Summary
- Recently announced Q2'20 financial results and provided key updates on development timelines.
- Filed IND for VK0214 in X-ALD. Expect to commence Phase 1 dosing study in healthy volunteers.
- Continuing enrollment in VK2809 Phase 2b VOYAGE study. Investors may be underestimating the sentiment shift back towards liver fat reduction.
- Significant developments within the NASH market as multiple competitors and competing mechanisms of action have fallen by the wayside due to trial failures. Thyroid-beta agonist class remains unscathed.
- Company remains well-capitalized with over $260m of cash to fund operations through multiple data milestones.
Introduction
It’s closing in on almost 3-years since I first published my initial write-up on Viking Therapeutics (VKTX) back in Oct-2017. I’ve had plenty to say about the company since that time, publishing numerous other articles along the way, but more recently I’ve been quiet about it; and it’s actually almost a year-and-a-half since I last commented with “Year in Review” as a public update. COVID has had a funny way of distorting time and frankly, there just hasn’t been that much to add to the conversation since it entered a “data desert” after delivering positive Phase 2 results in late 2018. With its most recent Q2 earnings release behind it, along with plenty of other goings-on in the NASH landscape, it now finally feels like the right time to provide another update.
VK5211 / SARM
First though, I just want to take a minute to look back over Viking’s selective androgen receptor modulator (SARM) program, VK5211. I’m not sure whether it’s been formally/directly addressed in any of the various conference calls or analyst notes, so I’m just going to piece it all together right here in one place, because my initial report—Welcome to the Glorious House of Gains—laid claim to significant potential value for the molecule; and while I’d mentioned that VK2809/NASH was likely to be the molecule/market that most investors were most focused on (and for good reason), Viking’s SARM program was still front and center.
So, what happened? Because over 2-years removed from extremely positive Phase 2 data and after giving various presentations at conferences like ASBMR, etc. … there is essentially nothing to show for it.
The simplest way to explain what happened is that the game has changed. The FDA made it clear that an “approvable endpoint” for a Phase 3 trial would require showing a functional benefit, rather than just an increase in muscle mass. This makes it more challenging to design a trial with confidence since it becomes nearly impossible to account for the uncontrollable aspects of such things like a patient’s willpower to push forward, etc. Management had called out an important “dose-related improvement” in various functional endpoints (6-minute walk test, etc.) when it read out Phase 2 data – but to have a study be “powered” and reliant on those metrics from a standpoint of statistical significance is something quite different. You’re not just relying on the drug at that point – it’s also incorporating the qualitative aspect of who a patient is that can determine whether they perform a little weaker/stronger. This risk of an outsize “placebo effect” seemed to be what derailed GTx (formerly GTX) from showing statistical significance in their analogous trial of Enobosarm for women in stress urinary incontinence (NYSE:SUI). This aspect likely limited partner interest and effectively stifled progress, since the company committed to partnering the drug as the only path forward.
I’m not sure this type of standstill is what the FDA had in mind as a goal, since nothing else to date about the drug’s efficacy profile and/or the significant unmet need to address that hip fracture indication/medical outcome in the elderly population has changed… but yet, here we are. Similar to the “can’t fight the Fed” mantra… it seems the FDA works in a similar manner. Progress for the molecule was effectively halted; and the path to higher value along with it.
