Viking Touts Promising Phase I Weight Loss Data for Obesity Pill Candidate

 

Jefferies analyst Roger Song in an investor note said that Viking Therapeutics’ readout for its investigational therapy VK2735 exceeded expectations, with “class-leading” weight loss. Patients on 100-miligram doses of the pill lost 8.2% of their body weight after 28 days.

Viking Therapeutics on Sunday unveiled early data from the first-in-human study of its investigational oral obesity drug VK2735, touting strong weight loss in healthy adults and an encouraging safety profile.

After 28 days of once-daily dosing, 40-mg VK2735 lowered body weight by up to 5.3% from baseline, an effect that was statistically significant versus placebo. Weight loss was more pronounced among patients who were treated with 100 mg of VK2735—the highest dose level—which elicited an average weight reduction of 8.2%.

Relative to placebo, the 100-mg VK2735 dose cut 6.8% of participants’ body weight, a statistically significant effect with a p-value less than 0.001, according to Viking’s presentation at The Obesity Society’s ObesityWeek 2024 meeting in San Antonio, Texas.

In an investor note, Jefferies analyst Roger Song said that Viking’s readout “exceeds expectations” with VK2735 achieving “class-leading weight loss.” The oral obesity pill “has likely exceeded the best scenario, showing highest [weight loss] among all oral pipeline,” all while maintaining a clean safety profile, Song wrote.

BMO Capital Markets analyst Evan Seigerman in an investor note pointed out that there seemed to be no weight loss plateau in the 100-mg dose group through 28 days of treatment, and that VK2735’s effects were maintained for another four weeks after stopping treatment.

In the early-stage study, Viking reported that all treatment-emergent adverse events were either mild or moderate in severity, with the majority being mild. Gastrointestinal side effects were likewise broadly manageable, with nearly 80% being mild in severity. There was no clinically meaningful difference in gastrointestinal toxicities between participants in the VK2735 and placebo arms.

Despite being early and from a relatively small study, Sunday’s results put Viking slightly ahead of Structure Therapeutics, which in June 2023 reported that its investigational obesity pill GSBR-1290 resulted in a placebo-adjusted 6.2% weight loss in a Phase IIa study. Phase I data in October 2023 demonstrated 4.9% placebo-adjusted weight reduction.

While there have yet to be head-to-head comparisons, and despite the difficulties of comparing two studies with different designs and different samples, “expect investors to directly compare ‘1290’s Ph 1 4.9% placebo-adjusted data to VK2735’s 6.8%,” Seigerman said.

Also at ObesityWeek 2024, Viking unveiled Phase IIa data for its subcutaneous formulation of VK2735, demonstrating that a weekly shot of the obesity candidate resulted in up to 14.7% weight loss from baseline after 13 weeks. The effect of the subcutaneous drug was “progressive” throughout the study and showed no plateau, according to Viking’s abstract.

However, pharmacokinetic data from the mid-stage trial showed that the subcutaneous formulation had a half-life of 171 days, which according to Truist Securities analyst Joon Lee is “supportive of once-a-month maintenance dosing.” This could help differentiate VK2735 from Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound—the current market leaders in the weight loss space—which are dosed weekly.

Despite the mounting interest in—and investment in—oral obesity drugs, “we think [subcutaneous] will continue to dominate obesity [market] with orals coming in as adjunctive therapy,” Joon wrote, referencing the firm’s survey which showed that more patients are on injectable therapies and most of the interest in oral treatments observed in younger patients.

https://www.biospace.com/drug-development/viking-touts-promising-phase-i-weight-loss-data-for-obesity-pill-candidate