Benzinga | Nov 6, 2020 07:41AM EST

Progenity PR Highlights Preclinical Data On Its Oral Drug Delivery System In Targeting The Colon

SAN DIEGO, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, is pleased to announce positive preliminary preclinical data regarding the performance of its oral drug delivery system (DDS). The DDS capsule uses a proprietary autonomous localization technology designed to identify the ileal/ileocecal region of the GI tract. Because the DDS localization technology is based on anatomy, it is designed to resist variability in physiological conditions like pH, motility and bacteria.

The study consisted of administration of a fully functional DDS device containing a mixture of acetaminophen and sulfasalazine in a canine animal model. The study endpoints were device function as determined by evaluation of the data from the recovered capsules and the pharmacokinetic (PK) results of the acetaminophen and 5-aminosalicylate drug products delivered using the DDS. When ingested orally, acetaminophen is typically absorbed rapidly along the entire length of the GI tract, while sulfasalazine is a prodrug that is metabolized by intestinal bacteria, resulting in the release of sulfapyridine and 5-aminosalicylate mainly in the large intestine where bacterial concentration is elevated. Progenity is pleased to report that all devices met the study endpoints, and the PK results suggest that drug was released in the large intestine. In addition, no adverse events were observed.

"Ulcerative colitis is poorly managed with current therapeutics, in part due to the inability to get sufficient drug concentrations at the site of disease without side effects. We believe the DDS platform and PGN-001 and PGN-600 have the potential to significantly improve patient outcomes by producing high drug concentrations locally at the site of disease to improve efficacy while limiting systemic exposure to ensure safety," said William Sandborn MD, Chief of the Division of Gastroenterology and Director of the Inflammatory Bowel Disease Center at the University of California San Diego.

Progenity has two lead drug-device candidates utilizing the DDS technology, PGN-001, a high-concentration formulation of adalimumab, and PGN-600 a liquid formulation of tofacitinib, both under development for the treatment of ulcerative colitis. The company has previously observed through intracecal catheter preclinical colitis models, which are designed to mimic the localized delivery of the DDS, both local delivery of drug product and reduction in systemic exposure when compared to injection.

"These exciting data provide pre-clinical evidence that the DDS platform performed as intended and accurately targeted the colon. The technology is also designed to allow for delivery of different formulations, enabling further evaluation of formulations designed to improve stability, colonic coverage and tissue uptake. We expect to evaluate the function of the DDS in normal healthy human volunteers in the first quarter of 2021," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity.