In a widely anticipated clinical trial in the blockbuster GLP class, Viking Therapeutics (VKTX) released excellent Phase I data for Oral ‘2735 at 28 days in obese patients, observes John McCamant, editor of The Medical Technology Stock Letter.
The company reported both excellent efficacy of 5.3% weight loss at the highest dose in just one month along with a clean safety profile. Despite the small trial size, VKTX was able to demonstrate dose-dependent and statistical significance at the top dose of 40mg vs. a placebo group which performed unusually well, with no signs of plateau at the highest dose tested.
Importantly, the safety profile was very good, with all GI events mild or moderate and no difference in overall GI tolerability between oral VK2735 and placebo.
Based on these promising initial results, VKTX will continue dose escalation in this trial, starting patients at the 40mg dose and could go as high as 60-90mg or higher depending on safety/tolerability. At first glance, Viking may have another Best-In-Class oral GLP to go with its potential Best-In-Class injectable one.
VK2735 showed a classic and imposing dose response even in this small trial. We are particularly encouraged by the safety profile, as all TEAEs appear to be mild and moderate and only a low rate of common GI AEs (like nausea and diarrhea), with no vomiting or constipation observed and no difference in overall GI tolerability between oral VK2735 and placebo.
The impressive safety data — which is critical for a potentially chronic use pill where A/Es but not lack of efficacy lead to discontinuation — further supports dose-escalation of oral ‘2735 that VKTX is currently conducting, and VKTX plans to start the first dose at 40mg for the additional cohorts. This is excellent news for the potential best in class drug as we may see even better efficacy at higher doses.
In our view, the top line Phase I oral data exceeded all expectations and reinforces the best-in-class potential for VK2735. This is particularly encouraging after market leader Novo Nordisk (NVO) recently cherry-picked a small data cohort to announce positive results from the first trial of its own oral GLP version.
We have been excited to see the oral VKTX data ever since the subQ version of the same drug significantly exceeded expectations in Phase II with a 14.7% weight loss after 13 weeks.
VKTX is planning to start a Phase II trial for oral ‘2735 in 2H24 (IND planned for mid-year), which could mirror the development of the subQ ‘2735 Phase II development program with additional titration/doses tested.
With a potential best in class drug for oral and injectable use, VKTX has to be on many Big Pharma/Bio acquisition wish lists as the company represents a very scarce asset in the $100 billion market for weight loss drugs. VKTX is a buy under $100 with a target price of $145.
