Rani Therapeutics Holdings, Inc. has completed a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) with respect to RT-102, the RaniPill GO containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis, and provided a corporate update.
Following feedback from the meeting with the FDA, Rani Therapeutics 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 Therapeutics 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 the drug with high reliability to participants via the RaniPill GO.
Transformative milestones for Rani Therapeutics
“We thank FDA for its feedback and helping us chart the path forward for RT-102. As we enter 2023, Rani has multiple upcoming clinical milestones that we believe could be transformative for the company, including the initiation of a phase 2 trial for RT-102 – our first phase 2 trial – and the initiation of three additional phase 1 studies, including two antibody programs,” said Talat Imran, CEO of Rani Therapeutics.
“We are delighted by the recent results from our RT-102 program, with positive Phase 1 single and repeat-dose data reinforcing the potential of the RaniPill platform as an oral delivery solution for biologics. We plan to carry this momentum forward, and I look forward to providing further updates in coming months.”
Rani Therapeutics said the RT-102 phase 2 initiation will take place in the second half of 2023, while three additional phase 1 studies will start in 2023 with RT-105 containing an adalimumab biosimilar; RT-110 containing PTH for hypo-parathyroidism; and RT-111 containing an ustekinumab biosimilar for psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis.