Key Takeaways:
Viking Therapeutics Inc. (NASDAQ: VKTX) reported its oral obesity drug VK2735 produced a mean weight loss of up to 12.2% after 13 weeks in a Phase 2 study, positioning the company to advance into late-stage trials.
"The Phase 2a VENTURE-Oral Dosing study results provide important data to inform the design of our upcoming oral Phase 3 registration studies," Brian Lian, Ph.D., chief executive officer of Viking Therapeutics, said in a statement. "We are excited to move oral VK2735 into Phase 3 development as we believe it has the potential to become the first oral dual agonist of the GLP-1 and GIP receptors to reach the market."
The data, presented at the European Congress on Obesity, showed dose-dependent weight loss across all cohorts. Patients on the highest 120 mg dose saw a 12.2% mean reduction in body weight, equivalent to 26.6 pounds, compared to a 1.3% reduction for placebo (p<0.0001). Eighty percent of participants in that cohort achieved at least 10% weight loss, versus just 5% for placebo. The drug was well-tolerated, with most adverse events being mild to moderate gastrointestinal issues.
The positive results strengthen VK2735's potential as a competitive oral treatment in the lucrative market for GLP-1 drugs, currently dominated by injectables from Novo Nordisk and Eli Lilly. Viking plans to initiate Phase 3 trials for the oral formulation later this year. The company is also developing a subcutaneous version of VK2735, which is currently in its own Phase 3 program.
The VENTURE-Oral trial was a 13-week, randomized, double-blind, placebo-controlled study that enrolled 280 adults with obesity or those who were overweight with at least one weight-related condition. The study population had an average body mass index (BMI) of 37 and an average age of 51 years.
"From a clinical perspective, the early onset and continued progression of weight loss without plateau over 13 weeks is particularly compelling," said Parke Joseph Hedges, a lead investigator in the study. Weight loss began as early as the first week and continued throughout the treatment period.
VK2735 is a dual agonist, targeting both the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, similar to Eli Lilly's Zepbound. The availability of an effective oral option could be a significant advantage for patients and physicians.
The positive data provides a crucial catalyst for Viking Therapeutics, which has seen its stock decline nearly 10% year-to-date. The company's next major milestone will be the initiation of the Phase 3 program for oral VK2735, expected later this year. Successful development and commercialization would place Viking in a strong competitive position within the rapidly growing obesity drug market.
This article is for informational purposes only and does not constitute investment advice.
