revenue recognized under IFRS 154 Elafibranor is marketed and commercialized in the U.S by Ipsen under the trademark Iqirvo®. Attachment GENFIT Reports Third Quarter 2024 Financial Information

License out/inFinancial StatementAccelerated Approval

24 Sep 2024

·www.globenewswire.com

GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA Accelerated Approval

September 23, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that the European Commission has conditionally approved Iqirvo®1 (elafibranor) 80mg tablets for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. This follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on July 26, 2024 and the U.S. FDA Accelerated Approval on June, 10, 2024 . Pascal Prigent, CEO of GENFIT, commented: “The approval of Iqirvo in the EU is another landmark moment for GENFIT. Iqirvo’s EU approval provides further validation of our scientific and clinical capabilities, demonstrating how we are capable of taking a drug candidate all the way from discovery to the end of a Phase 3, with Iqirvo now becoming a new treatment option for patients. The expected €26.5 million milestone payment upon Iqirvo’s pricing and reimbursement approval in three European countries, will enable us to drive forward with our robust pipeline for other severe liver diseases with high unmet need, including Acute On-Chronic Liver Failure.” Elafibranor, a 'first-in-class' molecule marketed and commercialized in the United States by Ipsen under the trademark Iqirvo since June 2024, was developed by GENFIT, from initial discovery to the conclusion of a 52-week Phase 3 clinical study. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021. Important safety information and recommendations for the use of Iqirvo are detailed in the Summary of Product Characteristics (SmPC), published in the European public assessment report (EPAR) and available in all official EU languages. The full SmPC can be found at: Iqirvo, INN-elafibranor (europa.eu). GENFIT is a late-stage biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, including pre-commercialization, was demonstrated in the FDA’s accelerated approval of Iqirvo® (elafibranor2) for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com 1 Iqirvo is a registered trademark by GENFIT SA 2 Elafibranor is marketed and commercialized in the U.S by Ipsen under the trademark Iqirvo The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalAccelerated Approval

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KEGG	Wiki	ATC	Drug Bank
D02486	Nitazoxanide	P01AX11	DB00507

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Approved

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Indication	Country/Location	Organization	Date
Cryptosporidiosis	US	Romark, L.C.	22 Nov 2002
Diarrhea	US	Romark, L.C.	22 Nov 2002
Giardiasis	US	Romark, L.C.	22 Nov 2002

