Rani Therapeutics’ oral ‘robotic pill’ delivers injection trans-enterically
US Rani Therapeutics, a clinical-stage biotherapeutics company, has reported new results from its phase 1 trial into the RaniPill capsule at The Endocrine Society’s ENDO 2023 conference.
The RaniPill (RT-102) is an orally administered robotic pill (RP) that delivers teriparatide, a form of parathyroid hormone (PTH), through the gastrointestinal tract to the peritoneal space, where a self-inflating balloon covered in microneedles is released, injecting the drug trans-enterically. The needles then dissolve and the balloon is retracted, allowing the RP to continue through the tract. As the intestines have no pain receptors, the injection is painless.
The phase 1 study involved 39 healthy women randomised to receive either one or two doses of RT-102 or a standard injection with teriparatide. Drug concentrations were collected over the following six hours, and fluoroscopic imaging was used to track the passage of the RP through the body. Results showed that the bioavailability of teriparatide via RT-102 was comparable to, or better than, the drug administered via injection.
Teriparatide has been used to treat osteoporosis for decades. The company has stated that it intends to start a phase 2 trial of RT-102 in patients with osteoporosis in the second half of 2023. It also announced that it is devising a higher-capacity version of the RP which could be used to deliver large molecules such as monoclonal antibodies.
Arvinder Dhalla, who leads Rani’s clinical development unit, commented: “We believe this study provides the first clinical evidence of safe and successful delivery of the osteoporosis drug teriparatide through an oral robotic pill. Data from this study are very encouraging and should give hope to those suffering from chronic conditions that require painful injections, like osteoporosis, that an oral alternative could be on the way.”
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