Next Steps for the Self-Righting Insulin Pill

For type 1 diabetes patients, multiple daily injections are an unpleasant reality. But discomfort is not the only problem. “Such medication often needs to be refrigerated. Not only that, there is also a stigma associated with injections – and you create a lot of bio-waste,” says MIT’s Alex Abramson. “There is a huge preference for oral delivery of biologics.” Unfortunately, poor absorption and rapid degradation in the gastro-intestinal tract have made efficient oral delivery of insulin (and other biologics) challenging to say the least.

Calling on nature for inspiration, a multi-disciplinary group of researchers (Abramson included) based primarily at MIT designed a clever, ingestible device that aims to combine the efficacy of injection with the convenience of an oral dose (1). Once swallowed, the self-orienting millimeter scale applicator (SOMA) finds itself in the stomach, where it deploys a needle comprised of freeze-dried insulin through the gastric mucosa.

How did the researchers ensure that the device always pointed its single needle in the right direction – towards the stomach wall? Inspired by the ability of leopard tortoises to self-right, the team designed a capsule with a shape that mirrored the tortoise’s shell – a flat bottom with a steep dome. “Our design orients itself very quickly in the stomach to face the tissue wall, and then it stays in that preferred configuration,” says Abramson.

The clever shape represents just one innovation; the device also includes a sugar disc that dissolves to actuate the spring-loaded needle. Given the complexity, how likely is translation into the patient population in need? “Designing the device for mass production is something we’ve actually been considering from the beginning,” says Abramson. And, working in collaboration with the Danish pharmaceutical giant Novo Nordisk, the team is now exploring commercialization in earnest. “Novo Nordisk have brought over many manufacturing people to look at how to mass produce the device,” explains Abramson. “Every single piece in the pill can be mass manufactured using traditional techniques, such as injection moulding.”

The next phase for the project? “There are still a few more large animal studies we need to do, but we expect that human clinical trials for the pills will happen in the next 3–5 years,” says Abramson. “We’re also continuing to amplify our studies, looking at the safety and efficacy of the device. We’re particularly interested in exploring one question: what happens if you are exposed to chronic injections?”

Though diabetes has been the focus throughout, broader clinical application is also under consideration. “In our paper, we used insulin as a model drug, but our pill could potentially be used as a method to deliver other drugs as well,” says Abramson. “We’re looking into delivering drugs such as monoclonal antibodies and nucleic acids to other sites and to treat other pathologies.” It seems that the tortoise has every chance of winning the drug delivery race in the end.