Organovo Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Showing Both Reduction in Liver Fat Content and Strong Safety and Tolerability Compared to Placebo
15 Aprile 2024 - 2:05PM
Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage
biotechnology company focused on developing novel treatment
approaches based on demonstration of clinical promise in
three-dimensional (3D) human tissues, today released the complete
details of its 16-week, randomized, placebo-controlled,
multi-center Phase 2 study of the non-steroidal, non-bile acid FXR
agonist FXR314 for the treatment of metabolic function-associated
steatohepatitis (MASH). Study results demonstrated statistically
significant reduction in liver fat content from baseline in
patients receiving FXR314 compared to placebo.
Study subjects receiving FXR314 achieved
statistically significant reduction in liver fat content from
baseline, with LS mean percent reduction at end of treatment of
22.8% (p=0.0010) with 3 mg and 17.5% (p=0.0267) with 6 mg doses of
FXR314 compared to 6.1% in the placebo group. The proportion of
subjects with >30% magnetic resonance imaging-derived proton
density fat fraction (MRI-PDFF) reduction was 29.2% (p=0.0023) and
32.2% (p=0.0020) for 3 mg and 6 mg FXR314, respectively, compared
to 9.5% with placebo. Investigators observed improvements in
hepatocellular damage and liver function based on serological
measures, with no evidence of worsening of liver fibrosis.
|
FXR314 3 mg |
FXR314 6 mg |
Placebo |
Liver fat reduction(LS mean reduction from baseline, SE) |
22.8 + 3.6%p=0.0010 |
17.5 + 3.7%p=0.0267 |
6.1 + 3.5% |
Subjects with >30% MRI-PDFF reduction |
29.2%p=0.0023 |
32.2%p=0.0020 |
9.5% |
Pruritus |
2.8% |
4.2% |
2.8% |
Pruritus-related treatment discontinuation |
0% |
0% |
0% |
FXR314 was also found to be safe and well
tolerated. Treatment-emergent adverse events were mostly mild to
moderate in severity, with incidence comparable between FXR314 3
mg, 6 mg, and placebo. Drug-related treatment discontinuation was
minimal and similar across groups. There was also no evidence with
FXR314 of adverse events considered common in the FXR class,
including measures of pruritus (3 mg 2.8%, 6 mg 4.2% and placebo
2.8%) and LDL-C levels (change from baseline of 1.5%, 4.5% and
-3.6% for 3mg, 6mg, and placebo groups respectively).
“The key findings of this study are that once
daily oral FXR314 demonstrated statistically significant liver fat
reduction and excellent tolerability. Whereas other FXR
agonists have had challenges in providing clear benefit without
significant pruritus or other adverse events, or have had lack of
efficacy potentially related to lack of sustained exposure, we are
pleased to note FXR314’s data demonstrate it clearly rises above
previous problems seen with the class,” stated Keith Murphy,
Organovo’s Executive Chairman. “Given these exciting findings, we
believe the data are supportive of further clinical development of
FXR314 in MASH.”
The clinical trial evaluated the safety,
tolerability, and pharmacological activity of FXR314, as measured
by reductions in liver fat content with magnetic resonance
imaging-derived proton density fat fraction (MRI-PDFF), changes in
liver enzymes, low-density lipoprotein cholesterol (LDL-C) levels,
and incidence of pruritus. The treatment population were MASH
patients diagnosed via biopsy, magnetic resonance elastography
(MRE), or transient elastography (TE FibroScan), and who had liver
fat content ≥ 10% as measured by MRI-PDFF. A total of
214 patients were randomized in a 1:1:1 ratio to either 3 mg or 6
mg of FXR314, or placebo. Treatment was administered orally once
daily for 16 weeks. The Company expects that detailed findings of
this study (Clinical trial registry NCT047773964) will be presented
at an upcoming conference.
About OrganovoOrganovo 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 applications 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 StatementsAny
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.
ContactCORE IRpr@coreir.com
Source: Organovo, Inc.
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