Connect with us

Biotech

Genfit is adapting its activities in accordance to the coronavirus pandemic

Biotech companies worldwide are trying to find a vaccine to halt the coronavirus pandemic. The French Group Genfit announced that it will suspend some of its trials. However, the company’s program in primary biliary cholangitis (PBC) and combination therapy program in Nash will be maintained. Genfit’s diagnostic solution continues to be deployed in clinical research.

Published

on

This picture show a scientist doing some experiments.

Genfit provided an update on the impact of the coronavirus on its business. First, the Phase 3 clinical trial in Nash (non-alcoholic steatohepatitis) with fibrosis “Resolve-It” continues. The biotech company is awaiting comments from the FDA, and their integration for the continuation of the study. According to the French group, the health crisis should not cause a significant delay in receiving these comments.

After careful consideration of the potential benefit of continued treatment for Nash patients, Genfit has also decided to continue the extension phase of the study. The group has, of course, taken all necessary safety measures to undergo these studies.

Born2Invest is a digital media website covering the biotech industry, among others. Our companion app allows you to get your daily dose of financial news. Born2Invest is a professionally curated digest of business, finance, and biotech news summaries from the most reputable news organizations around the world.

Some trials have been suspended due to the coronavirus pandemic

Genfit has discontinued, as recommended, all Phase 1 trials – including pharmacokinetics, food interaction and bioequivalence trials. These studies are necessary for the filing of a New Drug Application (NDA) for elafibranor in Nash.

Patient enrollment for a pediatric Nash trial and a Phase 2 liver lipid composition trial have also been suspended.

While its program in primary biliary cholangitis (PBC) and combination therapy program in Nash continues, with several projects underway, Genefit has decided to suspend the initiation of its Phase 2 trial in combination with treatment and the initiation of its Phase 3 trial in PBC patients.

All support activities related to the continuation of ongoing studies, or the initiation of new studies, will be maintained in order to minimize potential delays when the epidemic crisis ends.

SEE ALSO  The two factors that turned Google and Apple into tech giants

Genfit will continue the clinical research

Genfit’s diagnostic solution continues to be deployed in clinical research. Despite a high level of interest in NIS4, the use of the test may be curtailed due to potential delays encountered by some NIS4 clients as a result of the COVID-19 pandemic. The French biotech teams are moving forward in parallel with the In Vitro Diagnostic (IVD) part of the program.

Furthermore, Genfit does not anticipate any disruption in supplies for its ongoing or planned clinical trials at this stage. The Company has sufficient elafibranor inventory available for all of its clinical studies through mid-2021 and does not anticipate any disruption in raw material inventories or commercial batch production.

Similarly, its partners and teams have continuity plans in place to ensure the operational management of ongoing and planned trials, including under current conditions.

The FDA is the health authority in the US to grant market authorizations

Among the responsibilities of the Food and Drug Administration (the health authority in the United States) is the granting of marketing authorizations for all medicines intended for the United States, which represents the world’s largest market for the pharmaceutical industry.

Phase I refers to small-scale testing of the molecule in humans to evaluate its safety, tolerance, metabolic and pharmacological properties. Phase II refers to the evaluation of tolerance and efficacy in several hundred patients to identify side effects. Phase III represents the evaluation of the overall benefit/risk ratio in several thousand patients.

__

(Featured image by skeeze via Pixabay)

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.

This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.

First published in Capital, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.

Philip Gregg is a tech biz writer, with a keen understanding of blockchain technology, Internet of Things, and cloud services. He also serves as chief consultant for an IT business in Washington and a cryptowallet startup in Tokyo. Philip holds an MBA in finance and has previously worked at a Silicon Valley company before striking out on his own. He is a dad to three German Shepherds and owns a sweet vintage Mustang he fondly calls Sadie.