Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced progress with its clinical device performance study plan, evaluating the device function and safety of its Drug Delivery System (DDS) capsule.
Progenity’s first clinical device performance study evaluated the safety and tolerability of its DDS capsule and validation of the device’s localization and delivery function in healthy volunteers. The DDS capsule was ingested orally and after localization, it released a saline solution payload that included radioisotopes. Scintigraphic imaging was used to indicate device localization and payload delivery to the lower GI tract. The DDS capsule was well tolerated and the study demonstrated the ability to accurately identify entry into the colon in 10 out of 12 subjects, trigger release of a liquid payload, and achieve pan-colon distribution with no devices deploying before entering the colon.
“Having completed a successful study in healthy volunteers, we are now recruiting patients with active ulcerative colitis to continue evaluating the performance of our clinical device,” said Adi Mohanty, Chief Executive Officer of Progenity. “These studies are important steps toward our goal of initiating a therapeutic intervention trial for our PGN-600 program to evaluate delivery of therapeutics directly to the site of disease in patients suffering from ulcerative colitis, and if we are able to establish accurate delivery in ulcerative colitis, the platform should also be applicable for localized delivery of other drugs.”
The follow-on study design will mirror that of the first study, evaluating the delivery of an imaging agent to the colon using the DDS device, and will be conducted in patients with active ulcerative colitis. This in-patient study will be conducted at the Scintipharma research unit in Lexington, Kentucky. Enrollment is open to patients 18-75 years old with active ulcerative colitis. People who are interested in participating can send a message to clinical.trials@progenity.com to obtain information about the study.
