Important news, Madrigal releases phase 3 biopsy results for Resmetirom, much better than expected, fast track to FDA

[nash2]

drive.google.com/file/d/1Mw...

[Liver007123]

would this help in Cirrhosis secondary to NASH or only if it hasn’t got to the Cirrhosis stage ?

[nash2 Partner in reply to Liver007123]

cirrhosis and stage 4 NASH are the same thing so it improves fibrosis but we don't know yet what patient group the FDA might consider approval for.

[Liver007123 in reply to nash2]

Well

It’s fantastic news hopefully lots of people will benefit from it in the future 😊

[isi123]

I understand that it will improve the liver health of all those who have metabolic problems with fatty liver, even if their primary disease is not NASH.

[nash2 Partner in reply to isi123]

It does have some general metabolic properties as it is a modified thyroid hormone actually

[Livmar]

Great news Wayne! Hopefully the FDA will approve for all levels of fibrosis 🙏. Keeping fingers crossed 🤞.

[Robert1220]

Fantastic news for sufferers of stage 4 fibrosis NASH of which I'm one.

[Alterity]

I haven't heard anything more from Chris, he was going to call me in June. I'm starting a new study in a couple weeks with Semaglutide and another drug. Looking at how the weightloss drug effects NASH. This is my 2nd research program. I look forward to someone getting a cure.

[Robboref]

Hi nash2, I’m on the trial here in the UK. Obviously I don’t know if I’m on drug or placebo as it’s double blinded but I feel great and the clinic are so thorough. I’m 2 years into the 4 year trial so my fingers are crossed for all my fellow Nash patients for a hopeful future.

[Cats2018]

Hi Wayne - I recently completed my 2nd year in the Madrigal Clinical trials for Resmetirom. The 1st year I didn’t know if I was on Resmetirom or placebo. I consented to a 2nd year in the phase 3 trial with guarantee of being on Resmetirom. For the 1st 3 months of the 2nd year I was on 80mg Resmetirom and for the remaining 9 months I was on the high dose of 100mg through November 14, 2022. My initial FibroScan in 2018 when diagnosed with Nash F3 my results were CAP 400 and kPa 11.7. (On another scan in that time frame the kPa was 14). After my 1st year on the Madrigal trial when I may have been on the Resmetirom but possibly on placebo my FibroScan was CAP 233 and kPa 11.9. That was Oct 2021. At end of my year on Resmetirom my November 2022 FibroScan was CAP 236 and kPa 6.4. Needless to say, I was disappointed at no longer being able to remain on Resmetirom. The trial was extended but only for cirrhosis patients so we participants with NASH were excluded from continuing. I was extremely pleased with the results at the end of my participation in the Madrigal phase 3 trial.

Char

[nash2 Partner]

Hi Cats, Thanks for the great report. That is good progress and about what we expect from the drug. A kPa of 6.4 normally means no fibrosis. The goal we all seek. Fantastic,

[Livmar]

Hi Wayne, My understanding was the Resmetirom drug was only to be used for up to Stage 3 Fibrosis and not cirrhosis? Did I misunderstand their trial info ? From the news..."Madrigal intends to file a new drug application seeking accelerated approval of resmetirom for the treatment of non-cirrhotic NASH with liver fibrosis". ir.madrigalpharma.com/news-.... Thanks

[nash2 Partner]

I believe that is correct. It is not an F4 treatment under the current trial design.

[Livmar in reply to nash2]

Thanks