The FDA’s response stated the “predicted benefit of OCA…remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.” In a sign that there may be future hopes of approval, they suggested that Intercept “submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study…and that the long-term outcomes phase of the study should continue.”
So essentially there is no chance of FDA approval for OCA in 2020, but it potentially could still see a reprieve sometime in 2021 or beyond. This has investors running for the exits (stock is currently down 40% today), as the biggest advantage Intercept had was that it would have been the first approved treatment. The actual Phase 3 results were largely unimpressive, especially compared to other drugs in development, but any treatment is better than no treatment. By the time OCA eventually does receive approval, competitors with better treatments may already have beaten them.
In any case, the search for a treatment for NASH goes on. In the meantime, we can all search for ways to make lifestyle changes and eat healthier.
Last night French biotech company Genfit released the results of their widely anticipated Phase III study on Elafibranor, a NASH therapeutic that had shown tremendous promise in earlier trials.
Unfortunately, the trial failed to meet both the primary and secondary endpoints. The treated patients response wasn’t statistically meaningful versus the placebo control group. Genfit’s CEO Pascal Prigent said “These results are highly disappointing.” The stock is down by over 65% today.
This setback leaves us with just Abbvie’s cenicriviroc study to look forward to this year, due in late 2020 if there are no delays due to the Covid crisis. Intercept’s Ocaliva is due for FDA approval soon, but seems to have limited effectiveness in specific NASH cases.
The best treatment for NASH and NAFLD remains a healthy diet and lifetsytle changes for the foreseeable future.
Will move for approval in US and Europe later this year
Eagerly awaited Phase 3 trial results were released early Tuesday morning from Intercept Pharmaceuticals, showing positive results for the study’s primary goal of showing a statistically significant reduction in liver fibrosis compared to placebo. As a result, Intercept will seek approval in the US and Europe to permit the drug, known as Ocaliva, to be used as the first ever treatment for NASH-related fibrosis. The stock price rose as high as 23% on the news.
I’ve written before about how weight management might be a lot more about what is happening in your gut than whatever diet of the month you are trying. This is one reason why bariatric surgery may be the most effective long-term weight loss solution available; it changes and restores the makeup of gut microbiota.
One of the most difficult challenges with NASH is that it is so difficult to diagnose. While many Biotech companies are working hard to develop a cure for NASH, some are also busy developing new innovative methods to detect NASH without requiring an invasive liver biopsy.
Genfit is one of the few companies due to release Phase 3 trials of NASH treatments in 2019. Not content with focusing merely on a cure, they are also nearing completion of trials on a new blood test for earlier detection of NASH. They have just recently announced a partnership with LabCorp, which will allow them access to a much wider audience for the clinical research required to validate the new test.
A new study from New York Presbyterian Hospital has some eyebrow-raising findings. We already know that drinking coffee is good for the liver, but you would expect to find less evidence of a positive relationship with alcohol. Yes, there have been plenty of studies that show a glass of wine can be good for you, but never one that highlighted an actual positive link.
I lost my mother suddenly to late-stage NASH when she was only 62 years old. The search for answers and meaning has led me to working with the American Liver Foundation and starting this blog. One thing that has become increasingly clear to me was that my mom’s decades of hypothyroidism could have been a major cause of her progression to NASH. Now, a new meta-study examining 18 years of data has concluded that those patients with primary hypothyroidism are at a 42% increased risk for developing NAFLD, the precursor to NASH. Continue reading “The Thyroid’s link to NASH”→
One of the coolest things about the liver is that it is the only major organ capable of regenerating itself. In fact, during a living donor liver transplant, as little as 1/3 of the living donor’s liver is transplanted and grows back to full size in the recipient within only a few weeks time. When you think about it, this makes perfect sense. The liver’s job is to detoxify our bodies, which means that they are constantly processing toxins that would otherwise kill us. Whether it is alcohol, drugs, or simple byproducts of food that we ingest, the liver has to be able to handle removing them from our bloodstream to keep us healthy. Continue reading “New treatment restarts liver regeneration”→