Viking Therapeutics pushes GLP-1/GIP obesity pill to phase 3

Viking Therapeutics plans to advance the oral version of its leading drug candidate into phase 3 development later this year, following positive results from its mid-stage study, the company announced yesterday.

The investigational GLP-1/GIP receptor dual agonist, dubbed VK2736, is being developed in oral and injectable formulations as Viking builds out its late-stage obesity program.

VK2736's oral program is slated to begin phase 3 testing for obesity in the third quarter of the year, Brian Lian, Viking's President and CEO, said during yesterday's earnings call.

The company recently wrapped up its end-of-phase 2 talks with the FDA and received feedback, Lian also said.

"We'll provide more details on study design in the coming months," Lian added.

Viking's decision to push its obesity hopeful into late-stage development is buoyed by encouraging top-line results from the phase 2 Venture oral study, which were announced last year. The trial met its primary and secondary endpoints, with patients achieving a mean weight loss of 12.2% at 13 weeks without plateauing, setting the stage for even greater weight loss results in phase 3 development.

The California-based drugmaker is also planning to advance the subcutaneous version of its main asset through its phase 3 Vanquish program, which includes two studies -- Vanquish-1 for obesity and Vanquish-2 for obesity and type 2 diabetes.

Enrollment in Vanquish-1 finished ahead of schedule at the end of last year, while Vanquish-2 is expected to complete enrolling patients later this quarter, the company shared.

Currently, Viking Therapeutics has no approved products and has yet to generate revenue, placing the advancement of VK2736 at the heart of the company's growth strategy.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.