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Biotech / Medical : Madrigal Pharmaceuticals
MDGL 418.90-2.0%Oct 31 9:30 AM EST
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To: Miljenko Zuanic who wrote (106)7/19/2019 11:51:59 AM
From: tuck  Read Replies (1) of 138
 
Two new updates to the P3 clinical trial. One is a name - "MAESTRO-NASH" - although that s definitely old news. More significantly, they are adding another secondary outcome measure:

>> Other Pre-specified Outcome Measures:
5.To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with stage 1 fibrosis
Assessment will be in stage 1 fibrosis patients and be based on the proportion of MGL-3196 80 mg or 100 mg treated patients relative to placebo achieving NASH resolution (NASH Activity Score (NAS), ballooning =0; lobular inflammation =0,1) with at least a 2 point reduction in NAS and no worsening of fibrosis. <<

I can't remember if they discussed adding stage 1 patients before. If not, what does this imply, aside from trying to expand the market some? Less power in the stage 2-3 cohorts if enrollment numbers aren't bumped up? Because the target enrollment is unchanged.

Hmmm.

Cheers, Tuck
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