The Gemicel ODS presentation is a complex capsule-in-capsule (CIC) design. The outer capsule contains a therapeutic payload and a smaller inner capsule, which contains a second therapeutic payload. Each capsule is engineered with specialized polymeric coatings to facilitate drug release in two separate targeted regions of the GI tract.
The Gemicel ODS technology fundamentally leverages biological parameters that vary in different regions of the GI tract, such as changes in acidity, or pH. Following oral administration, Gemicel transits through the GI tract where it releases its first therapeutic payload and an intact inner capsule at a first target region of the GI tract based on pH. The inner capsule then continues to transit through the GI tract where it releases a second therapeutic payload at a second target region of the GI tract based on a different pH. The Gemicel ODS technology makes 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 Biosciences completed a human clinical study of Gemicel ODS which confirmed successful delivery of dual bolus doses of therapeutics to specific locations in the lower GI tract, including the ileum and ascending colon. The study used radioisotope-based scintigraphy to precisely image the drug delivery properties of Gemicel ODS. Targeted delivery to the lower GI tract has advantages for a number of therapeutic indications.
The Gemicel targeted delivery system 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 ODS technology is available for licensing. For more information, contact our business development team at BD@assemblybio.com.