Gastrointestinal Health

Targeted therapeutics and diagnostics (in development)


Focused on diagnosing and treating
GI diseases at the site of disease.

A potentially disruptive platform & robust pipeline for GI health

Woman stirring cup of coffee.

Diseases involving the gastrointestinal (GI) tract affect hundreds of millions of people worldwide. These disorders range from inflammatory bowel diseases (IBD), various form of hepatitis, and colon cancer, to functional disorders like irritable bowel syndrome and small intestinal bacterial overgrowth.

We are working to address unmet needs for these patients with ingestible technologies that could transform the diagnosis and treatment of GI disease.

The clinical dilemma

  • Achieving therapeutic drug levels with systemic delivery of medication can be difficult, due to safety concerns.
  • Current GI diagnostics are either invasive (e.g., endoscopy, surgery, biopsy) or imprecise (e.g., breath testing).
  • Invasive procedures and technologies make some GI research challenging.

Our approach

Noninvasive, direct access to the GI tract could help to:

  • Replace systemic drug therapy with targeted, direct-to-site drug therapies to improve treatment efficacy and safety
  • Obtain samples from the GI tract without invasive endoscopy procedures, to better diagnose GI diseases
  • Provide a unique tool to discover novel biomarkers and drug targets
3D render of the Progenity DDS.

GI-targeted therapeutics

IBD affects 1.8 million patients in the U.S. alone. Existing therapeutics have extremely poor efficacy due to insufficient drug concentrations at the site of disease. Localized, topical drug delivery to the colon has potential to improve outcomes in IBD, through increasing efficacy and safety.

We are developing therapeutics that combine Progenity-owned investigational formulations of approved drugs with our Drug Delivery System (DDS). The DDS features proprietary localization technology that enables precise drug delivery at the site of disease in the GI tract. Our lead candidates are PGN-001 (colon-targeted adalimumab) and PGN-600 (colon-targeted tofacitinib), in development initially for ulcerative colitis. Robust preclinical data across multiple animal models and clinical studies have shown the potential of targeted delivery.

PGN-600
Tofacitinib + DDS
PGN-001
Adalimumab + DDS
Reduced developmental risk by using approved drugs
More drug to the site of disease shows promising efficacy profile
Less drug delivered systemically may lead to improved safety profile
Unique combinations designed to yield promising efficacy profile

Key milestones

May 2021

  • Recipient of the Crohn’s and Colitis Foundation IBD Ventures development grant

Q4 2021

  • Topline results from clinical pharmacokinetic/pharmacodynamic study of adalimumab in ulcerative colitis patients

2022

  • Initiating first clinical study evaluating the pharmacokinetics/ pharmacodynamics of therapeutics delivered with DDS

Ingestible diagnostics

We are developing lab-in-a-capsule technology that can autonomously sample the GI environment to help inform diagnosis of gastrointestinal disorders, without the need for invasive procedures.

3D render of the Progenity SCBDS.

PIL Dx: Progenity Ingestible Lab

The PIL Dx is a "point-of-care" ingestible diagnostic that is designed to autonomously locate, sample, measure, and transmit results. It has the potential to support fluorescent assays measuring bacteria, proteins, and drugs, plus additional detection modalities.

The first PIL Dx product under development is designed to detect bacteria in the small intestine to aid in the evaluation of small intestinal bacterial overgrowth (SIBO). There are over 100 million U.S. patient visits annually with symptoms suggestive of SIBO.

Possible additional applications of PIL Dx include:

  • Nonalcoholic steatohepatitis (NASH)
  • Colon cancer screening
  • IBD

How it works:

Ingest

The patient swallows
the ingestible capsule.

Localize, sample, and analyze

The PIL Dx device autonomously identifies designated locations in the GI tract. It collects and analyzes mucosal fluid in situ while moving through the intestine.

Transmit results

The capsule transmits results
to an external device.

Key milestones

Technology and data presented at the 2020 American College of Gastroenterology and 2019 Digestive Disease Week conferences
Excellent concordance between assay and reference standard of culture and plate count for identifying 105 CFU per mL
Full-function preclinical study planned and initiating clinical proof-of-concept study in 2021
3D render of the Progenity RSS.

RSS: Recoverable sampling & preservation system

The RSS capsule, currently in development, has been designed to autonomously identify locations in the GI tract and obtain samples at the site of disease. It has the capability to preserve analytes in real time, which could then be recovered from the capsule and analyzed, without the need for invasive endoscopy procedures. Data would then be generated through Progenity’s analytics lab and bioinformatics platform.

Possible applications include:

  • Biomarker sampling in the GI tract
  • Drug target identification
  • Noninvasive microbiome evaluation
  • Future key to GI therapeutic and diagnostic development

How it works:

Ingest

The patient swallows
the ingestible capsule.

Localize, sample, and preserve

The RSS device autonomously identifies designated locations in the GI tract. It collects a sample at the site of disease and preserves it for analysis.

Recover and analyze

Samples are recovered from
the device and analyzed.

Key milestones

Initiating clinical proof-of-concept study in Q2 2021
Initiating clinical study in 2021 evaluating GI biomarkers in patients with IBD to monitor disease progression and predict response to therapeutic intervention

Stay informed about gastrointestinal health

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