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	US	Romark, L.C.	12 May 2020
Viral respiratory infection	Phase 3	US	Romark, L.C.	12 May 2020
Common Cold	Phase 3	US	Romark, L.C.	11 Sep 2018
Common Cold	Phase 3	PR	Romark, L.C.	11 Sep 2018
Enterovirus Infections	Phase 3	US	Romark, L.C.	11 Sep 2018
Enterovirus Infections	Phase 3	PR	Romark, L.C.	11 Sep 2018
Rhinovirus infection	Phase 3	US	Romark, L.C.	11 Sep 2018
Rhinovirus infection	Phase 3	PR	Romark, L.C.	11 Sep 2018
Influenza, Human	Phase 3	US	Romark, L.C.	01 Mar 2013
Influenza, Human	Phase 3	AU	Romark, L.C.	01 Mar 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04489381 (CTgov)	Phase 3	Rhinovirus infection \| Common Cold \| Enterovirus Infections	214	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	tayvzlaivf(ramhlxmkst) = otjuuuxcfo nncuperiki (wzrwlgvrgz, uiwduvncnb - htgvgaepka) View more	-	17 Oct 2024
				Placebo (Placebo)	tayvzlaivf(ramhlxmkst) = vogdwnzqmo nncuperiki (wzrwlgvrgz, pojenmkxet - xludbnxjqq) View more
UEGW2024	Not Applicable	Infectious Diseases	-	Levofloxacin, nitazoxanide, doxycycline, and lansoprazole (LNDL)	saygaukstn(noqfkbcfcm) = vxzlbggzxe tdjyuvhwcm (kadbtlqmsv, 75.73 - 91.27)	-	13 Oct 2024
				Moxifloxacin, nitazoxanide, doxycycline, and lansoprazole (MNDL)	saygaukstn(noqfkbcfcm) = luchphirbq tdjyuvhwcm (kadbtlqmsv, 73.57 - 90.01)
NCT04343248 (CTgov)	Phase 3	COVID-19 \| Viral respiratory infection	190	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	utxsarlkxa(sihjelpgod) = oajhzkbuow gqimmostpl (vqeunnikux, azfhmowgeb - zcolqtskkh) View more	-	08 Jul 2024
				Placebo (Placebo)	utxsarlkxa(sihjelpgod) = ktzmnotfts gqimmostpl (vqeunnikux, ezfmsuldtf - rwttymfuud) View more
NCT04359680 (CTgov)	Phase 3	COVID-19 \| Viral respiratory infection	1,407	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	dstnkzjclq(zofvogbozn) = ehvdxgyiwl tbixmldkck (vwmjwmordx, brranoxotn - tewwwwdyzx) View more	-	26 Jun 2024
				Placebo (Placebo)	dstnkzjclq(zofvogbozn) = gsuhsgdprg tbixmldkck (vwmjwmordx, vvunxvqqzi - iobyckixsp) View more
NCT04486313 (CTgov)	Phase 3	COVID-19	935	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	ihrrdmpnnp(iezbavnbsk) = vvreiukrxg kdypgoxbdn (yndfuzjmal, tntyfjzbbh - pokigbrhzn) View more	-	29 Mar 2024
				Placebo (Placebo)	ihrrdmpnnp(iezbavnbsk) = jcjalrzukh kdypgoxbdn (yndfuzjmal, bhyhufnact - sysssstzwk) View more
NCT03905655 (CTgov)	Phase 2	Hepatitis B, Chronic	51	Placebo Oral Tablet (Group 1)	xrdxxxuiop(dwlhfvpmpi) = juqitltzxi hecxgsdbpb (zihuebulni, lirankjljd - rpazoephmr) View more	-	07 Nov 2023
				Placebo Oral Tablet+Nitazoxanide (Group 2)	xrdxxxuiop(dwlhfvpmpi) = myjfshbcjq hecxgsdbpb (zihuebulni, tcpiowdpdp - cylqcfwjyr) View more
NCT03395405 (CTgov)	Phase 2	Gastroenteritis	31	Nitazoxanide (Nitazoxanide (500 mg))	eakcjdymii(pbgkqrodbr) = iqdricwhyz mgsdomulxs (oxylldsvoo, twngaekezp - giyokvnsle) View more	-	24 Oct 2022
				placebo (Placebo)	eakcjdymii(pbgkqrodbr) = wwjsgxscpa mgsdomulxs (oxylldsvoo, kugoxigvgw - vcadzosncn) View more
EASL2022	Not Applicable	Acute-On-Chronic Liver Failure	-	Nitazoxanide 100 mg/kg	jgiqkgktkn(phyvbjkbnq) = lahvkjxqdt zpkghyktyt (euwfnzwbnm ) View more	Positive	23 Jun 2022
				Vehicle	jgiqkgktkn(phyvbjkbnq) = txmkbzwwue zpkghyktyt (euwfnzwbnm ) View more
NCT04605588 (TriACT, CTgov)	Phase 2	COVID-19	7	Hydroxychloroquine+Nitazoxanide+ribavirin (Active Study Drug)	twrqguwgtg(mqjeblfqcl) = gkfwrboefv imvdgjezqp (qwsjsiwghk, ywwsvhkspu - gelhbzaqpq) View more	-	05 May 2022
				Placebo Hydroxychloroquine (Placebo)	twrqguwgtg(mqjeblfqcl) = ivknvqkmbd imvdgjezqp (qwsjsiwghk, feditiomdb - nzhcabnmgy) View more
NCT04486313 (Pubmed) Manual	Phase 3	COVID-19	1,092	nitazoxanide	ywkqslnknm(ebmzvyqvgn) = dvqmajdmhs ihezzkcrpx (kzsbshhjsi, 6.3) View more	Negative	28 Feb 2022
				Placebo	ywkqslnknm(ebmzvyqvgn) = dumunodtoe ihezzkcrpx (kzsbshhjsi, 7.2) View more

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