Viking Therapeutics Stock Climbs On Positive Data From VK2735 Obesity Program

Viking Therapeutics

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(RTTNews) - Shares of Viking Therapeutics, Inc. (VKTX) were gaining around 17 percent in the pre-market activity on the Nasdaq after the company reported positive new clinical data from its VK2735 obesity program. The company noted that higher doses of its oral tablet formulation increased patients' weight loss beyond earlier formulations.

Viking further said it plans to discuss with the U.S. Food and Drug Administration the clinical path forward for injectable VK2735 later this quarter, and expects to initiate a Phase 2 study of the oral tablet formulation of VK2735 by the end of this year.

VK2735 is a dual agonist of the glucagon-like peptide 1 or GLP-1 and glucose-dependent insulinotropic polypeptide or GIP receptors being developed for the potential treatment of various metabolic disorders. Viking is evaluating both subcutaneous and oral formulations of VK2735 in clinical trials.

In a presentation at ObesityWeek 2024, the annual meeting of the Obesity Society, the company presented updated data from the previously reported Phase 1 multiple ascending dose or MAD clinical trial of an oral tablet formulation of VK2735 dosed daily for 28 days, including results for the study's 60 mg, 80 mg, and 100 mg daily treatment cohorts.

These results continued to show positive signs of clinical activity over the 28-day treatment period in the study. Cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2 percent. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6.8 percent.

The company added that persistent weight loss effects were observed at follow-up visits through Day 57, ranging up to 8.3 percent from baseline, four weeks after the last dose of VK2735 was administered.

Based on a preliminary evaluation of weight loss trajectories at multiple dose levels, continued treatment beyond 28 days is expected to provide further reductions in body weight.

Earlier in March, Viking had reported positive results from the Phase 1 study of VK2735, in which participants showed reductions in mean body weight compared with placebo, ranging up to 3.3 percent, after 28 days. Those took a 40-mg oral dose lost 5.3 percent of body weight during the same time frame.

A second poster presentation highlighted follow-up results from the company's Phase 2 VENTURE clinical trial of VK2735 demonstrating the treatment's longer-term maintenance effects and pharmacokinetic information.

As previously reported, patients receiving weekly doses of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 14.7 percent from baseline.

The presentation also included newly reported data from a subset of patients assessed for pharmacokinetic or PK measures.

Brian Lian, chief executive officer of Viking, said, "We believe the VENTURE data demonstrate VK2735's promising efficacy and tolerability profile through 13 weeks of weekly dosing and support our belief that less frequent dosing regimens may provide effective maintenance of weight control. The updated oral Phase 1 study results continue to demonstrate an encouraging tolerability profile and promising signs of clinical activity at doses of up to 100 mg daily. We believe the durable effects observed following 28 days of dosing suggest potential opportunities to introduce lower dose regimens following an initial induction of weight loss."

In pre-market activity on the Nasdaq, Viking shares were trading at $85.15, up 16.84 percent.

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