The luminal unfolding microneedle injector (LUMI) capsule in development at MIT in collaboration with scientists from Novo Nordisk, aims to orally deliver drugs that would normally need to be injected. If the capsule is proven safe and effective in clinical trials, it could greatly help expand the range of treatment options available to patients receiving biologic therapies, says GlobalData, a leading data and analytics company.

When treating chronic diseases, it is crucial that the therapies not only be effective, but also easily tolerated and administered by patients. Although biologic therapies like insulin and TNF-α inhibitors have transformed the standard of care in their respective indications, nearly all biologics require administration via subcutaneous or intravenous injection. These methods of administration are often inconvenient and uncomfortable for patients.

Rose Joachim, Senior Immunology Analyst at GlobalData, comments: “Oral delivery of biologics has been long complicated by the poor absorption of the larger macromolecules through the intestinal wall. The LUMI capsule aims to address this problem through the use of microneedles that deploy upon reaching the small intestine, carefully penetrating the walls and delivering a drug directly into the bloodstream. As it is being developed in collaboration between scientists from MIT and Novo Nordisk, it is possible the technology will soon be seen in Novo Nordisk’s pipeline or perhaps as the flagship product of a spin-out or start-up venture.”

There certainly appears to be an unmet need in the market. For example, excluding vaccines and allergenics, GlobalData estimates that across the entire US pharmaceutical market there are only six marketed and 14 Phase III or later orally administered biologic or synthetic peptide therapies. This is despite there currently being hundreds of biologic therapies available on the US market and in late stage clinical development.

Joachim adds: “Interestingly, a similar therapy is in development by a small biotech company called Rani Therapeutics. The RaniPill is a capsule containing machinery that can also inject a drug of interest directly into the intestinal wall. In late 2017, Rani and Shire entered into a collaboration to evaluate the use of the RaniPill in the oral delivery of Factor VII.

“This vote of confidence from big pharma, along with the announcement of a successful first-in-human study in February 2019, may put the RaniPill ahead of the MIT/Novo Nordisk team’s LUMI capsule. The growing competition between these two groups will certainly be one to watch over the coming years.”