Could novel robotic oral pill replace traditional injections?

A novel oral ‘robotic pill’ demonstrated a high success rate of drug delivery, according to clinical trial data presented at the Endocrine Society’s annual meeting (ENDO 2023).

“We believe this study provides the first clinical evidence of safe and successful delivery of the osteoporosis drug teriparatide through an oral robotic pill,” stated Arvinder Dhalla, Vice President of Clinical Development at Rani Therapeutics, which was the company that developed the technology.

How does the oral robotic pill work?

When swallowed, the robotic pill is delivered to the stomach intact, due to its enteric coating. In the small intestine, the pill releases a self-inflating balloon with a microsyringe, which injects a drug-filled microneedle and delivers the medication.

“The intestines do not have pain response to needles, so the injection is painless,” Dhalla explained. The needle rapidly dissolves, allowing the medicine to be absorbed while the delivery mechanism deflates and passes safely out of the body.

Essentially, RT-102 is “a swallowable auto-injector in the form of a pill, [it] is designed to deliver the drug safely and efficiently as a painless intestinal injection,” Dhalla summarised.

“This breakthrough technology of converting injections into oral pills is a significant step” in ending painful injections patients with chronic diseases, Dhalla commented.

What drug does RT-102 contain?

In the study, RT-102 contained a dose of the drug teriparatide (PTH 1-34), which is a synthetic form of the natural human parathyroid hormone. This drug has been used to treat osteoporosis as an injectable medication (Forteo^®) for decades. Patients can take RT-102 daily for up to two years, stated the Endocrine Society.

According to Rani Therapeutics, the novel oral pill can accommodate therapeutic peptides, proteins, antibodies as well as nucleotides.

The Phase I study

Safety, tolerability and movement through the body of the oral robotic pill were evaluated in 39 healthy women, in the Phase I clinical study.

Fluoroscopic imaging was used to track the robotic pill through and out the body. Drug concentrations were measured in blood samples collected over six hours.

Study participants were divided into three groups. Two groups received either a lower or higher dose delivered with the robotic pill. The third group received a standard injection of teriparatide.

Bioavailability of RT-102 delivered by the robotic pill was comparable to or better than injected teriparatide, the study found.

The positive data from this study suggests “an oral alternative could be on the way” to treat chronic conditions like osteoporosis that require painful injections, suggested Dhalla.

Moving towards oral delivery of biologics