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.