Targeted drug delivery to the lower gastrointestinal (GI) tract is difficult to achieve. Gemicel® is a novel dual release system designed to enable oral targeted delivery of biologics, including live biotherapeutics such as vegetative bacteria and bacterial spores, vaccines, complex macromolecules and genetic materials, as well as small molecules, to the lower GI tract.
The Gemicel technology leverages parameters that vary in different parts of the GI tract, including changes in acidity, or pH. Gemicel can be targeted to release its therapeutic payload in specific sections of the GI tract based on their characteristic pH levels. The Gemicel capsule shell is constructed to dissolve at the predetermined pH of its target region, thereby delivering its therapeutic payload as a single bolus dose. Gemicel capsules also have inner and outer layers that can be engineered to dissolve at different pH levels, making it possible to use a single capsule to deliver two doses of a therapeutic to different locations in the GI tract, or to deliver two different therapeutics to different locations.
Assembly completed a human clinical study of Gemicel that was presented at a scientific meeting in early 2016. The study used radioisotope-based scintigraphy to precisely image the drug delivery properties of Gemicel. It confirmed that Gemicel can successfully deliver bolus doses of therapeutics to specific locations in the lower GI tract, including the ileum and ascending colon. Targeted delivery to the lower GI tract has advantages for a number of indications, including for treatment of recurrent C. difficile infection.
Gemicel's targeted delivery capabilities can serve as an enabling platform technology for other novel microbiome-based therapies, as well as for oral vaccines, genetic materials and small molecule agents. Assembly has also confirmed that scale-up and manufacture of the Gemicel technology is efficient and cost-effective.
The Gemicel delivery technology is available for licensing. For more information, contact our business development team at BD@assemblybio.com.