Progenity has begun a phase 1 clinical trial of its ingestible and self-guided drug delivery device. The study will assess the device’s gastrointestinal tolerability and ability to deliver a payload to the colon.
Ultimately, Progenity wants to use the capsule to deliver bolus doses of therapeutic compounds to a targeted part of the gastrointestinal tract. The idea is to deliver high doses of the therapeutic agent to target cells without causing the side effects associated with giving large quantities systemically. In doing so, Progenity thinks it can improve the treatment of diseases such as ulcerative colitis.
The clinical trial marks an early step toward that goal. Investigators will enroll 12 healthy volunteers in three dosing cohorts to assess the effect of a single dose. The capsules will carry a saline solution loaded with radioisotopes to enable Progenity to assess the accuracy of drug delivery.
“This research is a significant step in our efforts toward improving the management of ulcerative colitis, where therapy is often challenged by the inability to achieve sufficient drug concentrations at the site of disease without incurring dose-limiting side effects,” William Sandborn, M.D., a University of California, San Diego professor who has received consulting fees and other payments from Progenity, said in a statement.
The clinical trial continues the evolution of Progenity beyond its traditional focus on molecular tests for fertility and cancer risk. Progenity has established drug delivery technologies to support the expansion, setting it up to develop targeted therapies for the treatment of gastrointestinal disorders as well as other oral biologics.
So far, Progenity has said it is using the technology to create liquid formulations of TNF inhibitor Humira and JAK inhibitor Xeljanz. Both candidates are in development as treatments for ulcerative colitis.