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Ingestible Technologies for Diagnosis of Gastrointestinal Disorders

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Progenity is applying a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics, to its development of a novel pipeline of precision medicine product candidates designed to provide solutions for gastrointestinal disorders. This pipeline includes diagnostic applications, targeted drug delivery in the GI tract at the site of disease, and the oral delivery of biologics. These product candidates, if successfully developed, have the potential to address unmet healthcare needs by more precisely identifying and treating chronic GI diseases, such as small intestinal bacterial overgrowth, or SIBO, and inflammatory bowel disease, or IBD.

Technology Networks
talked with Progenity’s Christopher Wahl, MD, MBA and vice president of strategy and operations to get his insights into the research and work being done specifically with Progenity’s novel ingestible lab-in-a-capsule, PIL Dx.

What research and development has led up to this point?

Christopher Wahl (CW):
We are developing the PIL Dx diagnostic capsule to analyze samples from specific locations of the GI tract. Once ingested, the capsule is designed to communicate wirelessly with a wearable RF receiver to report on status and other operational data. We have several ingestible capsule technologies in development, and our most advanced investigational PIL Dx capsule is the Smart Capsule Bacterial Detection System (SCBDS), which was the subject of our recent American College of Gastroenterology (ACG) Conference oral presentation. The SCBDS capsule includes an integrated assay which is designed to measure with high sensitivity the change of a metabolically active substrate that correlates with the amount of live bacteria in the small intestine.

Currently, the SCBDS capsule has undergone a series of validation and verification tests of the various subsystems and evaluations of the localization algorithm. The autonomous localization technology is based on a proprietary LED light and photodetector sensor array that detects reflected light in the GI tract and uses a proprietary algorithm to determine anatomical locations of interest, for example, the pyloric and ileocecal transition. In three clinical studies evaluating the localization technology, localization of the capsule was confirmed either by CT scan or scintigraphy. In addition, these studies proved the performance of the communication subsystem as data was transmitted to a wearable receiver.

There has also been significant research and development to date on the bacterial concentration assay. The positive data and progress to date led to the clinical study presented at the ACG conference.

Progenity presented data on PIL Dx at the American College of Gastroenterology (ACG) 2020; can you tell me more about the multi-site study referenced in the presentation?

The primary objective of the
multi-site clinical study presented at the ACG conference was to examine the in vitro accuracy of the SCBDS bacterial concentration assay against the standard clinical measurement of total bacterial count from duodenal aspirate obtained via endoscopy. The study enrolled 54 patients suspected of SIBO across two sites and 12 patients undergoing upper endoscopy for all indications at one site for a total of 66 patients across the three sites. The primary analysis was the agreement between the SCBDS assay and the standard total bacterial count at identifying bacterial concentrations greater than 10^5 colony forming units (CFUs) per milliliter of intestinal fluid, which is the generally accepted definition of SIBO. We are pleased to report that across the 66 patients, there was 94% agreement between the SCBDS assay and total bacterial count.

Tell us more about SIBO, how it is currently diagnosed and limitations of these approaches?

One other area that is extremely important is the unmet need in evaluating suspected SIBO patients. SIBO is characterized by symptoms such as bloating, abdominal pain, and diarrhea that can be very debilitating and go undiagnosed for years. According to studies in the American Journal of Gastroenterology and the Gastroenterology Journal there are over 100 million patient visits in the United States annually with symptoms that may be suggestive of SIBO. The current standard of care to diagnose SIBO is a duodenal or jejunal aspirate obtained via an invasive upper GI endoscopy which is then transported to a microbiology laboratory for culture, with results generally available several days later. There is high variability in the technique for the aspiration and culture from laboratory to laboratory, leading to inconsistent results between laboratories. This current standard of care is not only costly and time consuming, but it also requires sedation and is highly invasive, thus making our capsule technology a potentially attractive alternative.

In addition, there are various breath tests which rely on the detection of hydrogen or methane as a proxy for bacterial presence in the small intestine. These breath tests suffer from lack of sensitivity and specificity which limit their effectiveness. The importance of novel tests for SIBO that overcome some of these limitations may be the reason that the oral presentation by Dr Rao received the
Small Intestine Category Award.

In addition to the oral presentation, we also had a poster
accepted at AGC based on market research and expert assessment that addressed the unmet need in SIBO and the potential for the SCBDS to fill this need. The market research consisted of qualitative and quantitative research that involved 100 gastroenterologists (GIs) in total. The research found that the most common diagnostic workup for SIBO is breath test and empiric antibiotic therapy, but most GIs are unsatisfied or very unsatisfied with current diagnostics. The main limitations identified were poor accuracy and difficulty interpreting results. The SCBDS product concept was viewed favorably with the potential to replace both breath test and endoscopy and aspiration as the preferred test for suspected SIBO patients.

We believe the SCBDS, if successfully developed and approved or cleared, has the potential to become the standard of care for evaluating suspected SIBO patients.

What challenges does Progenity face moving forward with PIL Dx?

The PIL Dx will face standard development challenges as a regulated medical device that will undergo the FDA de novo pathway similar to other novel ingestible devices. This will include sufficiently powered clinical studies and appropriate assay validation.

In addition, Progenity will need to work closely with the medical community to continue growing awareness of SIBO. As mentioned previously, there are over 100 million patient visits in the United States annually with symptoms that may be suggestive of SIBO. However, SIBO is substantially under-diagnosed in part due to limited but growing awareness in addition to significant limitations of currently available testing methods. As a result, patients with SIBO are poorly served. We are committed to improving the outcomes of these patients and will therefore work to support awareness and education around SIBO.

What's the next step?

We are extremely excited about the next steps for this technology. Our team is in the process of transferring the SCBDS design to manufacturing and preparation for first clinical evaluation in the second half of 2021. We are also progressing towards assay validation for the SIBO bacterial concentration assay.

In what other areas could this technology be used?

The technology contains an on-board fluorometric assay system that could be capable of measuring a range of analytes including inflammatory cytokines, drug levels, microbes, nucleic acids and other metabolites. This enables the potential for numerous other applications such as for early tumor detection and disease characterization and subtyping, and disease activity monitoring for conditions such as IBD.