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 have a friend who once lost a whole bunch of weight by removing two simple things from his diet. Cheese and soda. This was well before the current Paleo diet craze, when sugary drink taxes weren’t even whispered in the most progressive of city councils. It was also well before I knew anything about the liver or the difference between sucrose and fructose in the sugar I consumed. His story always stuck with me, though I never realized why it had worked.
Ever since the untimely death of my mother from NASH, I have spent a lot of time learning about the underlying causes that likely led to her liver failure. Along the way, I had to reexamine a number of misconceptions and prejudicies I’ve had about health and eating. Whether from genetics or pure luck, I’ve been blessed all my life with never having to worry about weight or what I eat. I never put a lot of thought about what I was putting inside my body until i started to read research about how obesity and metabolic syndrome developed, and why we were suddenly facing a worsening crisis over the last 50 years.
What I’ve found has changed my entire view on food & health.
When my mom passed away at 62 years old six weeks after being diagnosed with a disease I’d never heard of before, it sent me searching for answers. NASH is still widely unknown and the etiology is not well understood. Yes, it is largely linked to obesity, but there are many other risk factors that seem to be playing a role. One such factor that I discovered last year was the link between hypothyroidism and NASH, which my mom had for decades.
Recently I have been working on some projects on how the liver works, and found myself intrigued when writing about the function of the gallbladder. For those that are unaware, its main function is storing bile to be used in the digestion of fats. As I wrote about it, alarm bells began ringing in my head. NASH is the end stage of fatty liver disease, caused by an excess buildup of fat in the liver.
Gallbladder surgery (known as cholecystectomy) is one of the most common surgical procedures in the world, with over 600,000 procedures performed annually in the USA. It is considered completely safe with no long-term negative effects. My mom had her gallbladder removed years ago after suffering gallstones, as is the standard medically recommended procedure. I wondered if there was any studies on possible links between it and NASH, and began searching.
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.
2018 was a big year for those trying to raise awareness of NASH, as well as those developing treatments and diagnostic methods. The first International NASH Day was held, a day of action with events in over a dozen cities on four continents.
2019 is already looking to be a major year for progress in the fight against NASH. Recently, Goldman Sachs declared that 2019 will be “The Year of NASH” based on the fact that several BioTech companies are expected to release late-stage trial results of promising treatments.
Tony is a NASH transplant survivor and the founder of the NASH Education Corporation, a Pittsburgh-based non-profit focusing on increasing awareness and providing educational materials for NASH. I’ve been wanting to write about patients living with NASH for quite some time and Tony was generous enough to agree to an interview for a profile piece, the first ever on NASH AWARE.
My mother passed away suddenly four years ago this month after a short battle with late-stage NASH. Which is impossible, but somehow true. Just a few days before being diagnosed with NASH she was celebrating with my wife and I at a housewarming party at the Shore. A picture of her from that party occupies a prominent place on our fridge; the last picture of her before our lives were all changed forever.