Structure Therapeutics (GPCR) has unveiled exciting updates on its development program for GSBR-1290, a highly selective oral GLP-1 receptor agonist. In this comprehensive program update, we will delve into the key findings and milestones achieved in the Phase 2a study for diabetes and obesity, safety, tolerability, efficacy results, a Phase 1 Japanese bridging study, and toxicology studies. Additionally, we will explore the next steps in the development of GSBR-1290.
Phase 2a Study in Diabetes and Obesity:
- Randomized and Placebo-Controlled: The Phase 2a clinical trial for GSBR-1290 is a randomized, double-blind, and placebo-controlled study that has successfully enrolled 94 participants. Out of these, 60 participants were randomly assigned to receive GSBR-1290.
- Two Cohorts: The study comprises two cohorts: the T2DM cohort with 54 participants randomized to GSBR-1290 at doses of 45 mg or 90 mg, and the obesity cohort, initially enrolling 40 individuals receiving GSBR-1290 at 120 mg or a placebo. An additional 24 participants are currently being enrolled in the obesity arm, distributed 3:2 between GSBR-1290 and placebo.
- Primary and Secondary Endpoints: The primary objective of the Phase 2a study is to assess the safety and tolerability of GSBR-1290. Secondary endpoints include evaluating reductions in weight for both cohorts and HbA1c levels for the T2DM cohort.
Safety and Tolerability Results:
- Promising Safety Profile: GSBR-1290 demonstrated an encouraging safety and tolerability profile, with the majority of adverse events being mild to moderate in nature.
- No Serious Adverse Events: Importantly, there were no reported cases of serious adverse events related to the study drug, affirming its safety.
- Gastrointestinal-Related AEs: As expected for this class of medication, gastrointestinal-related adverse events were the most common, with nausea and vomiting being the top two reported side effects.
- Liver Enzyme Findings: In the obesity cohort, there were no instances of elevated liver enzymes. However, one participant in the T2DM group experienced elevated liver enzymes on day 8 while receiving 5 mg of the study drug. This participant was subsequently diagnosed with fatty liver disease.
- Study Continuation: Of the 60 participants administered GSBR-1290, only one discontinued the study due to adverse events associated with the study drug.
Efficacy Results:
- Positive Outcomes: GSBR-1290 demonstrated clinically meaningful activity in both the T2DM and obesity cohorts.
- T2DM Cohort: In the T2DM cohort, there was a statistically significant reduction in HbA1c levels at Week 12, highlighting its potential in managing blood glucose.
- Weight Reduction: Both cohorts exhibited statistically significant and clinically meaningful reductions in weight at Week 12. Importantly, weight loss continued to decrease through Week 12 in the study.
- Obesity Cohort: Interim analysis in the obesity cohort demonstrated a statistically significant and clinically meaningful decrease in weight as early as Week 8, with continued weight loss throughout the eight-week treatment period.
Results from Phase 1 Japanese Bridging Study:
- Ethnobridging Study: A Phase 1 Japanese ethnobridging study involved healthy lean Japanese participants randomized to GSBR-1290 and placebo, as well as healthy lean non-Japanese participants receiving GSBR-1290.
- Positive Findings: GSBR-1290 showcased substantial weight reduction in both Japanese and non-Japanese participants, with no discontinuations or dose reductions. Moreover, there were no serious adverse events (SAEs).
- Regulatory Implications: These promising results will be crucial for regulatory interactions in Japan, laying the groundwork for potential global studies of GSBR-1290.
Results from 6- and 9-Month Toxicology Studies:
- Safety Evaluation: In preparation for Phase 2b development with extended treatment durations, Structure conducted 6-month and 9-month toxicology studies to assess the safety of GSBR-1290.
- No Major Findings: Remarkably, no major findings or test article-related changes were observed in the liver, including ALT/AST, at all doses.
- Safety Margin: The safety margin at the therapeutic dose of 120 mg exceeded 100-fold, underscoring the drug’s safety profile.
GSBR-1290 Next Steps:
- Upcoming Milestones: The full 12-week results from the Phase 2a obesity cohort, which includes data from the additional 24 participants currently being enrolled, are anticipated in the second quarter of 2024.
- Phase 2b Obesity Study: In the second half of 2024, Structure plans to initiate a Phase 2b obesity study for GSBR-1290. This study will encompass at least 275 participants across the United States and Europe, exploring various dose titration regimens to optimize efficacy and tolerability.
- Additional Phase 2 Study: Concurrently, another Phase 2 study for T2DM is slated for the second half of 2024, aiming to further optimize the efficacy and tolerability of GSBR-1290 in this patient population.
- Formulation Bridging Study: An ongoing formulation bridging and titration optimization study, which has completed enrollment, is evaluating capsule versus tablet pharmacokinetics and different titration regimens. Results are expected in the second quarter of 2024.
- Tablet Formulation: Pending supportive data from the bridging study, the tablet formulation will be employed in future GSBR-1290 studies, commencing with the Phase 2b trials.
Bottom-line: Structure Therapeutics’ GSBR-1290 represents a promising advancement in the treatment of diabetes and obesity, with encouraging safety, tolerability, and efficacy results. The ongoing research and upcoming trials signify a bright future for this experimental GLP-1 receptor agonist, offering hope for individuals seeking effective management of these conditions.
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