San Diego-based Progenity is moving forward with its oral biologic drug delivery project, launching clinical trials in patients with ulcerative colitis.
The company's Drug Delivery System (DDS) is an ingestible capsule intended for targeted delivery of therapeutics for patients with inflammatory bowel disease (IBD). According to Progenity, once swallowed, the capsule is designed to autonomously identify when it has arrived at a specific location in the gastrointestinal tract and release a therapeutic dose at the site of disease.
According to Progenity, existing therapeutics can be less than ideal because they face challenges with delivering sufficient drug levels in the affected tissues. With positive results from an initial study in healthy volunteers, the company is now looking to include patients with active ulcerative colitis in the next phases of their studies.
The initial study evaluated the tolerability and safety of the DDS capsule. Volunteers were given a capsule to take orally that then released a saline solution with radioisotopes. Imaging later confirmed that DDS capsule safely reached the lower GI tract in 10 out of 12 subjects, and successfully released the liquid. None of the DDS capsules triggered release before reaching the intended localization either.
“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,” concluded Adi Mohanty, CEO of Progenity.
Enrollment is open to patients 18-75 years old with active ulcerative colitis. People who are interested in participating can send a message to [email protected] to obtain information about the study.
