New medicine for NASH????

[sosteady]

Has anyone here heard anything of the trial by Intercept Pharmaceutical? Were you impressed with the results? This is the first paragraph from the article in the Boston Globe:

Intercept Pharmaceuticals said Thursday that an extensive re-analysis of a large clinical trial involving its experimental treatment for the fatty liver disease known as NASH once again achieved its primary efficacy goal.

[NYLassie]

I have been participating in the study for about 4 years. As it is a double blind study, I don't know if I am taking the drug or the placebo. I don't know whwt is considered statistically significant but in just over 22% of thode taking 25 mg of OCA in the study, liver fibrosis was reduced by at least one grade. The study is ongoing hmmm snother 3 years, if I remembermrmber correctly. The FDA has moved the goalposts a few times, stating that they question the benefit of an improvement in fibrosis. That seems mad to me, as it is fibrosis that leads to dire outcomes.

[sosteady in reply to NYLassie]

When I read the article I was sure folks from our group here had participated. It makes me believe their actually is some progress. That seems really odd to me too. Reduced fibrosis is one of the goals. Thank you for your reply.

[Troutwhisperer in reply to NYLassie]

I absolutely agree with your response! Stop moving the goalposts !

Best Wishes,

Troutwhisperer

[KC108]

Resmetirom by Madrigual Pharma is getting close to file for approval and looks like it might be the first drug approved for NASH. Phase 3 data was just released. You can google it and get information on it,

[sosteady in reply to KC108]

I have read loads more thank you for the information. It does not sound as fabulous as I originally thought, nothing will beat a liver friendly diet and exercise. Please take care of yourself.

[Cats2018 in reply to KC108]

I’m currently in the 2nd year of phase 3 clinical trial for Resmetirom with Madrigal Pharmaceuticals. The 1st year I didn’t know if I was on placebo or the drug. I consented to a 2nd year with Madrigal in which I was guaranteed to be on Resmetirom. I take 100mg daily.

[KC108 in reply to Cats2018]

I hope you have hreat results!

[Troutwhisperer in reply to Cats2018]

This also is great news. A real possibility of significantly affecting the health of your liver! Please continue to share any news, I am smiling big time for you right now.

Best Wishes,

Troutwhisperer

[Troutwhisperer in reply to KC108]

Great news! Thanks for sharing!

Best Wishes,

Troutwhisperer

[Jmaxley]

I started in the OCA study in the fall of 2018, after being diagnosed in 2017 with nonalcoholic cirrhosis. After 8 months on the study, I developed varices of the stomach and esophagus, so they sadly took me off it the study. Staff at the medical center who monitored me for the study said they pretty well determined that I was on the actual drug because in those 8 months I had to be medicated for severe pruritus (itching), which is a common side effect of the drug. I had to have another liver biopsy and the extensive testing when I came off the trial, and at that point, I showed no improvement in fibrosis. I continue to be monitored by them and appear to be holding my own, so I wonder the residual effects did help some. However, I continue to have some low grade varices.

[sosteady in reply to Jmaxley]

Sounds severe, I think when I read the article I felt excited and pleased that research was underway. Now that I have read more articles and gotten more information I’m inclined to continue to focus on the big 3….a liver friendly diet, exercise and rest. I was momentarily dazzled into thinking a magic pill would fix everything. Thank you for your participation and your response to my inquiry. Please take care of yourself.

[Jmaxley in reply to sosteady]

Thank you. I’m glad I could give you an insight into my experience with the trial and drug. You take care also!

[Troutwhisperer in reply to Jmaxley]

Thank you for sharing. Stay positive as new alternatives I believe are in all of our future. Until I read or here something negative about the supplements I have been taking for many years I suggest milk thistle, phosphytidyl choline, vitamin E, & extra virgin olive oil. My fatty liver disease with a diagnosis of NASH Stage 0-1 hopefully suggests I’m doing ok. First diagnosed with fatty liver disease in 1986.

Best Wishes,

Troutwhisperer

[sosteady]

Excellent results! thank you for sharing

[Troutwhisperer]

Thank you for sharing. Hopefully the FLF agrees with members voicing their opinions here regarding Intercept Pharmaceuticals and their most recent positive results. We need the FDA to move forward with approval please.

Best Wishes,

Troutwhisperer