Biotech Values

[Mufaso]

Whaltane- Regarding the VK2809 placebo response in Viking’s 2a study from 2018 , I thought I would comment on this separately. At 12 weeks for the metric of participants who achieved greater than 30% reduction in liver fat, the response was 18.8% in the placebo arm. This compared to the dosed arms where 83.3% had a reduction of greater than 30% of liver fat. (p=<0.01).

I’m not unduly concerned by this seemly high placebo response. The VK2809 2a Study was small (N=14 in the placebo arm) so one patient responder made a big difference. Others including ENTB and MDGL have had low double digit % placebo responses.

There is other data that is more meaningful to me. There was an EASL presentation from 2020 (the 2020 data you were referring to?) that presented on VK2809 16-week data after dosing stopped at 12 weeks. Below are some quotes from the Viking 4th Q 2020 press release. I bolded some things that were particularly interesting that suggest to me that VK2809 will be successful in NASH:

Additionally, at Week 16, 70.4% of all VK2809-treated patients maintained a response, defined as experiencing ≥ 30% relative reduction from baseline in liver fat content (p=0.0083). Of note, 100% of patients receiving 5 mg daily doses of VK2809 demonstrated a response at Week 16.

The presentation also highlighted additional Week 12 results that demonstrated significant reductions in liver fat content among patients receiving VK2809 as compared to placebo regardless of the presence of common risk factors for NASH, including baseline levels of alanine aminotransferase (ALT) above the upper limit of normal (ALT > xULN), body mass index (BMI) ≥ 30, hypertension and Hispanic ethnicity.