Rani Therapeutics' Robotic Capsule RaniPill Successfully Completes First-in-Human Trial, Paving the Way for Oral Insulin

VCBeat (WeChat Official Account: vcbeat) has learned that Rani Therapeutics, headquartered in San Jose, California, recently announced the completion of its first-in-human trial for RaniPill, a robotic capsule designed to deliver injectable biologics from within the gastrointestinal tract, thereby replacing subcutaneous injections of biologic agents. Reportedly, the company has conducted more than 100 animal studies to date for the delivery of drugs such as insulin and Humira.

Rani Therapeutics has raised $142 million over the past seven years to support the development of its oral robotic capsule, with investors including GV (formerly Google Ventures), Novartis, AstraZeneca, and InCube Ventures. The company plans to seek additional financing in the second half of this year or early 2020, expecting to raise between $100 million and $200 million.

RaniPill features an enteric coating that protects it from stomach acid. Upon entering the intestine, the higher pH causes the coating to dissolve, triggering a chemical reaction that inflates an internal balloon. The resulting pressure within the balloon drives drug-loaded dissolvable microneedles into the intestinal wall.

Currently, Rani Therapeutics has completed the first-in-human trial of its product. The clinical trial was conducted by a contract research organization (CRO) in Texas under approval from an Institutional Review Board (IRB). Ten subjects were divided into two groups: one group ate before taking the pill, while the other did not. Each participant swallowed a drug-free RaniPill, allowing the team to focus on evaluating the device’s safety and tolerability, with X-ray tracking performed every 30 minutes.

Participants reported no sensation of pill inflation or expansion, indicating good tolerability and no adverse reactions. The company expects to conduct another human trial later this year, which will utilize drug-filled, absorbable needles.

This is similar to a recent study by the Massachusetts Institute of Technology (MIT), which developed a blueberry-sized capsule containing a micro-needle that injects insulin into the stomach after being swallowed by the patient. The needle tip inside the capsule is composed of 100% compressed, freeze-dried insulin, and the syringe is made from a biodegradable material that does not penetrate the stomach wall. The needle is attached to a tiny compressed spring, which is held in place within the capsule by a sugar disk. Upon swallowing, water in the stomach dissolves the sugar disk, releasing the spring and driving the needle into the stomach wall. Since the stomach wall lacks pain receptors, patients are unlikely to feel the injection. So far, the MIT study has achieved success in animal trials.

“This is an unprecedented innovation that integrates multiple disciplines—including engineering, chemistry, materials science, anatomy, physiology, and biochemistry—to transform injectable drug delivery into oral administration,” said Mir Imran, Chairman and CEO of Rani Therapeutics. “The safety and tolerability of the RaniPill capsule in first-in-human studies have bolstered our confidence in our technology platform as we prepare to conduct human trials of the RaniPill capsule with octreotide, a medication used to treat acromegaly, in the coming months.”

In a recent scientific article, Samir Mitragotri, a biomedical engineer at Harvard University, stated, “This field is in an exciting state. I believe it will revolutionize the way patients take their medications.” Furthermore, given that seven of the ten best-selling drugs in the United States are biologics, and most high-priced new drugs are also biologics, investor and industry interest in such technologies is likely to be very high.

(Compiled by Ning Chen)