NASH is the acronym for nonalcoholic steatohepatitis. It’s a type of advanced liver disease that is clinically indistinguishable from alcohol-induced liver damage, but whose causes are totally different. Late stage NASH leads invariably to chronic cirrhosis and ultimately liver failure and death. The most common cause of NASH is long-term obesity, and so the threat has grown in relation to the rising rates of obesity in western society. Therefore NASH is quickly becoming an epidemic, with estimates of 15 to 30 million Americans living with the disease, the vast majority of whom are undiagnosed. They are living with a ticking time bomb inside their bodies. Continue reading “What is NASH?”
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.
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.
I do a lot of volunteer work with the American Liver Foundation. This frequently puts me in social settings at food & drink events where, upon hearing the name of the organization, I’m immediately confronted with the biggest stigma of Liver Disease. “Isn’t it a little odd to be talking about liver disease while holding a beer?”
I love these conversations, because the juxtaposition creates a teachable moment that is more likely than not to be remembered.
My response blows up their preconceptions. “Actually, there are over one-hundred types of liver disease that have nothing to do with alcohol. NASH is a serious progressive liver disease affecting over twenty million American’s alone”.Continue reading “The Stigma of Liver Disease”
One of the questions I see asked all of the time is what kind of testing is the best to determine if someone has NASH. I’ve written about the challenge of diagnosis before, but there are a lot of scared individuals out there trying to get answers from their under-educated primary case physicians, and everyone wants to skip the preliminary steps and go straight to a definitive diagnosis. If only it were that easy!Continue reading “The Best Diagnostic Tool for NASH”
For the 2nd International NASH Day yesterday I took part in a webinar along with Dr. Tuan Pham of the University of Utah. Dr. Pham gave a great overview of the latest in the NASH space and I shared the story of my mom to provide an advocate perspective.
You can view the video here:
I recently posted my American Liver Foundation Advocacy video where I told Mom’s tragic story. Along with myself, several other patients currently living with various stages of NASH plus several medical professionals took part in the advocacy campaign.
The videos are now all available on the ALF Youtube page. Below are the embedded Youtube Playlists. Watch and share!
For #NASHDAY I’m asking everyone I know to “Give It Up” for NASH Awareness. It could be sugar, coffee, alcohol, TV, politics…literally anything! Write about what you are giving up on the sign attached and share it all over social media next Wednesday June 12th to help spread the word.
And if you can take the $5 that would have gotten you a cup of coffee and instead donate it to the American Liver Foundation’s NASH Day page, you can help raise awareness, provide education and support, and help fund treatments for NASH patients in the future.
Hope to see you all Giving It Up on June 12th!
Visit https://alfmad.org/greaternewyork/support/#NASHday to donate.!
A few months ago I was honored to take part in an American Liver Foundation effort to educate and raise awareness for NASH. I travelled to University of San Diego’s Altman Clincial and Translational Research Institute where I recorded a video telling my mom’s story so that others could learn and benefit from our loss. I was joined by a panel of individuals currently living with various stages of NASH and a few distinquished medical experts in the field.
The videos are finally being released as part of our leadup to the 2nd International NASH Day on June 12th. You can watch the entire video below.
For #NASHDAY I’m asking everyone I know to “Give It Up” for NASH Awareness. It could be sugar, coffee, alcohol, TV…literally anything. Post about what you are giving up on social media to help spread the word. And if you can take the $5 that would have gotten you a cup of coffee and instead donate it to the American Liver Foundation’s NASH Day page, you can help raise awareness, provide education and support, and help fund treatments for NASH patients in the 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.Continue reading “Intercept Pharma announces successful Phase 3 NASH trials”
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.