Case Studies
Endocrinology Programs
GLP-1/GIP Dual Agonist
Challenge
Managing GI tolerability concerns and thyroid safety signals while demonstrating superior weight loss and glycemic control
ArcaScience Approach
Integrated Phase 2/3 data across diabetes and obesity trials with dose-titration-stratified safety analysis and thyroid monitoring
Results
- ✓GI tolerability profile characterized by dose titration speed
- ✓Thyroid C-cell monitoring framework established
- ✓Dual-indication BRA package prepared in 5 weeks
SGLT2 Inhibitor
Challenge
Expanding BRA beyond diabetes to cardiovascular and renal indications while managing DKA and genital infection risks
ArcaScience Approach
Cross-indication BRA integrating 4 CVOTs and 2 renal outcome trials with indication-specific benefit and risk quantification
Results
- ✓Cross-indication safety profile unified
- ✓DKA risk contextualized by indication
- ✓Supported 3 supplemental NDA submissions
Once-Weekly Basal Insulin
Challenge
Demonstrating non-inferior hypoglycemia profile versus daily basal insulins with improved adherence-adjusted outcomes
ArcaScience Approach
Hypoglycemia-focused BRA with time-in-range analysis from CGM data and adherence-adjusted benefit modeling
Results
- ✓Hypoglycemia rate comparison automated
- ✓CGM-derived time-in-range benefit quantified
- ✓64% reduction in BRA preparation time
Aggregate Outcomes
Results Across Endocrinology Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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