GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases. Our translational disease-driven research approach is based on strong expertise, featuring in-house knowledge of drug and diagnostic design and development. A pioneer in the field of nuclear receptor-based drug discovery, GENFIT has a rich history and strong scientific heritage spanning more than two decades. This approach, along with our strong bioinformatics capabilities, enables us to discover and develop drug candidates and diagnostic technologies. Professor Bart Staels, a world-renowned expert in nuclear receptors, co-founded GENFIT, and has played a key role in shaping our company’s expertise over the years. Today, he is chair of the Scientific Advisory Board, lending his unique experience and essential know-how, and supporting our role as an innovative leader in the discovery of solutions for the field.
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- Nationally (across the country)
Targeting Diseases with High Unmet Medical Needs
We are committed to improving outcomes for patients with unmet medical needs, focusing on liver and metabolic diseases with limited treatment options.
We are exploring elafibanor as a potential candidate for the treatment of primary biliary cholangitis (PBC), a chronic disease in which bile ducts in the liver are gradually destroyed. The damage to bile ducts can inhibit the liver’s ability to rid the body of toxins, and may lead to cirrhosis. In December 2018, we announced positive results from our Phase 2 clinical trial evaluating elafibranor for the treatment of PBC. Elafibranor was then granted Breakthrough Therapy Designation by the FDA. A Phase 3 pivotal trial, ELATIVE™, is currently enrolling.
We also have a long experience in nonalcoholic steatohepatitis, or NASH. NASH is a chronic, potentially progressive, liver disease impacting millions of people worldwide and is the most severe form of nonalcoholic fatty liver disease (NAFLD). NASH disease activity is characterized by fat accumulation, inflammation and injury of the liver—increasing the risk of fibrosis or scarring. The disease carries no obvious symptoms in its early stages and lacks widely available non-invasive tests specifically developed for diagnosis. As a result, NASH remains largely underdiagnosed, despite severely impacting the health and function of the liver.
We have designed a novel diagnostic technology to improve early diagnosis of this disease, and developed NIS4™, a proprietary GENFIT-developed technology. NIS4™ underlies a novel, non-invasive, blood-based molecular biomarker test intended to identify at-risk NASH (NAFLD Activity Score ≥4 and Fibrosis stage ≥2) in patients with metabolic risk factors.
A research program designed to discover novel anti-fibrotic molecules, with a priority given to liver
Fibrosis, also allowed the identification of the effect of nitazoxanide, or NTZ, on liver fibrosis, based on the use of a phenotypic screening approach. An investigator-initiated POC trial for NASH-induced fibrosis has been launched by Dr. Stephen Harrison and is currently underway.
Developing a Competitive Market-Access Strategy
GENFIT’s clinical experience provides us with a solid foundation and supports our long-term objective of becoming a commercial company. We intend to build upon our pioneer approach and leadership in NASH diagnostics to achieve our goal of bringing our diagnostic technology to patients in need. We also intend to bring our drug candidates to patients in need in the field of specialty care indications and orphan diseases, such as PBC.
Our foremost goal is to contribute to worldwide health innovation by addressing unmet medical needs in cholestatic and chronic metabolic liver diseases.
Core values are the beliefs, philosophies, and principles that drive our business. They impact the experiences of our employees, as well as the relationships we develop with our community, customers, partners, and shareholders.
We are deeply committed to improving the health and quality of life of patients affected by cholestatic and chronic metabolic liver diseases.
We seek new ways to advance science and medicine, with the goal of optimizing care for patients.
We pioneer new approaches and innovative technologies to contribute to and to advance quality solutions in patient care.
We adapt ourselves and persevere in looking for efficiency and success in developing and bringing to the market first or best-in-class diagnostic and therapeutic solutions for patients.
We bring together talented employees with unique perspectives and experiences, and recognize and value diversity as a source of strength. We ensure that all employees and stakeholders are treated equally with dignity and respect.
We strive to create value and ensure that our success relies on working with others across industries and geographies.
We deliver true and accurate information to our partners and stakeholders and build our business relationships with honesty and transparency.
We demand of ourselves and others the highest ethical standards and we conduct our business in a socially and environmentally sustainable manner.
t is our policy to conduct business in a responsible way that minimizes environmental impact. We are committed to reducing waste generation and adhering to compliant and responsible methods of waste disposal. These actions limit environmental risk by employing safe technologies and operating procedures, and by following strict protocols in the event of an accident or emergency.
Our activities do not currently include industrial production or distribution, therefore there is no significant consumption of raw materials, nor release of greenhouse gases into the environment.
Our research operations are guided by an extremely constrained regulatory framework; we operate in full compliance with those regulations, and possess the necessary approvals for the conduct of these research activities.
Although our environmental impact is minimal, we actively take measures to protect and preserve our environment. These steps include the reduction of paper consumption, using recycled paper, recycling office consumables, and sorting and reducing household waste.
Ethics and Transparency
As a matter of policy, we promote a high standard of integrity by conducting our affairs in an honest and ethical manner.
We rely on trusted subcontractors to support a significant portion of our business activities, particularly those requiring specific regulatory approvals, such as Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP). Our product manufacturing is supported by subcontractors, as are our clinical studies in humans.
Monitoring the various subcontractors involved in all of our activities is essential, because quality and regulatory compliance are paramount in the health field. We perform regular audits of our subcontractors following an annual audit plan that provides for regular and rigorous monitoring of all of our subcontracted activities.
Loyalty and Code of Ethics
We operate in accordance with GENFIT’s code of business conduct and ethics.
We foster a culture of accountability, and we believe that our commitment to the highest level of ethical conduct should be reflected in all of the Company’s business activities.
All employees, officers, and directors must act in accordance with the language and spirit of GENFIT’s Code of Ethics: representing the corporate ethos in all aspects of life, exercising reasonable judgment when conducting business, and following appropriate behavioral norms. Any actions that violate the law or this Code may result in negative consequences for GENFIT and the individuals involved.
We respect international human rights standards for our own workforce, and apply the Universal Declaration of Human Rights in our operations. We are compliant with the local labor codes.
All of the service providers we employ, such as those conducting our clinical trials, but also the ones we employ in other departments (commercial, drug supply, etc.), ensure their employees have the qualifications and experience required to conduct a study in accordance with the GCP. Each commits to scrupulous compliance with the directives of the Ethics Committee concerned, the provisions of the Declaration of Helsinki, the recommendations of the World Health Organization and the ICH, as well as all laws and applicable local and/or national regulations as most recently amended and to all the other provisions established by the regulatory authorities (and in particular articles L. 4113-6 and L. 4113-9 of the Public Health Code.).