US-based Rani Therapeutics has reported positive data from the first-in-human study of its robotic pill designed to deliver drugs such as insulin into the small intestine wall.
The pill, dubbed the RaniPill capsule, showed 100% equivalence with injections, offering hope for replacing uncomfortable injections for diabetes patients.
RaniPill is made of an enteric coating to protect against the stomach’s acidic environment.
Upon reaching the intestine, the enteric coating dissolves and the capsule inflates a balloon, the pressure from which pushes the drug-filled, dissolvable microneedle into the intestinal wall.
The lack of sharp pain receptors in the intestine makes the injection painless.
The clinical study was conducted to evaluate the safety and tolerability of the RaniPill capsule. It tested the drug-free version of the device in a group of fed subjects as well as those who fasted.
Participants did not report any sensation of the pill inflating or deploying, and its remnants successful passed out of the body within one to four days.
The device was well-tolerated by both male and female adults, without any adverse events. Intestinal deployment times were observed to be similar in case of both fed and fasted subjects.
The company is planning to conduct further human testing of the device with a drug-filled needle.
Rani Therapeutics chairman and CEO Mir Imran said: “This is a first-of-its-kind innovation that combines a range of disciplines from engineering, chemistry and materials science to anatomy, physiology, and biochemistry to convert injectable drugs into pills.
“The safety and tolerability of the RaniPill capsule in this first human study give us confidence in our platform as we prepare for human testing of the RaniPill capsule with Octreotide (a drug for the treatment of acromegaly) in the coming months.”
The company conducted more than 100 porcine and canine studies over five years with ten molecules including antibodies, peptides and proteins.
This preclinical data revealed delivery equivalent to 3mg of drug and bioavailability similar to or better than subcutaneous injections.