Rani study for osteoporosis treatment RaniPill GO achieves all endpoints

Rani Therapeutics Holdings announced topline results from Part 2 of the Phase 1 study of RT-102, the RaniPill GO capsule containing a proprietary formulation of human parathyroid hormone analog PTH 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. "The data are highly encouraging and reinforce the tolerability and high bioavailability of RT-102 that was observed in Part 1 of the study," said Mir Hashim, PhD, Chief Scientific Officer of Rani. "The RaniPill GO capsule continues to deliver drug payloads to subjects at success rates exceeding 90%. Importantly, we believe the safety, reliability, and pharmacokinetic data that we collected through both parts of the Phase 1 study support the initiation of a Phase 2 trial of RT-102 in osteoporosis, which we anticipate beginning in the second half of 2023." "The repeat-dose data contribute to our growing body of preclinical and clinical data that we believe support the viability of the RaniPill(TM) platform to orally deliver biologics and drugs to treat chronic diseases," said Talat Imran, Chief Executive Officer of Rani. "These data give us confidence to move forward with multiple programs in parallel, including our ustekinumab biosimilar and adalimumab biosimilar programs, and to expand manufacturing scale-up. We can see a future where millions of patients no longer carry the burden of regular injections."