Rani Therapeutics RANI announced positive topline results from the single-ascending dose (SAD) portion of its Phase 1 clinical study of its lead asset RT-102 for the potential treatment of osteoporosis.
RT-102 is a RaniPill capsule containing a proprietary formulation of human parathyroid hormone (PTH) analog PTH (1-34) for the treatment of osteoporosis.
The clinical trial achieved all of its endpoints, with RT-102 being generally well-tolerated and demonstrating high oral bioavailability of Rani’s PTH analog.
RT-102 was generally well-tolerated, with no RaniPill-related adverse events (AEs) observed in study participants. The RaniPill platform has now been tested in more than 80 healthy volunteers.
Talat Imran, Chief Executive Officer, commented: “Importantly, this marks the first results of our second Phase 1 clinical trial, following on the positive results we previously announced for RT-101, the RaniPill capsule containing octreotide. Our RaniPill platform has now been tested in more than 80 healthy volunteers, and the incremental enhancements we have made to the RaniPill design have further increased drug delivery success rate.”
The company is planning to share these positive results with the U.S. Food and Drug Administration and intends to initiate a Phase 2 trial for RT-102 in the United States during the third quarter of 2023, subject to IND approval.
Price Action : Rani Therapeutics shares trading around 8 percent higher at $12 on Wednesday during after-hours session.
Image and article originally from www.benzinga.com. Read the original article here.