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Re: Whalatane post# 215837

Friday, 12/08/2017 11:35:40 PM

Friday, December 08, 2017 11:35:40 PM

Post# of 253168
VKTX/MDGL -

Titan. I read a P1 trial for VK2809 ...56 patients with mild hyper cholesterol.
Of these 56 ...10 of them developed asymptomatic elevations of Liver enzymes ...mostly elevated ALT at the higher doses .
Elevated ALT levels indicate that the Liver cells are inflamed and damaged with the risk over time ,of losing function .
IMHO its very unlikely this drug will ever be used by Hetero Familia Hypercholestremia patients as most of us are on high intensity statins and vulnerable to elevated ALT levels already.

This is not a comment on VKTX's potential for treating NASH .
I'm not an MD so those on this board who are , might have a different view
.

I think this is the PR from VKTX regarding the P1 trial of VK2809 you're referring to: http://ir.vikingtherapeutics.com/2016-11-15-Viking-Therapeutics-Presents-New-Clinical-Data-on-VK2809-in-Subjects-with-Elevated-Cholesterol-at-American-Heart-Association-Scientific-Sessions-2016 .

In particular, I found the following quote interesting: "Consistent with liver-targeted thyroid receptor activation, mild, asymptomatic elevations in liver enzymes and decreased thyroid hormone levels were observed at higher doses."

So, if a class effect, why is it that the MDGL drug did not raise liver enzymes in the P2 trial and, in fact, led to statistically significant reductions at higher doses? It would seem to me that the MDGL drug may be differentiated from the VKTX drug on this front. Note: the class effect reference seems to imply the indication (whether NASH or HeFH trial) or length of the trial (I get this was just 14-day VKTX trial vs. 12 week trial in NASH for MDGL) might not matter.
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