SAN DIEGO–(BUSINESS WIRE)–Progenity,
Inc., a privately held biotechnology company developing proprietary
precision medicine solutions across genomic/epigenomic, proteomic, and
microbiomic diagnostic and therapeutic platforms, this week announced
results from three studies that represent potential breakthrough systems
for diagnosing, treating, and monitoring digestive diseases through ingestible
technologies.
Proof-of-concept studies in both human and pre-clinical models showed
Progenity’s ingestible diagnostic capsule platform is capable of
autonomous location-based sampling, biomolecular analysis, and real-time
wireless communications for assessing and monitoring gastrointestinal
health. Further, data from two preclinical proof-of-concept studies
looking at direct topical delivery of monoclonal antibodies (mAbs) to
the lining of the gut versus systemic administration with an injection,
demonstrate in pre-clinical models the potential for improved efficacy
and safety in the treatment of inflammatory bowel disease (IBD). The
data from these studies were presented at Digestive Disease Week 2019 in
San Diego, California, May 18-21.
“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 of the Board, and a founder
of Progenity.
“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. 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,” stated
Stylli.
Development of an Ingestible Diagnostic Capsule to Monitor
Gastrointestinal Health
Progenity presented results of a study evaluating the function of a
system that includes an autonomous, swallowable diagnostic capsule for
in situ biomolecular detection. As a proof-of-concept, this system has
been designed to aid in the diagnosis and monitoring of small intestinal
bacterial overgrowth (SIBO). The system has three components: a capsule,
a wearable receiver, and analysis software. The capsule is a single-use
device swallowed by the patient. The capsule determines its location in
the digestive tract, collects a sample, and performs an onboard assay to
measure bacterial load. The results of the assay are wirelessly
communicated from the wearable receiver to the software for review by
the healthcare provider.
SIBO is a clinical condition associated with abnormally high bacterial
counts in the small intestine and symptoms such as diarrhea,
constipation, abdominal pain, distension, and bloating. SIBO is
under-diagnosed and significant limitations exist with currently
available diagnostic testing methods. Aspiration and culture of proximal
jejunal contents is invasive, costly, and has low reproducibility.
Breath testing is noninvasive but has poor sensitivity and specificity
and lacks standardization of methodology. As a result, patients with
SIBO are poorly served. Progenity’s diagnostic capsule system represents
the potential for a powerful new tool to aid in the diagnosis of SIBO,
with the sensitivity and reproducibility of the aspirate and culture
method combined with the noninvasive nature of breath testing.
The system has undergone a series of validation and verification tests
including full Clinical Laboratory Standards Institute (CLSI)
verification of the assay and a clinical evaluation of the localization
algorithm. The assay and call algorithm continue to be evaluated ex vivo
in an ongoing prospective human clinical trial.
Direct Topical Delivery of Monoclonal Antibodies Could Improve
Treatment of IBD
Inflammatory bowel disease (IBD) is characterized by a disproportionate
inflammatory response in gastrointestinal tissues, leading to damage and
clinical symptoms. There is an urgent need to achieve higher rates of
clinical response, remission, and mucosal healing in IBD. Several
therapeutic monoclonal antibodies (mAbs) have revolutionized the
treatment of these disorders, but despite their potency, have provided
limited long-term efficacy in patients due to lack of response and
chronic complication.
Two posters presented by Progenity hypothesize that improved response
can be achieved via direct topical delivery of mAbs to the site of
disease by providing concentrations sufficient to drive improved
efficacy while reducing the systemic toxicity that is often associated
with these agents when administered systemically. The posters describe
results from comparative studies in which mouse models of induced
chronic colitis 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, these findings provide a proof-of-concept
for direct topical delivery of therapeutic antibodies and suggest the
potential for improved efficacy in the treatment of IBD.
For more information about these studies please visit progenity.com/research.
About DDW
Digestive Disease Week® (DDW) is the largest international gathering of
physicians, researchers, and academics in the fields of
gastroenterology, hepatology, endoscopy, and gastrointestinal surgery.
Jointly sponsored by the American Association for the Study of Liver
Diseases (AASLD), the American Gastroenterological Association (AGA)
Institute, the American Society for Gastrointestinal Endoscopy (ASGE),
and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes
place May 18-21, 2019, at the San Diego Convention Center. The meeting
showcases more than 5,000 abstracts and hundreds of lectures on the
latest advances in GI research, medicine, and technology. More
information can be found at www.ddw.org.
About Progenity
Progenity, Inc., is a privately held biotechnology company with the
mission of transforming healthcare to be more precise and personal. The
company is translating innovation into precision medicine through
diagnostic and therapeutic development platforms based on
genomics/epigenomics, proteomics, and microbiomics. These platforms feed
an R&D pipeline of innovative products designed to improve patient
outcomes in prenatal and perinatal healthcare settings, oncology, and
gastroenterology. Progenity’s ultimate vision is to make precision
medicine a reality by both diagnosing disease at its source and treating
it with targeted therapies developed by the company. Progenity is
headquartered in San Diego, California. For more information on how
Progenity is helping clinicians and patients prepare for life, please
visit www.progenity.com.
Contacts
Media Contact
Nicole Goelz
CG Life
ngoelz@cglife.com
(858)
457-2436
Investor Contact
IR@progenity.com