Capitalizing on our strong scientific heritage
Our pioneering research is based on a strong heritage, stemming from in-house knowledge and our desire to strive for excellence. Our drug discovery efforts are based on selecting specific nuclear receptors as targets and utilizing rational drug design to optimize our drug candidates.
This strong skill base associated to our scientific and clinical expertise, translational disease-driven approach and strong bioinformatics capabilities, have allowed us to build a solid scientific platform enabling us to discover and develop our drug candidates and diagnostic tools. 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 sits as chair of the Scientific Advisory Board, lending decades of experience and essential know-how, supporting our role as an innovative leader in the discovery of solutions for the metabolic field.
Targeting diseases with high unmet medical needs
Nonalcoholic steatohepatitis, or NASH, is a liver disease that affects millions of people for which there are currently no approved therapies. NASH may ultimately lead to life-threatening conditions like cirrhosis, liver failure or liver cancer requiring liver transplant. We are currently evaluating our most advanced drug candidate, elafibranor, in a pivotal Phase 3 clinical trial as a potential treatment for adult NASH and in a Phase 2 for pediatric NASH.
NASH, a silent disease, often does not present with any symptoms in patients before the first signs of liver failure, which explains why the disease is notably under-diagnosed. At GENFIT, we know therapies and diagnostics are interrelated and mutually supportive. As a pioneer in the field, we embarked on creating a solution and developed NIS4, a non-invasive in vitro diagnostic, or IVD, blood test, to identify patients with NASH who may be appropriate candidates for drug therapy.
We are also developing elafibranor for the treatment of PBC, a chronic, progressive liver disease that can cause serious liver complications and, if left untreated, progress to cirrhosis. In December 2018, we announced positive results from our Phase 2 clinical trial evaluating elafibranor for the treatment of PBC. Elafibranor met the primary and secondary endpoints of the trial with statistical significance, supporting our decision to move the compound forward in a Phase 3 clinical trial. We believe elafibranor has the potential to reduce the worldwide PBC burden.
We are also developing other drug-candidates such as nitazoxanide, or NTZ, currently under clinical evaluation in a Phase 2 POC trial for NASH induced fibrosis, and exploring a RORgt program for various auto immune diseases.
Driving a genuine patient-centric approach
At GENFIT, we believe a comprehensive approach to diseases begins by focusing on the patient. To do so, we have made it a priority to create programs and robust solutions, such as The NASH Education Program™.
The NASH Education Program™, is a program designed to raise awareness about NASH and an example of our proactive approach to encourage better public health and patient care. Liver diseases are still subject to prejudice and surrounded by wrong assumptions about the risk factors, leading to poor disease management and hindering proper patient care. Patients need to in better understand the risk factors and causes of the disease to enable early diagnosis. Disseminating NASH knowledge within the medical community and providing new tools that can improve healthcare is essential. In partnership with patient advocacy groups and learned societies, we believe education and awareness are key to successfully managing this widespread disease.
We are proud to be an innovative company that places both patients and medical community at the center through ground breaking initiatives.
Developing a competitive market-access strategy
GENFIT’s recent positive clinical results in NASH and PBC are a solid foundation and support our long-term objectives of becoming a commercial company. We intend to build upon our leadership in the metabolic field and achieve our goals of commercializing elafibranor and launching diagnostic tools.
Our foremost goal is to contribute to the worldwide health innovation by addressing unmet medical needs in NASH and PBC.