New auto-injection capsules may soon replace subcutaneous injection therapy.
The idea for this so-called robot capsule (robot pill) came from a research project at InCube Labs, a life science lab. The lab is run by Mir Imran, chairman and CEO of Rani Therapeutics, who earned a bachelor’s degree in electrical and biomedical engineering from Rutgers University about eight years ago. Famous for his innovations in life sciences, Imran has set up more than 20 medical device companies to help develop the world’s first implantable cardioverter-defibrillator.
When San Jose-based Rani Therapeutics is working on its underlying technology, Imran and his team will reduce the painful side effects of subcutaneous (or under-skin) injections while reducing the effectiveness of the treatment. I wanted to find a way to improve. “The technology itself started with a very simple hypothesis,” Imran said in an interview. “I wondered why I couldn’t make a capsule containing a biological drug that the patient swallowed. When it reaches the intestine, the capsule itself deforms and the injection is painless.”
Rani Therapeutics’ approach is based on the unique properties of the gastrointestinal tract. The capsule injection mechanism is covered with a pH-sensitive coating that dissolves as it travels from the patient’s stomach to the small intestine. This ensures that the capsule injects the drug in the right place at the right time. Upon reaching the destination, the reactants mix to produce carbon dioxide. Carbon dioxide inflates a small balloon, creating a pressure difference that puts a drug-filled needle into the intestinal wall. “That is, the needle reaches its destination when a series of events happen in a really timely manner,” Imran said.
Despite the mechanical procedure, the capsule itself does not contain metal or springs, reducing the likelihood of an inflammatory reaction in the body. Instead, needles and other components are made of injectable grade polymers and are also used in other medical devices, according to Imran. When injected into the upper part of the small intestine, there is little risk of infection because stomach acid and the spread of bile from the liver impede bacterial growth.
One of Imran’s priorities for capsules was to eliminate the painful side effects of subcutaneous injections. “It doesn’t make sense to replace it with another painful injection,” he said. “But biology has sided with us. There are no pain sensors in the intestines like those on the skin.” In addition, injections into the highly angiogenic wall of the small intestine work more efficiently than subcutaneous injections, which usually put the drug in adipose tissue.
Imran and his team plan to use capsules for a variety of indications, including growth hormone disorder acromegaly, diabetes, and osteoporosis. Octreotide, a treatment for acromegaly, demonstrated both safety and sustained bioavailability in a primary clinical trial in January 2020. They hope to continue clinical trials for other indications in the future, but initially chose to prioritize acromegaly. Established treatments for acromegaly require “extremely painful injections,” Imran said.
At the end of 2020, Rani Therapeutics raised $ 69 million in new funding to further develop and test the platform. “This will fund us in the next few years,” said Imran. “Our approach to business is to make technology extremely robust and manufacturable.”