Progenity is working to address significant unmet needs and support these affected patient populations with proprietary ingestible technologies that diagnose and treat at the site of disease, with the goal of improving patient outcomes through precise healthcare.
Targeted GI Sampling
Progenity’s GI characterization platform is being developed to enable the collection, preservation, and analysis of samples from previously inaccessible parts of the small intestine. The core element of this platform is an ingestible capsule device. Once swallowed by a patient, the capsule device autonomously identifies designated locations in the GI tract, captures samples, and preserves analytes such as metabolites, proteins, and nucleic acid biomarkers. The analytes are then recovered from the device and evaluated using Progenity’s analytics and bioinformatics technologies.
This platform has broad application potential, including characterization of disease through detailed assessment of the small intestinal epithelial interphase, which could lead to identification of diagnostic biomarkers and therapeutic targets and pathways.
Additionally, the platform may enable development of early pharmacodynamic evidence for drug efficacy and prediction of therapeutic response, which, if successful, should increase the efficiency of drug development. The GI characterization platform is currently supporting the development of a number of Progenity diagnostic and therapeutic products.
Ingestible GI Diagnostics
Progenity’s ingestible diagnostic platform is being developed to collect and analyze mucosal fluid while in transit through the intestines, transmitting analysis data to a wearable device, with no ingestible device recovery needed and no sample to send to the lab. Onboard assays will perform pre-specified analysis including measurement of microbes, proteins, nucleic acids, and pharmaceuticals.
Progenity’s ingestible onboard assays are being developed to aid in the diagnosis of numerous GI disorders. This platform technology has the potential to become the gold standard for noninvasive evaluation of the intestinal milieu, enabling a more personalized approach to patient management. Progenity is developing a broad test menu for this diagnostic platform, including tests for irritable bowel syndrome (IBS), nonalcoholic steatohepatitis (NASH), colon cancer, and inflammatory bowel disease (IBD).
Current therapeutics offer poor efficacy in many IBD cases. GI tract inflammation and lesions contribute to this poor efficacy by accelerating drug loss into the GI tract. Achieving higher drug concentrations in the diseased tissues may lead to improved drug response and remission rates in patients suffering from IBD.
Progenity’s targeted delivery platform offers the ability to accurately localize and deliver drugs at the site of disease in the GI tract. This will enable the necessary therapeutic tissue dose, improving efficacy while limiting systemic exposure and side effects. Candidate drugs for this form of delivery are those that predominantly act in the intestinal tissues, but currently have limited efficacy because of systemic toxicities. With lower systemic absorption, the technology is likely ideal for use in combination therapies to increase efficacy without increasing adverse effects.
Biologic drugs have become standard of care for a variety of diseases including rheumatoid arthritis, psoriasis, diabetes, Crohn’s disease, ulcerative colitis, and many cancers. These biologics are generally administered via subcutaneous or intravenous injection, given their poor uptake when delivered orally. However, the vast majority of patients prefer oral delivery, which is a significant barrier to patient compliance with injectables.
Progenity’s ingestible therapeutic products under development are designed to enable convenient oral systemic delivery of large-molecule biologics. The product utilizes technology that protects the drug from acid and proteolytic enzyme degradation in the upper GI tract, and delivers the drug directly into the tissues of the small intestine, where it can be absorbed systematically. Once absorbed into systemic circulation, biologic drugs act with the same pharmacodynamics as when delivered by subcutaneous or intravascular injection.
The potential applications for this technology extend beyond GI diseases and are compatible with several existing FDA-approved therapeutics which currently require a parenteral route of administration.