Progenity starts oral biologic trial in ulcerative colitis after coming through early clinical test

Progenity is advancing its oral biologic drug delivery project using the successful completion of its study in healthy volunteers as a launchpad for a clinical trial in patients with ulcerative colitis. 

San Diego-based Progenity has ramped up its drug delivery ambitions over the past year or so, in which time it has presented data on an oral Humira, secured the support of IBD Ventures Fund and inked a partnership with Ionis Pharmaceuticals. Now, Progenity has wrapped up a trial of its oral drug delivery device, teeing it up to move deeper into the clinic. 

The study in healthy volunteers “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,” Progenity said. The study researchers loaded a saline solution with radioisotopes and used imaging to locate the device and its payload.

With the study finding the device to be well tolerated, Progenity is now running a trial in patients. The new clinical trial will mirror the design of the study in healthy volunteers but enroll patients with active ulcerative colitis. Progenity CEO Adi Mohanty set out what the trials mean for the project.

“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,” Mohanty said in a statement.

Progenity’s delivery system consists of a capsule that is designed to release bolus doses of therapeutic compounds to a targeted part of the gastrointestinal tract, thereby avoiding the side effects associated with systemic administration.