Precision Medicine company Progenity, a developer of both diagnostic and therapeutic platforms, announced results from three studies that represent potential breakthrough methods for diagnosing, treating, and monitoring digestive diseases through ingestible technologies.
The studies, which encompass both human and preclinical models, showed that the company’s ingestible diagnostic capsule provided autonomous location-based sampling, biomolecular analysis, and real-time wireless communications for gastrointestinal health applications. Two preclinical proof-of-concept studies also demonstrated the potential for improved efficacy and safety in the treatment of inflammatory bowel disease (IBD) via direct topical delivery of monoclonal antibodies (mABs) to the lining of the gut, versus systemic administration with an injection.
The data from these studies were presented this week at Digestive Disease Week (DDW) 2019 in San Diego.
“In our continued efforts to make healthcare more precise and personal, we are developing potentially the first platform technology capable of functioning as an ingestible digital fluorometric laboratory with a range of possible assays for gastrointestinal, metabolic, and microbial disorders,” said Harry Stylli, CEO, chairman, and a founder of Progenity in a press release.
Progenity has developed an autonomous, diagnostic capsule that a patient ingests for in situ biomolecular detection and monitoring of small intestinal bacterial overgrowth (SIBO). SIBO is a clinical condition associated with abnormally high bacterial counts in the small intestine. Its symptoms included diarrhea, constipation, abdominal pain, distension, and bloating. SIBO is under-diagnosed due to a lack of reliable diagnostic testing methods. Progenity believes its diagnostic capsule system could become a more accurate method to aid in the diagnosis of SIBO.
The single-use capsule can determine its location in a patient’s digestive tract, collect a sample and perform on on-board assay that measures bacterial load. Results of the assays are transmitted from a wearable receiver to a software package that provides information to a clinician for use in treating that patients.
In addition to the proof-of-concept study for its ingestible capsule, Progenity also presented two posters at DDW from preclinical studies showing whether IBD treatments using a direct topical delivery of mAB therapies to the site of the disease in sufficient concentrations to improve treatment efficacy while simultaneously reducing the toxicity is a viable treatment option versus systemic delivery of the mAbs.
In these studies, researchers used mouse models of induced chronic colitis which were administered mAbs with either a systemic injection into the body cavity (intraperitoneal–IP) or direct topical application to the lining of the large intestine through a surgical portal (intracecal–IC). Results showed direct topical (IC) administration was more efficacious when compared to systemic (IP) delivery of anti-TNFα antibody and anti-α4β7 antibody in mouse models of acute colitis. Taken together, the findings show show the potential for direct topical delivery of therapeutic antibodies to improve the efficacy of IBD treatments.
“These platform technologies are intended to directly address challenges clinicians face in diagnosing gastrointestinal disorders and treating patients with therapies that can result in low response rates and high toxicity,” Stylli noted in the press announcement. “Our proof-of-concept studies demonstrate great promise that these technologies can be used in a variety of applications to greatly improve the ability of clinicians to diagnose, treat, and monitor digestive diseases. We believe our proprietary platform will help improve the therapeutic safety and efficacy of currently available therapies, and their combinations, for the treatment of IBD and other diseases.”