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Structure posts early oral obesity findings but delays larger readout after data collection mistake
2023-09-29
临床2期临床1期临床结果IPO
Structure Therapeutics aims to enter phase 2b next year.
Structure Therapeutics has shared an early look at the efficacy of its oral GLP-1 receptor agonist, linking the candidate to a 5% reduction in weight after four weeks. But a mistake in a larger, longer clinical trial has pushed back data that will give a clearer picture of how its candidate holds up against rival oral obesity drugs in development at Eli Lilly, Novo Nordisk and Pfizer.
Structure Therapeuticsructure rode rising interest in targeting GLP-1 to treGLP-1 receptor agonistGLP-1 receptorpull off a $185 million IPO earlier this year. The biotech’s lead candidate is an oral small molecule that it argues is easier to use than obesity and diabetes injectables such as Lilly’s Mounjaro and Novo’s Ozempic and has a wideobesityy window than oral candidElisLillyevNovo Nordiska cluPfizer leading drugmakers.
In the study, 24 healthy overweight or obese individuals receivGSBR-1290 three doses of GSBR-1290 or placebo. After four weeks of once-daily dosing, participants on the highest dose had a 4.9% reduction in weight compared to their counterparts on placebo. The reduction at the middle dose, 4.6%, was similar, but the difference versus placebo fell away to 1.1% at the lowest dose.
Structure’s study is small, and cross-trial comparisons are unreliable, but the result sGSBR-1290SBR-1290 is competitive. The candidate is more convenient than Pfizer’s danuglipron and Novo Nordisk’s oral semaglutide—which are given twice daily and on an empty stomach with a sip of water, respectively—and posted similar weight loss figures to Lilly’s orforglipron at four weeks.
On the safety front, the most common adverse events were classwide issues, nausea and vomiting, GSBR-1290ected more patients in the higher two dose arms than inPfizerlacdanuglipronStrucNovo Nordisk saw no semaglutide meaningful changes in liver function tests.” Pfizer dropped one of its oral obesity candidates earlier this year in response to Lillyer orforglipronl, although it is continuing to advance another asset.
One problem for Structure is that its rivals are deeper in development. Novnauseaady hvomiting 3 data on its contender, and Lilly and Pfizer have finished phase 2 studies of their assets. The presence of advanced rivals led AstraZeneca to cull its early-phase caPfizere, citing a lack of diffeobesityion, but Structure sees a space for GSBR-1290.
The biotech, which was co-founded by, and works with, Schrödinger, had pNovoed to share obesity data from a phase 2a trial tLillyould Pfizert its differentiation argument by the end of the year. However, a clinical site failAstraZenecact weight data for 24 of the 40 participants at the final, Week 12 visit, forcing Structure to enrollGSBR-1290al participants. As such, while the diabetes cohort will report out as planned, Structure delayed obesity data to the first half of next year. Structure also aims to enter phase 2b in 2024.
As Structure gathers longer-term data on GSBR-1290, it should, based on the experience oobesityivals, see patients lose more and more weight. Lilly reported a 12.4%, placebo-adjusted reduction in weight after 36 weeks, which could increase at later time points, but it expects the figure to fall short of the efficacy of injectables.diabetesobesity
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