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Posted On: 07/08/2024 3:01:09 PM
Post# of 148863
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more recent attempts to secure cash through “the issuance of debt, equity and other instruments” have been unsuccessful, the company said.
I can see why. The phase 2 trial is a bit of a mess.
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The study achieved the primary efficacy endpoint with an absolute reduction in Hemoglobin A1c (HbA1c) of 1.14% and 1.59% in patients with MASH and T2D treated with lanifibranor (800mg daily) or in combination with empagliflozin (10mg daily) at week 24 compared to an increase of 0.26% observed in the placebo arm.
https://www.biospace.com/article/releases/inv...sh-and-t2d
Which would show decreased glucose levels but would be more directly applicable to diabetes than NASH. Why they went with that as a primary endpoint is a mystery.
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The study also demonstrated a statistically significant reduction in hepatic steatosis measured by MRI-PDFF
Which is completely false. MRI-PDFF measures the level of liver fat not steatosis.
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Markers of liver inflammation and fibrosis (corrected T1 relaxation time (cT1) assessed by LiverMultiScan®) were assessed for the first time with lanifibranor and showed a significant effect with lanifibranor alone and in combination with empagliflozin.
This is the test that measures steatosis and it may show a significant effect but not a statistically significant effect.
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