SAN DIEGO—At the most recent Digestive Disease Week event, the biotech company Progenity presented posters detailing promising results of studies into the utilization of ingestible technologies to monitor, diagnose and treat gastrointestinal disorders. The ingestible micro-bio electronic device (IMBED) technology, sometimes referred to as an “intelligent pill,” is already transforming healthcare, attracting research and investment as it racks up 19-percent growth year over year, the company says.
In the simplest terms, IMBEDs are small devices made of biologically safe materials that can gather information about their environment, transmit data to a compatible receiver and potentially deposit precision doses of medicine exactly where it will be of most benefit. Subhra Pradhan, in her January article in Prescouter, describes IMBEDs like this: “They are ingestible electronic devices, roughly the size of a medicine capsule, composed of biocompatible materials that make up a power supply, microprocessor, controller, sensors, etc., giving the device the ability to telecommunicate for use in the healthcare industry for disease diagnostics and monitoring.”
For Progenity, the company’s goal is to transform healthcare toward more precise and personal diagnostics and treatment. They saw a vast unmet need in the gastrointestinal space, both for a better assessment tool and for better therapies. According to Dr. Mitchell Lawrence Jones, vice president of translation and clinical development at Progenity, it is time to move beyond using drugs developed to treat other conditions for GI issues, and to move beyond the current threshold of 15-percent efficacy above placebos.
“We aim to improve GI diagnosis and treatment through internal diagnostic tests,” he says. “We think of our capsule as a non-invasive tool for accessing the small intestine, which has traditionally been a ‘black box’ for the body, Our technology enables collection of biomarkers unique to that methodology that can’t be obtained from a blood sample or a fecal sample. Today, patients must go on a diagnostic odyssey [to understand symptoms], using scopes, ultrasounds, blood tests and more. None of these are adequate as the gold standard for GI conclusions.”
Progenity’s capsule, still in preclinical investigation in animal subjects, demonstrates several distinct advantages. Once the patient swallows the capsule, it will be in the body between 24 and 48 hours, depending on the individual, and is able to self-locate by emitting a light that reflects off of the anatomy of the gut to determine its location. The capsule introduces a fluorometric assay that can count bacteria in the gut in order to diagnose small intestine bacterial overgrowth, gather information on the state of inflammation in a patient with Crohn’s disease, or assess difficult-to-reach areas to monitor colorectal cancer, for example. The body expels the capsule through normal digestion, but only after collecting critical information.
On the therapeutic side of the capsule’s utility, the IMBED can self-locate and place a very specific dose of the right drug to the exact spot where it will be most efficacious. This topical application directly to the site fo the disease, as a liquid soluble drug, reportedly maximizes bioavailability compared to an injected dose, which can cause systemic toxicity. It can deliver to the surface of the mucosa of the bowel, which limits systemic exposure and curtails the immune-suppressant action of some drugs that can be dangerous at the wrong injected dose.
In addition, it allows for precision dose rationale and for multiple drugs to be delivered in synergistic dosing. The hope at Progenity is that eventually their capsule will be able to deliver precision dosing, but also combination therapy to the exact location to incur benefits.
Progenity is working in conjunction with the FDA, receiving critical advice and assistance in preparing for early human trials. They expect to submit an Investigational New Drug application soon and will proceed along the regulatory pathway, submitting biologics and exploring options as an innovator, or approval on the platform itself. They are also exploring the development and manufacture of the very drugs that the capsule can deliver.
“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,” stated Harry Stylli, CEO, chairman and a co-founder of Progenity. “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. Progenity is also developing and manufacturing its own pipeline of drugs with established efficacy and safety profiles in IBD. 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.”
IMBEDs are already in use in fascinating ways. Australian scientists have demonstrated the first pilot human trial on gut gas-sensing digital pills, providing some powerful new insights into gut activity which could revolutionize our understanding of the gut, gastrointestinal biomolecules, food retention time, digestion, food absorption or lack thereof, microbiome composition and much more, all in real time and in a noninvasive manner. Other companies are using IMBEDs to monitor drug compliance, alerting doctors or caretakers when someone has neglected to take their medication or when they might be at risk for an overdose. Also, an Israeli company is testing an IMBED instead of having an invasive colonoscopy.