Novel robotic pill can safely deliver injectable osteoporosis drug
An oral robotic pill could soon provide an alternative to painful injections in treating osteoporosis and other chronic diseases.
Teriparatide (PTH 1-34) has for decades been a proven and effective medication for rebuilding brittle bones characteristic of osteoporosis. But the drug, which was launched by Eli Lilly under the brand name Forteo, has to be taken by daily injection for up to two years.
However, a study presented at ENDO 2023 – the Endocrine Society’s annual meeting in Chicago in the US – suggests the medication could be safely and easily administered by a novel robotic pill.
Arvinder Dhalla, who leads clinical development at Rani Therapeutics, the San Jose, California-based company that has developed the technology and funded the study, said: “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.”
When a person swallows the robotic pill, it moves through the stomach intact. In the intestine the pill releases a self-inflating balloon with a microsyringe, which injects a drug-filled microneedle and delivers the medication.
Dr Dhalla explained: “The intestines do not have pain response to needles, so the injection is painless.”
Rani’s robotic pill can navigate through the stomach and enter the small intestine where the capsule injects the drug into the intestinal wall. Image: Rani Therapeutics
The needle rapidly dissolves, and the medication is absorbed while the delivery mechanism deflates and is safely passed out of the body.
Dr Dhalla added: “The robotic pill, which is essentially a swallowable auto-injector in the form of a pill, is designed to deliver the drug safely and efficiently as a painless intestinal injection.
The Phase I study of 39 healthy women evaluated the safety, tolerability and movement through the body of the robotic pill, known as RT-102, containing a dose of teriparatide, which is a synthetic form of the natural human parathyroid hormone.
Study participants were divided into three groups. Two groups received either a lower or higher dose delivered with the robotic pill, and the third group were given a standard injection of teriparatide.
Fluoroscopic imaging was used to track the robotic pill through and out of the body. Drug concentrations were measured in blood samples collected over six hours.
The study found the bioavailability (the ability of the medication to be absorbed and used by the body) of the drug delivered by the robotic pill was comparable to or better than teriparatide given via the injection.
“This breakthrough technology of converting injections into oral pills is a significant step forward towards ending the burden of painful injections for millions of patients suffering from chronic diseases,” Dr Dhalla said.
Rani Therapeutics has indicated it hopes to begin a Phase 2 trial of RT-102 in patients with osteoporosis later this year.
The clinical-stage biotech company is also working on a new higher capacity version of the robotic pill which could be used to deliver larger molecules, such as monoclonal antibodies, which are laboratory-produced particles that act like human antibodies in the immune system.
