GENFIT in deal to enhance Medical Knowledge & Landscape of NASH research

GENFIT has signed an agreement for a NASH Registry Project with Pinnacle Clinical Research Center, directed by Dr. Stephen Harrison, San Antonio, TX, USA.

Genfit says it sees that this agreement could improve the NASH patient referral process between the different specialties involved in this pathology: endocrinology, diabetology, gastroenterology and hepatology. According to the company, linking Hepatology Research Centers with Endocrine Clinics indeed provides for a unique opportunity to target the patient at greatest risk of NASH. These same patients are likely to carry the greatest risk for moderate to advanced fibrosis, Genfit’s statement reads.

Under this agreement, a set of NASH parameters will be provided to each site, that will be used to screen for patients that may qualify for the NASH Registry.

The data generated will be used to inform the medical community about overall prevalence, natural history of the disease, as well as progression of co-morbidities. As such it will further increase the global understanding of NASH and its comorbities in patients at risk, it has been said in the Genfit’s announcement.

Furthermore, Genfit will be granted access to the collected data, provided that the release of the de-identified data has been approved by the local ethics committee and patients.

Dr. Stephen Harrison, Pinnacle Clinical Research, San Antonio, TX, USA, and Member of the international steering committee of the Phase 3 RESOLVE-IT study in NASH commented: “This agreement is a first step of what will in principle become a large patient registry program in NASH. It is really exciting to have such framework now fully set-up, because it means we are in a position to start collecting essential patient data that will complement clinical trial data in a very useful and valuable way for the whole scientific and medical community. As a hepatologist caring for NASH patients on a regular basis, I`m particularly well aware of the need for a multidisciplinary approach to address all challenges related to this emerging but silent disease. In this respect, a well designed form of collaboration – between hepatologists, gastroenterologists, endocrinologists and diabetologists who treat patients at risk – is certainly a key success factor in the fight againt this disease. This is the reason why we have decided to set-up Pinnacle`s NASH Registry, and also the reason why we are now very happy to get the support of GENFIT to develop this initiative one step further.”

Sophie Mégnien, Chief Medical Officer (CMO) of GENFIT commented: “It is important for us to take such concrete steps in relation to the patient referral process, because NASH involves different specialties. We all know that NASH is much more than a simple liver disease and this is why, today, all hepatologists who have been working on the disease for a long time are convinced of the need to collaborate with diabetologists and endocrinologists, given the direct correlation between the cardiometabolic condition of NASH patients and the state of their liver. But once you have said this, there is still a lot to do to make things happen. This is why we wanted to contribute to a program like Pinnacle`s NASH Registry, that involves highly relevant and cross-disciplinary experts. The whole medical community will undoubtedly be able to capitalize on this work in the near future. Note that this collaboration is perfectly aligned with other initiatives taken by GENFIT around disease awareness.” 

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