Rani Therapeutics Announces Initiation of Phase 1 Study for Osteoporosis
Rani Therapeutics Holdings, Inc. recently announced the initiation of a Phase 1 study of RT-102, an oral formulation of the human parathyroid hormone analog PTH(1-34) for the treatment of osteoporosis, delivered via RaniPill capsule.
Osteoporosis is a bone loss disease that affects approximately 10 million Americans annually. While there are several medications available for the prevention or treatment of osteoporosis, PTH is one of the few anabolic (bone-building) treatments. Current forms of PTH(1-34) require daily self-injections, a treatment course characterized by poor adherence compared with oral medications. RT-102 is an optimized formulation of PTH(1-34) for oral delivery by the RaniPill capsule to the small intestine. In preclinical studies, RT-102 demonstrated a pharmacokinetic profile comparable to published data of PTH(1-34) injections for the treatment of osteoporosis.
“At Rani, our goal is to make oral biologics a reality. Today represents another step toward this goal with the progression of RT-102 into the clinic, an important milestone for Rani as we begin to evaluate PTH(1-34) delivered by the RaniPill capsule in human subjects,” said Talat Imran, Chief Executive Officer of Rani Therapeutics. “Osteoporosis is a chronic and undertreated disease that often requires frequent and painful injections. We believe that RT-102 has the potential to advance treatment of osteoporosis and reach more patients by offering a convenient, oral option.”
The first subject has been administered RT-102 in the single-center, open label, Phase 1 study, which is being conducted in Australia. The study will evaluate the pharmacokinetics (PK), safety, and tolerability of RT-102 administered in healthy adult women volunteers. RT-102 will be ingested orally, administering a single dose of parathyroid hormone. Doses will range from 20 to 80 μg.
Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics. Rani has developed the RaniPill capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection of biologics with oral dosing. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using the RaniPill capsule.
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