Viking Reports Promising Phase I Results for Obesity Pill

In a significant development in the field of obesity treatment, Viking Therapeutics recently released impressive preliminary data from the first human study of its investigational oral drug, VK2735. The results, unveiled at The Obesity Society’s ObesityWeek 2024 meeting in San Antonio, Texas, highlight substantial weight loss and a promising safety profile in healthy adults.

Patients who received a 40-milligram dose of VK2735 once daily for 28 days experienced an average weight reduction of up to 5.3% from their initial weight, a result that was statistically significant in comparison to a placebo. More notably, a 100-milligram dose of VK2735 led to an average weight loss of 8.2% over the same period. This higher dose was similarly effective, showing a statistically significant 6.8% reduction in body weight relative to placebo, with a p-value of less than 0.001.

Jefferies analyst Roger Song commented that the outcomes exceeded expectations, noting that VK2735 showed "class-leading" weight loss among oral obesity treatments. He emphasized that the drug had likely surpassed the best-case scenarios, displaying the highest weight loss among all oral medications under development, while maintaining a favorable safety profile.

Evan Seigerman, an analyst at BMO Capital Markets, noted the absence of a weight loss plateau in the 100-milligram dose group after 28 days of treatment. He also observed that the weight loss effects of VK2735 persisted for an additional four weeks even after discontinuing the medication.

In terms of safety, the early-stage study reported that all treatment-emergent adverse events were mild to moderate, with most being mild. Gastrointestinal side effects were largely manageable, with nearly 80% of these side effects being mild as well. There was no significant difference in gastrointestinal adverse events between the VK2735 and placebo groups.

This early data positions Viking ahead of Structure Therapeutics, which had reported a 6.2% placebo-adjusted weight loss with its investigational obesity drug GSBR-1290 in a Phase IIa study in June 2023. Earlier in October 2023, GSBR-1290 showed a placebo-adjusted weight reduction of 4.9% in Phase I data. Although direct comparisons between the two studies are challenging due to differences in design and sample populations, analysts expect investors to compare the weight loss outcomes directly.

Additionally, Viking presented Phase IIa data for its subcutaneous formulation of VK2735 at ObesityWeek 2024. This version, administered as a weekly injection, resulted in up to 14.7% weight loss from baseline after 13 weeks. The weight reduction was progressive and did not plateau during the study. Pharmacokinetic data suggested that the subcutaneous form has a half-life of 171 days, indicating the potential for once-a-month maintenance dosing. This could set VK2735 apart from current market leaders like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, which require weekly dosing.

Despite the growing interest in oral obesity medications, Truist Securities analyst Joon Lee believes that subcutaneous (injectable) treatments will maintain their dominance in the obesity market. Oral drugs are expected to serve as adjunctive therapies, particularly appealing to younger patient demographics. Lee's outlook is supported by a survey indicating that injectable therapies remain more prevalent, with notable interest in oral treatments primarily among younger patients.

In summary, Viking Therapeutics' VK2735 has shown promising early results as an oral obesity treatment, potentially setting a new benchmark in the field. With a solid safety profile and significant weight loss outcomes, VK2735 could emerge as a competitive option in the obesity treatment landscape.