Rani Therapeutics, a clinical stage biotherapeutics company focused on the oral delivery of biologics, has initiated a Phase I study of RT-102, an oral formulation of the human parathyroid hormone analog PTH(1-34) for the treatment of osteoporosis, delivered via capsule.
The first subject has been administered RT-102 in the single-centre open label, Phase I 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.
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 characterised by poor adherence compared with oral medications. RT-102 is an optimised 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.
Talat Imran, Chief Executive Officer of Rani Therapeutics, said: “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.”