Around this time last year there were a number of news articles declaring 2019 “The Year of NASH” . Four companies were due to release Phase 3 trial results. Optimism was surging and awareness was beginning to catch on. So how did 2019 turn out, and what does the outlook for NASH in 2020 look like?
A year later:
- Gilead had several Phase 3 studies end that failed to live up to expectations, eliminating Selonsertib as a serious treatment option
- Intercept released mixed results for Ocaliva, but is pushing ahead for FDA Approval. If granted, it would be the first approved NASH treatement. Decision on approval should come after April 2020.
- Abbvie (acquired Allergan) pushed their Phase 3 results for cenicriviroc from 2019 to late 2020.
- Genfit delayed Phase 3 elafibranor results to Q1 2020. It remains a promising undercard.
So while we didn’t get any truly amazing results for treatment in 2019, we did make progress. The 2nd International NASH Day helped reach people across the globe. Awareness has been steadily growing.
And while we have yet to hear from Genfit on their treatment data, they did recently announce tremendeous progress in their quest for a non-invasive diagnostic test. Using a unique 4-biomarker algorithm they have been able to accurately identify NASH and significant fibrosis. Genfit plans to file for FDA approval of the test in 2020.
A reliable non-invasive test for NASH is in some ways even more important than a medical treatment. The danger from NASH comes from years of undiagnosed progression, and we already know that the liver damage NASH can cause is reversible in earlier stages of the disease.