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EnergyFundies

03/13/24 9:14 PM

#251078 RE: herculian #251068

NASH should be imminent. 12-week results were in May 2023. 40 weeks from then is basically now.
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Mufaso

03/17/24 5:47 PM

#251096 RE: herculian #251068

Vk2809 readout timing- The only thing VKTX management has said is 1st half 2024 but I previously commented on this in #msg-173767903:

Viking also should be working to finalize 52 week biospy confirmed fibrosis data on their NASH compound VK2809. They completed enrollment on that study Jan 9th, 2023, so 52 week dosing should have been completed on that study already with data being analyzed now. Management again conservatively guided to the NASH data being read out 1st half 2024. (Early 2nd q is likely though)


Since I posted that message, Brian Lian said this in the 4th q CC Feb 7th:

Thomas Smith
... And then maybe just one on VOYAGE. You mentioned having just completed the last patient biopsies recently. Maybe you could just remind us how you're thinking about evaluating those biopsies in VOYAGE, whether you're using a single pathologist or multipath review and just kind of walk us through the gating factors there to reporting the top line data set.

Brian Lian
Yes. Thanks. So the biopsies are the slower element there. It is a single reader that we're using. And the single reader goes to a second reader when there's a patient whose biopsy is right on the cusp of something like F2 or F3 fibrosis or an NAFLD activity score of 4, things like that go to a second reader. And then the first and second reader must reach a consensus before the final assessment of the slide is made.
So I think we started the study really before the 3 reader approach had become more widely used. And so that's why we have the single reader.


So Brian confirmed the study completed dosing in January 2024 and is saying the data evaluation is taking some time because they used the single reader approach to biopsy evaluation and some biopsies on the cusp of a fibrosis stage or NAFLD threshold score for steatosis/inflammation. Given that the study completed dosing in Jan 9th, add 16 weeks for analysis as a wag and you would get Tuesday April 30th as my guess. Could be earlier or later though.