VK5211 Phase 2 Results Presented at ASBMR 2018 Annual Meeting
On October 1, 2018, Viking Therapeutics, Inc. (NASDAQ:VKTX) announced that results from the Phase 2 clinical trial of VK5211 in patients with hip fracture were presented at the 2018 American Society for Bone and Mineral Research (ASBMR) Annual Meeting. This was a multicenter, randomized, double blind, placebo controlled trial that enrolled a total of 108 subjects (83 women and 25 men) age ≥ 65 years of age who have suffered a hip fracture within the past three to seven weeks. Subjects were administered placebo or 0.5 mg, 1.0 mg, or 2.0 mg of VK5211 once-daily for 12 weeks (NCT02578095). The primary outcome of the trial was the change in lean body mass, less head, after 12 weeks of treatment. Secondary and exploratory endpoints included assessments of functional performance, quality-of-life, and activities of daily living. The following slide gives a breakdown of the demographics for the trial.
The company had previously reported that the study achieved the primary endpoint by demonstrating a statistically significant increase in lean body mass, less head, in those administered VK5211 compared to placebo (see below left). Additional data presented at the meeting included 24-week follow-up data after study subjects had been off treatment for 12 weeks (see below right). The data showed that increases in lean body mass, less head, for all subjects administered VK5211 remained above placebo even after treatment was stopped, demonstrating the potency of VK5211 activity.
This increase in lean body mass, less head, was accompanied by a dose-dependent increase in body weight and a dose-dependent decrease in fat mass. This shift in body composition is an impressive result, as previous studies have shown that in the first year after a hip fracture, fat mass increases by up to 7% (Karlsson et al., 1996) while lean mass decreases by up to 11% (Fox et al., 2000). This is in comparison to healthy older females who lose approximately 1% of lean mass per year and gain approximately 1.7% in fat mass (Karlsson et al., 2000).
Some of the new data presented at ASBMR showed that there were dose-dependent increases in the 6-minute walk test (6MWT) for those taking VK5211, with a greater than 20-meter improvement at the highest dose compared to placebo. As a reminder, this outcome was not powered to show statistical significance, however the dose-dependent increase is encouraging as the 6MWT could be a clinical outcome for a Phase 3 study.
The following slide gives an overview of the adverse event profile for VK5211. Importantly, there were no drug-related serious adverse events reported, no significant differences in the rates of adverse events when comparing VK5211 and placebo, and there were no dose-dependent differences in the number of adverse events when comparing the different VK5211 groups.
In addition to there being no drug-related serious adverse events reported, there were also no clinically meaningful changes in such markers as red blood cell count, hemoglobin, or serum lipids, as shown in the following table.
The data presented on the Phase 2 trial of VK5211 further increases our confidence in the company’s ability to find a suitable partner to continue development of the drug into Phase 3. VK5211 treatment results in impressive changes in body composition that is in stark contrast to what typically occurs in a hip fracture patient population. In addition, the 6MWT results showed a favorable trend toward treatment. Based on these results we have increased the probability of approval for VK5211 to 70% and increased potential peak worldwide sales to $2 billion. This has increased our valuation for Viking to $28 per share. Following the big jump in the stock price after release of the VK2809 Phase 2 data the stock has pulled back somewhat. We would look for any weakness in the stock as a buying opportunity as we consider Viking one of our top picks among small-cap biotech stocks.
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