Rani Therapeutics Lead Program Achieves Endpoints In Repeat-Dose Part Of Osteoporosis Study

  • Rani Therapeutics Holdings Inc RANI announced topline results from Part 2 (repeat-dose portion) of the Phase 1 study of RT-102 for osteoporosis. 
  • RT-102, the RaniPill GO capsule, contains a proprietary formulation of human parathyroid hormone (1-34) analog (PTH).
  • The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering the drug with high reliability to participants via the RaniPill GO.
  • Device remnants were excreted without sequelae in all subjects.
  • In all 10 participants who completed seven days of daily, consecutive dosing, the RaniPill GO capsule demonstrated an overall drug delivery success rate of 91% over the seven days.
  • On Day 7, with more frequent, serial drug sampling after capsule swallowing on that day, the drug delivery success rate was 100%
  • RT-102 delivered 20µg of PTH with high bioavailability (relative to 20µg subcutaneous Forteo (teriparatide) in Part 1 of the study), indicating that PTH delivered via RT-102 may be efficacious at doses lower than 20μg.
  • The company anticipates initiating a Phase 2 trial of RT-102 in osteoporosis in the second half of 2023.
  • Price Action: RANI shares closed 4.64% higher at $7.90 during after-hours trading on Tuesday.
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