Innovator: Mir Imran
Founder of Rani Therapeutics, based in San Jose
Form and function
Genetically engineered drugs known as biologics typically have to be injected rather than swallowed because their complex proteins break down in the stomach. Rani Therapeutics is developing a pill that will protect those proteins.
Imran, who’s founded more than a dozen companies, began working on the technology in 2010 and started Rani in 2012.
Rani has raised $70 million including funding from Google’s venture arm and drugmakers AstraZeneca and Novartis. The latter two are considering products using Rani’s technology.
Spending on biologics topped $230 billion last year, estimates researcher IMS Health. In March, Sanofi announced a partnership deal worth as much as $2.3 billion with Dice Molecules to speed its research on injection-replacing pills.
The patient swallows the pill, currently about the size of a large vitamin. The coating starts to dissolve when the pill reaches the high-alkaline level of the digestive tract, mixing its Alka-Seltzer-like components, which create carbon dioxide.
The CO2 inflates a small plastic-film balloon underneath one or two injector darts made of molded sugar, propelling them into the intestinal wall. The darts dissolve and the medicine they contain is absorbed into the bloodstream.
In animal tests using insulin and drugs for rheumatoid arthritis, daily pills appear as or slightly more effective than biweekly injections, says Imran.
Rani’s pills will need to win U.S. regulatory approval as both a drug and a medical device, delivering the proper dose of medicine and making sure the tiny balloon passes harmlessly out of the patient’s body. John Yin, professor of chemical and biological engineering at the University of Wisconsin at Madison, says the success of the complex process may also depend somewhat on the natural differences in patients’ intestinal tracts. Imran says he hopes to start human trials next year.