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Rani Therapeutics Announces Positive Initial Phase 1a Data for RT-114 for the Treatment of Obesity, with Oral Bioavailability Exceeding Matched Subcutaneous Dosing

RANI
  • RT-114 achieved systemic exposure greater than 150% relative to a matched 12mg subcutaneous dose of PG-102 in a Phase 1a study
  • No adverse events were attributed to the RaniPill Capsule, with treatment-related side effects being mild & consistent with the GLP-1/GLP-2 agonist class
  • The Phase 1a study expanded to include an additional cohort of 15 healthy volunteers to further define the oral-to-subcutaneous pharmacokinetic relationship
  • Each volunteer in the new cohort will receive two separate 12mg doses of PG-102 via the RaniPill for a total of 24mg
  • Elimination half-life was similar between the oral RT-114 arm (5.6 days) & the subcutaneous PG-102 arm (5.3 days)
  • Data from the expanded cohort will inform dose selection for the planned Phase 1b repeat-dose study in patients with obesity
  • The Phase 1b study is expected to begin in 2026 with data anticipated in 2027
  • RT-114 is an investigational oral delivery system for PG-102, a GLP-1/GLP-2 dual agonist developed by ProGen for obesity treatment
  • Rani Therapeutics & ProGen share development costs, profits, & losses equally under their 2024 collaboration agreement