Organovo Announces FXR Program
21 Mars 2023 - 1:05PM
Organovo Holdings, Inc. (NASDAQ: ONVO), a clinical stage
biotechnology company that is focused on developing novel human
therapies with demonstrated function in high fidelity
three-dimensional (3D) tissues that recapitulate key aspects of
human disease, today announced a clinical program for FXR 314, an
FXR agonist that has completed initial clinical trials. FXR314 is a
drug with safety and tolerability after daily oral dosing in Phase
1 and Phase 2 trials. Further, FXR314 has FDA clinical trial
authorization for a Phase 2 trial in ulcerative colitis.
“We believe FXR314 to be a best-in-class FXR
agonist with high potency and the potential to avoid dose-limiting
toxicity issues found in other FXR-directed compounds,” said Keith
Murphy, Organovo’s Founder and Executive Chairman. “Our 3D human
tissue models will allow us to find the most effective clinical and
commercial development strategy for this drug in inflammatory bowel
disease patients, and we expect FXRs to have a widening set of
therapeutic applications over time.”
Organovo’s FXR program announcement updates its
previous guidance that it would first begin Phase 1 trials in 2025.
The Company plans to give guidance on Phase 2 timelines after an
internal determination of the best path forward. The Company
continues to expect to file INDs starting in 2025 from fully
internally developed molecules and expects to issue additional
guidance on clinical plans in the coming months.
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 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 June 10, 2022, as such risk factors are
updated in its most recently filed Quarterly Report on Form 10-Q
filed with the SEC on February 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.
Investor Contact
Amato and Partners, LLCInvestor Relations
Counseladmin@amatoandpartners.com
Organovo (NASDAQ:ONVO)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Organovo (NASDAQ:ONVO)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024