Thanks KBC - It was a good reminder of what transpired back then regarding safety. RVX-208 was attacked regarding danger to the liver. RVX was not concerned as they felt there should be some effect if plaque was being removed and sent to the liver but they had no worry since there was not bilirubin found. I remember DM stating that they would almost be disappointed had there been no ALT rise as it wasn't necessarily bad, just a marker that there was a change and they were hoping to change by sending more plaque to the liver.
From the webcast that KBC posted the link to, below shows there opinion of the effect on the liver as found in their analysis.
Slide Twenty Three shows the strong safety profile that we’ve previously shown, with very few reactions and 97.9% of all patients completing the trial, with no Hy’s Law and no negative liver results that we’re aware of.
Slide Twenty Four
And on slide Twenty Four, this shows again the frequency of the ALTs that we’ve seen in the past, where they come between usually weeks six and twelve, they’re benign, they go away. And there’s no signs of any liver results at all. And beyond week twelve, as in previous trials, we see nothing at all. So it’s an early marker but it goes away quite fast. Now we’re not concerned about it, and we’ll show that in slide Twenty Five.
Slide Twenty Five
This slide compares RVX to other ALT related drugs, and it confirms our safety belief. This slide depicts marketed and approved drugs that show ALT recovery times that are five to seven times longer than RVX-208, again confirming a very benign ALT effect.