Blog Exposure – Viking Therapeutics Reports Positive Top-Line Results from Phase-2 Study of VK5211 in Patients Recovering from Hip Fracture

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LONDON, UK / ACCESSWIRE / November 30, 2017 / Active-Investors issued a free report on Viking Therapeutics, Inc. (NASDAQ: VKTX), which is readily accessible upon registration at www.active-investors.com/registration-sg/?symbol=VKTX as the Company’s latest news hit the wire. On November 28, 2017, the Company shared positive results from its Phase-2 clinical trial of VK5211 in patients who recently suffered a hip fracture. Sign up now for our free research reports at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Viking Therapeutics most recent news is on our radar and we have decided to include it on our blog post. Today’s free coverage is available at:

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The study met its primary endpoint of a statistically significant increase in lean body mass, less head, compared to placebo. The study also accomplished its key secondary endpoints while no drug-related serious adverse events were observed.

About VK5211

Vikings’ lead program for muscle and bone disorders, VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM). It has been specifically designed to stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate.

At present, VK5211 is in its Phase-2 development for the treatment of patients recovering from non-elective hip fracture surgery.

It has the potential to produce the benefits of testosterone with better safety, tolerability, and patient acceptance because of its tissue-selective mechanism of action and an oral route of administration.

In the Phase-1 clinical trials, VK5211 exhibited statistically significant increases in lean body mass among treated subjects, after 21 days of treatment. Moreover, it showed improvements in bone mineral density, bone mineral content, bone strength, and other measures in a preclinical model of osteoporosis.

About the Phase-2 Clinical Trial

The Phase-2 clinical trial was a randomized, double blind, placebo-controlled, parallel group, international study designed to measure the efficacy, safety, and tolerability of VK5211 in patients recovering from hip fracture surgery.

The trial randomized a total of 108 patients to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks.

Viking Therapeutics plans to present additional results from the Phase-2 study at an upcoming scientific conference.

Top-Line Results for the Trial

The top-line results for the Phase-2 trial are as follows:

All doses of VK5211 showed statistically significant increases in total lean body mass, less head, which was the study’s primary endpoint. Placebo-adjusted increases in lean body mass were 4.8% at 0.5 mg; 7.2% at 1.0 mg; and 9.1% at 2.0 mg. These matched placebo-adjusted increases of 1.6 kg at 0.5 mg and 2.5 kg at 1.0 mg.

About 19% patients experienced at least a 5% increase in total lean body mass, less head with placebo, 61% at 0.5 mg; 65% at 1.0 mg; and 75% at 2.0 mg (p < 0.01 for each). And around 14% patients demonstrated at least a 2.0 kg gain in total lean body mass, less head with placebo, 57% at 0.5 mg and 65% at 1.0 mg ; and 81% at 2.0 mg.

Moreover, all doses of VK5211 produced statistically significant increases in appendicular lean body mass, which was the secondary efficacy endpoint. Placebo-adjusted increases in appendicular lean body mass were 6.1% at 0.5 mg; 9.0% at 1.0 mg; and 10.2% at 2.0 mg. These were in-line with the placebo-adjusted increases of 0.8 kg at 0.5 mg; 1.3 kg at 1.0 mg; and 1.4 kg at 2.0 mg.

All doses of VK5211 produced statistically significant increases in total lean body mass, including head, which was the other secondary efficacy endpoint. Placebo-adjusted increases in lean body mass were 4.7% at 0.5 mg; 6.8% at 1.0 mg; and 8.3% at 2.0 mg. These corresponded to placebo-adjusted increases of 1.7 kg at 0.5 mg; 2.6 kg at 1.0 mg; and 3.1 kg at 2.0 mg.

Besides, patients who were given VK5211 showed numerical improvements in exploratory assessments of functional performance, including the 6-minute walk test and short physical performance battery, compared to placebo. However, these endpoints were not powered for significance and further evaluation of exploratory functional endpoints is underway.

In fact, no major differences were noted in the rates of adverse events reported by patients receiving VK5211 compared to placebo. There were no dose-related differences in adverse events reported by various VK5211 treatment groups. And, no drug-related SAEs were observed in patients receiving VK5211.

An Important Advancement for Hip Fracture Patients

Jay Magaziner, PhD, MSHyg, Professor and Chair of the Department of Epidemiology and Public Health at the University of Maryland School of Medicine, stated that VK5211 has led to an impressive improvement in lean body mass in this group of older persons, who are prone to losing muscle. Since VK5211 can be taken easily and safely soon after hip fracture, it would prove to be a valuable addition to other therapeutic treatments such as physical therapy and a protein-rich diet to boost patients’ chances of resuming usual activities.

Stock Performance Snapshot

November 29, 2017 – At Wednesday’s closing bell, Viking Therapeutics’s stock declined 4.26%, ending the trading session at $2.70.

Volume traded for the day: 412.86 thousand shares.

Stock performance in the last month – up 15.88%; previous three-month period – up 147.71%; past twelve-month period – up 141.07%; and year-to-date – up 126.89%

After yesterday’s close, Viking Therapeutics’s market cap was at $72.95 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.3% at the end of the session.

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