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”→
The impact of NASH is only starting to be realized. One sobering figure just released by the CDC highlights yet another trend going in the wrong direction. From 2000 to 2016, the mortality rate for liver cancer rose 43%, even while the rates for all other cancers declined.
On the heels of competitor Madrigal’s excellent trial results another small BioPharma company has released phase 2 results that sent their company stock skyrocketing. Galmed Pharmaceuticals, a small Israeli biopharmaceutical company, produced statistically significant results with a drug called Aramchol in the lowering of fat in the liver at 52 weeks. The analysis of the results was embraced by the markets, which sent the stock soaring 250%.
In one endpoint, more patients treated with 600 mg of Aramchol versus placebo achieved NASH resolution without worsening of fibrosis, at 16.7% versus 5.0% (p=0.0514), respectively, as well as NASH resolution more generally, at 19.2% compared to 7.5% (p=0.0462). In addition, the second biopsy endpoint showed a higher proportion of patients with at least a one-point improvement in fibrosis score without worsening of NASH.
We are at an exciting time for NASH treatment options with multiple companies pursuing promising candidates. People suffering from NASH will still require significant lifestyle changes but hearing about more successful trial results is a very positive step towards getting a grip on the pandemic.