Could a Diagnostic Be Key to Winning This Big Healthcare Market?

TL;DR

Genfit, a smaller biotech company, is developing a late-stage Phase III candidate, Elafibranor, for the treatment of NASH, a major cause of liver transplants. They also have a diagnostic tool that could help diagnose NASH earlier.

Transcript

Shannon Jones: Todd, you recently had the unique opportunity to interview a member of the executive team of a smaller biotech that over the past few years has caught a tremendous amount of attention from biotech investors. That company is Genfit, ticker GNFT. Genfit best known for its late-stage Phase III candidate Elafibranor, which is being studi... Read More

Key Insights

• 😷 NASH has become a major concern in the medical field due to its increasing prevalence and lack of approved treatments.
• 👻 Genfit's diagnostic tool for NASH could be a game-changer by allowing for early detection and intervention.
• 🐎 The race to develop an effective NASH treatment involves multiple companies with different mechanisms of action.
• 🎨 Genfit's Phase II trial for Elafibranor did not meet its primary endpoint, but the company has made adjustments in study design for their Phase III trial.
• 🚚 The results of Genfit's Phase II trial in another liver disease indication, PBC, could have implications for the success of their NASH treatment.

Questions & Answers

Q: How has the success of Gilead Sciences in hepatitis C influenced the research on NASH?

Gilead Sciences' success in hepatitis C has drawn researchers' attention to liver diseases, leading to increased focus on NASH as a major cause of liver transplants. Researchers believe that finding a treatment for NASH could be the next big breakthrough in the field.

Q: What competitive advantage does Genfit have over other companies in the NASH market?

Genfit's competitive advantage lies in its diagnostic tool. Unlike other companies that primarily focus on developing drugs for NASH, Genfit has also developed a low-cost blood test to diagnose NASH earlier. This could allow for earlier intervention and treatment.

Q: How are Phase II trials helping companies like Genfit in developing their NASH drugs?

Phase II trials for NASH drugs are exploratory in nature and help companies identify the best mechanisms of action for their drugs. Each company is targeting a slightly different mechanism, and these trials help in refining their approach for Phase III trials.

Q: What are the key things to watch for in Genfit's Phase III trial for Elafibranor?

It will be crucial to see if Genfit's Phase III trial for Elafibranor meets its primary endpoint. Additionally, the interim data expected at the end of 2019 will provide insight into the drug's potential for FDA approval. Comparing the results with other companies' trials will also be important to assess their efficacy.

Summary & Key Takeaways

• Genfit is a biotech company that has gained attention for its late-stage Phase III candidate Elafibranor, which aims to treat NASH, a disease becoming a major cause of liver transplants.

• NASH is a silent disease that is often not diagnosed until it has advanced. Genfit is developing a diagnostic tool that uses biomarkers to identify NASH earlier.

• Genfit's diagnostic tool is drug-agnostic and could be used with other companies' NASH treatments. They plan to roll out the diagnostic test in different research facilities next year.