Rani Therapeutics has completed the first human safety study of its oral capsule designed to deliver injectable biologic therapies from within the digestive tract.
The company has already raised $142 million to bring it to this point, with its idea poised to potentially reshape markets dominated by blockbuster injectable biologics across a range of indications, which can be difficult or painful to use on a regular basis.
Upon entering the small intestine, the RaniPill capsule inflates a small balloon, which then pushes drug-loaded needles into the wall of the organ, for fast uptake into the bloodstream. The capsule uses no metal or springs, or other components that cannot be easily absorbed or passed from the body.
In the study, no sensations were reported as the capsule inflated and deployed, and participants were able to successfully pass the remnants of the device within one to four days with no adverse events, the company said. The study also showed similar times to deployment in both fed and fasted participants, showing that the presence of food does not impact performance.
According to Rani, the first-in-human safety trial follows more than 100 animal studies testing the equivalence of the capsule’s ability to deliver different injectable drugs, including antibodies, peptides and proteins. In pigs and dogs, the pill was able to deliver the equivalent of 3 mg of drug, with bioavailability matching or besting subcutaneous injections.
"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," said Rani Chairman and CEO Mir Imran.
The San Jose, California-based company plans to launch another human study this year, featuring resorbable needles filled with octreotide, a hormone therapy used to treat acromegaly as well as diarrhea associated with some tumors.