Source – Rani Therapeutics
In a first-in-human research, US biotech Rani Therapeutics demonstrated that its oral version of an osteoporosis medicine that is now only administered by injection performed as expected.
The ‘robotic’ tablet administers teriparatide, a kind of parathyroid hormone (PTH) that has been used to treat osteoporosis since Eli Lilly introduced it in the 1980s under the trade names Forteo/Forsteo.
A novel kind of PTH and a capsule device that is taken and passes through the stomach like any other oral pill make up Rani’s RT-102. When it enters the gut, a self-inflating balloon with tiny needles releases, allowing the drug to be injected into the intestinal wall.
The injection is painless because the intestines lack pain receptors. The balloon retracts, the needles quickly disintegrate, and the capsule may continue traveling through the intestines.
At ENDO 2023, the annual conference of the Endocrine Society in Chicago, the business presented the brand-new findings over the weekend.
39 healthy women participated in the trial and were randomly assigned to receive one of two doses of RT-102 or a regular teriparatide injection. Drug concentrations were measured over the course of the next six hours. The movement of the robotic pill through the body was also monitored using fluoroscopic imaging.
According to the findings, the medicine administered via the robotic pill had a bioavailability that was on par with or better than that of the drug administered via injection. When compared to 20 mcg of Forteo administered subcutaneously, RT-102 supplied the active medication with a 300% to 400% greater bioavailability for 20 mcg and 80 mcg of PTH, respectively.
βWe 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.β
– Arvinder Dhalla, who leads Raniβs clinical development unit