Rani Therapeutics provides update following pre-IND meeting with FDA

Rani Therapeutics announced that it completed a pre-Investigational New Drug, IND, meeting with FDA with respect to RT-102, the RaniPill GO containing a proprietary formulation of human parathyroid hormone analog for the potential treatment of osteoporosis, and provided a corporate update. Following feedback from a pre-IND meeting with the FDA, Rani believes that a 505(b)(2) pathway is suitable for the development of RT-102 in the U.S. In addition, Rani obtained guidance from the FDA on its preclinical and clinical development plans for RT-102, including the Phase 2 clinical trial which is expected to initiate in the second half of 2023. In December 2022, Rani announced positive topline results from Part 2 (repeat-dose portion) of the Phase 1 study of RT-102. RT-102 is being developed for the treatment of osteoporosis. The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering drug with high reliability to participants via the RaniPill GO.