Organovo Highlights FXR314 Combination Therapy Potential and Plan
08 November 2023 - 2:05PM
Organovo Holdings, Inc. (NASDAQ: ONVO), a clinical stage
biotechnology company that is focused on developing FXR314 in
ulcerative colitis and inflammatory bowel disease (IBD), based on
demonstration of clinical promise in three-dimensional (3D) human
tissues as well as strong preclinical data, today announced its
intention to study combination therapy in inflammatory bowel
disease and release data in calendar Q3 2024. The Company believes
that the data it can generate can be powerful in establishing a
strong use case for FXR314 in patients, and provide support for
collaborations with major pharmaceutical companies currently
offering IBD treatments.
The differentiated mechanism of action of
FXR314, as highlighted in Organovo’s recently provided mechanism of
action video at http://organovo.com, provides substantial promise
that the drug’s impact will strongly complement the biology of
other successful drugs in the space, e.g. TNF-alpha inhibitors
(such as Humira), IL-12/23 inhibitors (such as Stelara), and JAK
inhibitors (such as Xeljanz). The promise of combination therapy in
this space is great, as all of these therapies have impactful
safety signals. The ability to enable dosing half or less of the
typical dose of these drugs, enabled by a combination with FXR314,
could substantially reduce the safety impact and better serve
patients. Further, FXR314 combination therapy could enable the
successful achievement of clinical remission in a greater
percentage of patients.
In both Organovo’s proprietary 3D human models
and in preclinical animal models of disease, FXR314 treatment
demonstrates a reduction in the disruption of the intestinal
lining, which protects against bacteria penetrating into the
intestinal wall. Further, our models and published literature1
indicate a role of FXR314 in modulating responses in innate
lymphoid cells (ILCs) in the intestine, preventing the cytokine
release that triggers a systemic immune-inflammatory response. In
so doing, FXR314 can complement the typical drug therapies used in
IBD, which themselves inhibit the activity of the cytokines driving
the systemic response. Since FXR314 has a target that is upstream
of most currently prescribed drugs, it can potentially strongly
complement the use of these drugs when used in combination.
Organovo has previously announced plans for a
Phase 2a study of FXR314 in ulcerative colitis, with a readout
expected in 1H 2025. In addition, the company will now begin
preclinical studies with combination therapies using FXR314 and
currently approved therapies or equivalent that can benefit from
lower dosing. Further, over time the company expects to share data
generated in its proprietary 3D human models of inflammatory bowel
disease that further demonstrate the potential for combination
effects.
“We remain excited about the potential of FXR314
to treat IBD due to its unique mechanism of action, and about our
upcoming Phase 2 study to demonstrate its activity in ulcerative
colitis,” said Keith Murphy, Organovo Executive Chairman. “As we
enroll patients and complete the Phase 2, we are eager to explore
the drug’s potential for combination therapy and share our findings
and the opportunities we see to further benefit patients, some of
whom don’t benefit from existing therapies due to safety
limitations or low response rates. There remains great unmet need
in inflammatory bowel disease, and we look forward to defining
multiple roles FXR314 can play in providing treatment
solutions.”
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 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 August
10, 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.
Investor Contact
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Counseladmin@amatoandpartners.com
1 Fu T, Li Y, Oh TG, Cayabyab F, He N, Tang Q,
Coulter S, Truitt M, Medina P, He M, Yu RT, Atkins A, Zheng Y,
Liddle C, Downes M, Evans RM. FXR mediates ILC-intrinsic responses
to intestinal inflammation. Proc Natl Acad Sci U S A. 2022 Dec
20;119(51):e2213041119. doi: 10.1073/pnas.2213041119. Epub 2022 Dec
12. PMID: 36508655; PMCID: PMC9907109.
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