Viking Therapeutics (VKTX) Announces Presentation of Positive VK5211 Phase 1 Data in Muscle and Bone Disorders

September 1, 2016 7:32 AM EDT

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Viking Therapeutics, Inc. (Nasdaq: VKTX) announced the presentation of data from a Phase 1 trial of VK5211, the company's lead program for muscle and bone disorders, at the 5th Fragility Fracture Network (FFN) Global Congress 2016, currently underway in Rome, Italy. The results of this study showed VK5211 to be safe, well tolerated, and to have a predictable pharmacokinetic (PK) profile in healthy women and men age 65 and over. Also during the conference, the company will make an oral presentation highlighting its ongoing Phase 2 study of VK5211 in patients recovering from non-elective hip fracture surgery. FFN organizers have designated Viking's VK5211 Phase 2 study design as one of the conference's top 15 poster presentations and will feature it as part of an oral plenary poster presentation session on September 2.

VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate. The company believes these characteristics may provide important benefits to patients recovering from hip fracture.

"We are pleased with the recognition that our innovative SARM program has received, as well as the interest that has been generated in both the ongoing and completed clinical trials of VK5211. The designation of our Phase 2 trial design as a top 15 presentation by the FFN Global Congress underscores the enthusiasm around the potential benefits of VK5211 in the hip fracture setting," said Brian Lian, Ph.D., chief executive officer of Viking. "The VK5211 clinical results obtained to date demonstrate an encouraging overall safety and tolerability profile, as well as promising effects on muscle growth following relatively brief exposures. We expect our ongoing Phase 2 trial to provide further support for the development of VK5211 in the hip fracture and potentially other settings."

The Phase 1 trial was a single-site, in-clinic study designed to assess the safety and PK profile of VK5211 in 24 healthy subjects age 65 and older. This population was selected to be potentially representative of the general hip fracture population. Importantly, this was the first study to evaluate VK5211 in women, who comprise the majority of hip fracture patients. Subjects received once-daily oral VK5211 doses of either 1.0 mg or 3.0 mg for seven days and were assessed for safety, pharmacokinetics, and hormonal changes.

The results showed that the kinetics of VK5211 in older subjects were generally consistent with previous studies conducted in younger male subjects. The Tmax was determined to be approximately two hours post-dose, compared with one-to-three hours in healthy younger males. Mean area under the curve (AUC) values were found to be proportional to dose, and resulted in predictable accumulation upon repeat dosing. This is consistent with data from healthy younger men showing dose-proportional exposures and predictable accumulation. No significant differences in PK parameters between men and women were observed.

Treatment with VK5211 was shown to be well tolerated in this study. No serious adverse events were reported and all subjects received all planned doses of VK5211. Transient changes in lipids and hormonal patterns associated with the hypothalamic-pituitary-adrenal axis were observed. This is consistent with VK5211's known activation of the androgen receptor, as well as with previous observations in younger men. Mild elevations in mean alanine amino transferase (ALT) levels were observed in the 3.0 mg dose cohort, which returned to normal ranges following completion of the study. Dose-dependent reductions in steroid hormone binding globulin and high-density lipoprotein (HDL) were observed, as expected based on activation of the androgen receptor.

In addition to the Phase 1 poster presentation, Viking will also present a poster outlining the design of its ongoing Phase 2 study of VK5211 in patients recovering from hip fracture surgery. This poster was designated as a top 15 presentation by conference organizers and subsequently invited as an oral presentation to be delivered on September 2. The Phase 2 trial is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of VK5211 in up to 120 patients recovering from hip fracture surgery. Patients who suffered a hip fracture in the prior four-to-twelve weeks are being randomized to receive once-daily oral VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks. The study's primary endpoint is the evaluation of the effects of VK5211 on lean body mass after 12 weeks of treatment. Secondary and exploratory objectives include assessments of functional performance, quality-of-life, and activities of daily living, as well as safety, tolerability and pharmacokinetics. Viking recently announced that all planned U.S. trial sites have been opened and that the study has been expanded to Europe. The company currently expects to complete the trial in the second quarter of 2017.

The VK5211 Phase 1 poster presentation is titled, "A Phase 1 study of the selective androgen receptor modulator VK5211 in elderly males and females," and will be presented Thursday, September 1, by Steven Schoenfeld, M.D., Viking's senior vice president of clinical development.

Details regarding the upcoming oral presentation on the Phase 2 study design are as follows:

Presentation Title:

Design of a Clinical Study to Determine the Effects of the Selective Androgen Receptor Modulator VK5211 on Hip Fracture Recovery in Elderly Subjects


Friday, September 2, 2016


6:40 p.m. (local time in Rome, Italy)

Room Location:

Orange I & II

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