Viking Therapeutics Stock Plunges as Phase 2 Trial Reveals Mixed Results with VK2735

Viking Therapeutics, Inc., a clinical-stage biopharmaceutical entity, has announced promising top-line results from its Phase 2 VENTURE-Oral Dosing trial of VK2735 in obese patients. The study demonstrated statistically significant reductions in body weight following once-daily doses of the oral tablet formulation of VK2735. Participants experienced a progressive mean weight loss of up to 12.2% over a 13-week period compared to 1.3% observed in placebo cohorts.

The trial successfully achieved its primary endpoint by showcasing significant weight reduction relative to placebo. Subjects on doses above 15 mg consistently demonstrated weight loss starting from the first week, with no plateau observed by week 13. A noteworthy 97% of those treated with VK2735 achieved a reduction of ≥5% in body weight, in stark contrast to 10% in the placebo group. Similarly, 80% of participants achieved ≥10% weight loss compared to 5% on the placebo.

Safety and tolerability were encouraginly noted across various doses of VK2735. Despite gastrointestinal adverse events remaining prevalent reasons for discontinuation, the drug's overall discontinuation rates were balanced when compared to subjects on placebo, with 20% of VK2735 recipients and 13% of placebo recipients discontinuing treatment due to adverse events. The majority of gastrointestinal-related treatment emergent adverse events (TEAEs) were classified as mild or moderate.

Additionally, a study arm focused on weight loss maintenance through exploratory low-dose treatment showed promising initial results. In this cohort, rapid titration to 90 mg followed by a down-titration to 30 mg daily led to maintained body weight reduction beyond the high-dose phase. Results implied potential for effective weight maintenance at doses lower than 30 mg.

Viking Therapeutics expressed anticipation about continuous exploration in upcoming trials, citing potential for improved outcomes with extended dosing durations. The company's commitment to innovation was affirmed by plans to initiate further studies that explore maintenance dosing strategies.

The Phase 2 VENTURE trial was characterized by its randomization and double-blind setup involving 280 adults, classified as obese or overweight with related comorbidities. It was strategically structured to assess VK2735's safety, tolerability, pharmacokinetics, and weight loss efficacy through a 13-week daily oral tablet regimen.

Investors' reactions to the mixed trial results, which highlighted substantial trial discontinuation rates due to gastrointestinal side effects, resulted in a steep drop in Viking Therapeutics’ stock. Nonetheless, these trial results underscore Viking Therapeutics’ positioning as a competitor in the growing weight-loss market, given the advantages posed by oral alternatives in therapeutic delivery. The company remains hopeful for future study phases and advancements in both oral and injectable formulations of VK2735 and other metabolic therapies under development.