You can add Madrigal Pharmaceuticals $MDGL to your list of NASH contenders — and a soaring share price this morning to underscore the blockbuster market it’s aiming at.
The key endpoints reported this morning center on the resolution of NASH, with 56% of the patients in the MGL-3196 group seeing a greater than two point reduction in their NAS score, compared to 32% in the placebo arm after 36 weeks. And among the 12-week responders the score was higher, at 70%.
NASH resolution was achieved in 27% of the drug arm and 39% of the early responders — clearly upbeat results for the biotech. In the placebo group, only 6% achieved NASH resolution.
Madrigal’s move into the NASH spotlight this morning was richly rewarded with a greater than 60% increase in their share price, what you might call a key unspecified primary endpoint not written into the protocol.
This trial showed a “correlation between MRI measure of liver fat at 12 weeks and biopsy NAS score at 36 weeks” – encouraging for the field looking for quicker, simpler, read-outs predictive of efficacy https://t.co/aBl49KWFMQ
— RxCelerate Limited (@RxCelerate) May 31, 2018
Rising obesity rates has made NASH a darling in the drug development crowd. Madrigal still has a long way to go, and it will get a closer inspection now at every turn of the process.
The principal investigator, Stephen Harrison, boasted:
Compared with Week 12, at Week 36 MGL-3196 showed sustained effects to reduce liver fat on MRI-PDFF, and more reduction in liver enzymes than placebo. MGL-3196 demonstrates improvement relative to placebo on measurements of NASH on liver biopsy, including resolution of NASH. Importantly, this study is the first to demonstrate a correlation between efficacy in a non-invasive imaging test, MRI-PDFF at 12 weeks, and improvement in NASH on liver biopsy at 36 weeks.
Image: Liver Shutterstock
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