Structure Therapeutics has offered an initial glimpse into the effectiveness of its oral GLP-1 receptor agonist, reporting a notable 5% reduction in weight among participants after just four weeks of use. This development generated significant interest, with Structure successfully completing a $185 million IPO earlier this year. The company’s leading candidate is an oral small molecule, GSBR-1290, which it contends is more user-friendly compared to injectable treatments for obesity and diabetes, such as Lilly’s Mounjaro and Novo’s Ozempic. It also boasts a wider safety margin compared to oral candidates being developed by other pharmaceutical leaders.
Structure has initiated the release of clinical data on GSBR-1290, starting with single ascending dose results in June, and more recently, sharing findings from a phase 1b multiple ascending dose trial. In this study, 24 individuals who were either overweight or obese received varying doses of GSBR-1290 or a placebo. After four weeks of daily dosing, participants in the highest-dose group experienced a remarkable 4.9% reduction in weight compared to the placebo group. The middle-dose group showed a similar 4.6% reduction, while the lowest-dose group exhibited a more modest 1.1% difference from the placebo.
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While it’s important to note that Structure’s study is relatively small and making direct comparisons between trials is challenging, these results suggest that GSBR-1290 holds its own in terms of competitiveness. Notably, it offers greater convenience than Pfizer’s danuglipron and Novo Nordisk’s oral semaglutide, both of which require twice-daily dosing and specific administration conditions. Moreover, GSBR-1290 demonstrated weight loss figures comparable to Lilly’s orforglipron at the four-week mark.
In terms of safety, the most common side effects observed were consistent with the class of drugs, namely nausea and vomiting, with a higher incidence in the two higher-dose groups compared to the placebo group. Notably, Structure reported no significant changes in liver function tests, a concern that prompted Pfizer to halt one of its oral obesity candidates earlier this year.
However, Structure faces a challenge in that its competitors are further along in their development stages. Novo has already presented phase 3 data on its contender, while Lilly and Pfizer have completed phase 2 studies for their respective candidates. AstraZeneca even withdrew its early-phase candidate due to a perceived lack of differentiation. Despite this, Structure remains optimistic about the potential for GSBR-1290.
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The biotech had initially planned to unveil obesity data from a phase 2a trial by the end of this year to bolster its case for differentiation. However, a clinical site’s failure to collect weight data for a portion of the participants during the final Week 12 visit necessitated the enrollment of additional participants. Consequently, the release of obesity data has been postponed to the first half of the coming year. Structure is also gearing up to enter phase 2b in 2024. As the company accumulates more extended-term data on GSBR-1290, it anticipates witnessing progressive weight loss in patients, a trend seen in the experiences of its rivals. Lilly, for instance, reported a remarkable 12.4% reduction in weight after 36 weeks, albeit placebo-adjusted, with potential for further improvement over time.
While the projected disparity in efficacy raises questions about the preference for injectable treatments, Lilly sees potential for oral options, particularly in “middle-income markets in China,” where pricing is a pivotal factor.
