A maintenance study could shed light on the tolerability of VK2735's oral formulation in 2026, ahead of the Phase 3 trial's conclusion.
Viking Therapeutics has two Phase 3 trials in process for the subcutaneous VK2735 formulation.
Shares in Vikinig Therapeutics (NASDAQ: VKTX) rose by 16.5% in February, according to data from S&P Global Market Intelligence. The move helped the stock recover in 2026, and at the time of writing, it's only down by a low single-digit percentage this year. The increase in February followed the company's fourth-quarter earnings release and corporate update.
As ever, with smaller-market-cap biotech companies, the needle mover for their stock is pipeline developments. For Viking Therapeutics, it's its VK2735 development program. The dual GLP-1/GIP agonist (a class of drugs revolutionizing the treatment of obesity and diabetes) is in trials in both subcutaneous (under the skin) and oral forms for both indications.
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Given the advantages of oral weight-loss pills (they avoid injections, can be stored at room temperature, and are easy to take), most of the excitement centers on the oral formulation of VK2735. However, the company disappointed the market last August with its top-line results from a Phase 2 VENTURE (oral VK2735) trial in obesity. While the weight loss data (up to 12.2% mean weight loss after just 13 weeks) was impressive, the safety and tolerability (20% discontinuation rate due to adverse events in the treated group) was not. There is always a concern around gastrointestinal issues with oral formulations, and most of the issues in the Phase 2 trial came down to things like nausea, vomiting, and diarrhea.
As previously discussed, the VENTURE trial had aggressive titration, and the treated group didn't have much time to adjust to the treatment (a 13-week trial). The discontinuation rate due to an adverse event in the placebo group was 13%, suggesting the overall cohort had some challenging characteristics. Consequently, management isn't giving up on the oral VK2735 formulation, and it had good news for investors on that front.
First, the company initiated a maintenance and transition study in the fourth quarter, in which participants will initially receive VK2735 subcutaneously, then transition to a maintenance dosage in subcutaneous or oral form. Management announced that "This study is fully enrolled and we look forward to announcing the results in the third quarter of 2026."
Second, management told investors, "Following feedback from an end-of-Phase 2 meeting with the FDA, we plan to advance oral VK2735 into Phase 3 development" in the third quarter of 2026.
Third, enrollment for the Phase 3 VANQUISH-1 (subcutaneous in obesity) is complete, and Phase 3 VANQUISH-2 (subcutaneous in Type 2 diabetes) enrollment is expected to be completed in due course.
For a variety of reasons, sometimes financial, smaller biotech companies are not as good as larger ones at conducting trials. Consequently, investors need to keep an open mind over trial results, such as with the Phase 2 VENTURE trial.
The good news is that management feels confident enough to take VK2735 into Phase 3 (oral) as well as the already initiated maintenance study. Investors are hoping the latter will reveal good safety and tolerability data for the group taking an oral maintenance dose when results come out later this year.
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Lee Samaha has no position in any of the stocks mentioned. The Motley Fool recommends Viking Therapeutics. The Motley Fool has a disclosure policy.