Organovo Presents FXR314 3D Human Tissue Model Findings That Show Improved Epithelial Barrier Function and Fibrosis Reduction at Crohn’s and Colitis Congress
25 Gennaio 2024 - 2:05PM
Organovo Holdings, Inc. (Nasdaq: ONVO), a clinical stage
biotechnology company focused on developing FXR314 in inflammatory
bowel disease (IBD), including ulcerative colitis, based on
demonstration of clinical promise in three-dimensional (3D) human
tissues, today announced the presentation of preclinical data
related to the company’s FXR314 development program in its
proprietary 3D human tissue models of Crohn’s disease and
ulcerative colitis at the Crohn’s and Colitis Congress being held
January 25-27, 2024 in Las Vegas, Nevada.
FXR314 is a clinical-stage potent, selective,
orally administered non-bile acid FXR agonist being developed as a
novel therapeutic approach for IBD.
“There is a critical need for novel approaches
to treat inflammatory bowel disease (IBD) that extend beyond
modulating the immune response targeted by current pharmacological
therapies. These data underscore the potential of FXR314 as a
unique treatment approach to IBD given its demonstrated
multifaceted activity profile, especially in directly improving the
intestinal barrier function and controlling fibrosis,” said Dr.
Fabrice Piu, Vice President, Research & Development. “The
Crohn’s and Colitis Congress is a unique opportunity to demonstrate
this potential among key thought leaders in the field and as we
continue to drive our program forward.”
The presentation highlights preclinical data
characterizing the activity of FXR314 in 3D models of human Crohn’s
disease and ulcerative colitis. FXR314 broadly improved measures of
epithelial barrier function in a subset of donors, and fibrotic
markers in all Crohn’s disease donors. In ulcerative colitis,
FXR314 improved epithelial barrier function and fibrotic activity
in all donors.
“Organovo’s primary multicellular 3D human IBD
models constitute a powerful tool to more accurately predict the
relevance of specific targets and assess the efficacy of
therapeutic candidates. We strongly believe these results increase
the probability of success with FXR314 when conducting IBD clinical
trials, due to its demonstrated comparability to known disease,”
added Keith Murphy, Organovo’s Executive Chairman.
Organovo’s current development program for
FXR314 focuses on inflammatory bowel disease, where the drug’s
differentiated mechanism of action, as highlighted in Organovo’s
recently provided mechanism of action video at
https://organovo.com/about/, provides substantial promise that the
drug’s impact will strongly complement the biology of other
successful drugs in ulcerative colitis and Crohn’s disease.
Organovo plans to begin enrollment for a proof-of-concept Phase 2
ulcerative colitis study in 2024, with targeted completion in 2025.
The drug’s additional promise in liver fibrosis and NASH makes it a
strong candidate for development in that.
Details of the presentation at the Crohn’s and
Colitis Congress in Las Vegas are shown below:
Title: |
|
Evaluation of the clinical stage FXR agonist FXR314 in human
primary cell 3D models of Crohn’s disease and ulcerative
colitis |
Presenter: |
|
Dr. Fabrice Piu, Vice President Research & Development |
Date: |
|
Friday January 26, 2024 at 3 PM (Pacific) |
|
|
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About Organovo
Organovo is a clinical stage biotechnology
company that is developing drugs that are demonstrated to be
effective in three-dimensional (3D) human tissues as candidates for
drug development. The company’s lead molecule, FXR314, is on the
path for Phase 2 investigation in inflammatory bowel disease and
has potential application in metabolic liver disease and oncology.
The company has proprietary technology used to build 3D human
tissues that mimic key aspects of native human tissue composition,
architecture, function and disease. For more information
visit Organovo's website at www.organovo.com.
Forward Looking Statements
Any statements contained in this press release
that do not describe historical facts constitute forward-looking
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. Any forward-looking statements
contained herein are based on current expectations, but are subject
to a number of risks and uncertainties. These risks and
uncertainties and other factors are identified and described in
more detail in the Company’s filings with the SEC, including
its Annual Report on Form 10-K filed with the SEC on July
14, 2023, as such risk factors are updated in its most recently
filed Quarterly Report on Form 10-Q filed with the SEC on November
9, 2023. You should not place undue reliance on these
forward-looking statements, which speak only as of the date that
they were made. These cautionary statements should be considered
with any written or oral forward-looking statements that the
Company may issue in the future. Except as required by applicable
law, including the securities laws of the United States, the
Company does not intend to update any of the forward-looking
statements to conform these statements to reflect actual results,
later events or circumstances or to reflect the occurrence of
unanticipated events.
Contact
Core Investor Relationspr@coreir.com
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