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A new self-injectable pill may soon replace subcutaneous injection treatments.

The idea for this so-called robotic pill arose out of a research project about eight years ago from InCube Labs – a life science lab run by Rani Therapeutics CEO Mir Imran, electrical and biomedical engineering graduate from Rutgers University. A leader in life science innovation, Imran has founded more than 20 medical device companies and helped develop the world’s first implantable cardiac defibrillator.

Working on the technology behind San Jose-based Rani Therapeutics, Imran and his team wanted to find a way to alleviate some of the painful side effects of subcutaneous (or subcutaneous) injections, while also improving the effectiveness of the treatment. . “The technology itself started with a very simple thesis,” Imran said in an interview. “We thought, why can’t we create a pill that has a biologic drug that you swallow, and once it gets into the gut, it transforms and delivers an injection painlessly?”

Rani Therapeutics’ approach is based on the inherent properties of the gastrointestinal tract. An injection mechanism in their pill is surrounded by a pH sensitive coating that dissolves as the capsule moves from a patient’s stomach to the small intestine. This is to ensure that the pill starts injecting the medicine in the right place at the right time. Once there, the reagents mix together and produce carbon dioxide, which in turn inflates a small balloon which helps create a pressure difference to help inject the drug-laden needles into the intestinal wall. “So it’s a cascade of really well-timed events that culminate in the delivery of this needle,” said Imran.

Despite its somewhat mechanical procedure, the pill itself contains no metals or springs, which reduces the risk of an inflammatory response in the body. Rather, needles and other components are made from injectable grade polymers, which Imran says have also been used in other medical devices. Giving the injections into the upper small intestine also carries little risk of infection, as the prevalence of stomach acid and bile from the liver prevents bacteria from easily growing there.

One of Imran’s priorities for the pill was to eliminate the painful side effects of subcutaneous injections. “It would make no sense to replace them with another painful injection,” he said. “But biology was on our side, because your intestines don’t have the kind of pain sensors that your skin does.” Additionally, administering the injection into the highly vascularized wall of the small intestine actually allows the treatment to work more effectively than when given by subcutaneous injection, which typically deposits the treatment into fatty tissue. .

Imran and his team plan to use the pill for a variety of indications, including acromegaly, diabetes, and osteoporosis, a growth hormone disorder. As of January 2020, their treatment for acromegaly, octreotide, demonstrated both safety and sustained bioavailability in primary clinical trials. They hope to pursue future clinical trials for other indications, but chose to prioritize acromegaly initially because of its well-established treatment drug, but “a very painful injection,” Imran said.

At the end of last year, Rani Therapeutics raised $ 69 million in new funding to help develop and further test their platform. “This will fund us for the next few years,” Imran said. “Our business approach is to make the technology very robust and manufacturable.”

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