The search for a way to orally administer biologics has led Novo Nordisk to the leopard tortoise. By mimicking the shape of the tortoise’s shell, researchers at MIT and Novo have come up with an oral capsule capable of injecting biologics including Humira into the lining of the stomach.
Writing in Nature Biotechnology, the researchers describe the use of the capsule to deliver doses of up to 4 mg to pigs. The capsule supports the administration of drugs in fast-acting liquid forms. Peak plasma drug concentration was reached within 30 minutes after dosing. Quick, consistent dosing was also enabled by the targeting of the stomach rather than organs further down the digestive tract.
Novo contributed to the funding of the work, and its researchers were listed among the authors of the paper. Having shown the potential of the technology in pigs, Novo is now working to advance the delivery system into human tests.
“Although it is still early days, we believe this device has the potential to transform treatment regimens across a range of therapeutic areas. Our aim is to get the device into clinical trials as soon as possible,” Ulrik Rahbek, vice president at Novo Nordisk, told MIT News.
The capsule is roughly egg-shaped. MIT hit upon the design as a way to ensure the capsule keeps its needle facing toward the lining of the stomach. Just as the steep shell of the leopard tortoise allows the creature to roll over if it ends up on its back, the capsule is designed to orient itself so the needle is lined up for administration of the biologic.
When the capsule is swallowed, the needle and plunger are held back by a sugar pellet. The pellet dissolves in the stomach, causing the needle to enter the stomach lining and the plunger to push the liquid drug out of the capsule. The researchers tested the capsule using Humira, a GLP-1 analog, recombinant human insulin and epinephrine.