Biotech Values

[Mufaso]

VKTX-Top line VK2809 12-week results will only be for liver fat content as assessed by MRI-PDFF. Fibrosis won't be assessed by biopsy until 52 weeks:

The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter, international trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. Enrollment included patients with at least 8% liver fat content as measured by magnetic resonance imaging proton density fat fraction, as well as F2 and F3 fibrosis. The study allowed for up to 25% of enrolled patients to have F1 fibrosis provided that they also possess at least one additional risk factor, such as diabetes, obesity or hypertension, among others. The primary endpoint of the study will evaluate the change in liver fat content from baseline to Week 12 in patients treated with VK2809 as compared to patients receiving placebo. Secondary objectives include the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment.

I have confidence that the 12-month results will lead to a share price increase. While this trial studying a tougher population than the 2A trial (all participants are NASH confirmed via biopsy), I expect results for fat reduction to be very good and similar to the 2A study. Safety and fat reduction characteristics of this drug have already largely been answered.

The 12-month results will answer the fibrosis question which hasn't been proven by the "gold standard" biopsy test. Also, because VK2809 is a prodrug- there has been a concern about CYP3A down regulation and this will also require the 52-week time frame to answer.

So the 12-week results in my view are less risky to share price as there is less that can go wrong and the prior data on what is being reported strongly suggest the 12-week results will be positive.