Organovo Presents Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver Meeting
20 November 2024 - 2:05PM
Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage
biotechnology company focused on developing novel treatment
approaches in inflammatory bowel disease (IBD) including ulcerative
colitis, today announces that its oral presentation of its lead
clinical stage drug FXR314 by Dr. Eric Lawitz of the Texas Liver
Institute and the University of Texas Health San Antonio was
featured at The Liver Meeting, sponsored by the American
Association for the Study of Liver Diseases (AASLD). The meeting
was held November 15-19, 2024 in San Diego, California.
The presentation entitled “Pharmacokinetics,
Safety and Efficacy of the Novel Non-bile Acid FXR Agonist FXR314
in Patients with Metabolic Dysfunction-Associated Steatohepatitis:
Results from a Phase 2 Study” was presented on Sunday, November 17
in the MASLD and MASH – New therapies session.
Dr. Lawitz shared the complete details of the
16-week, randomized, placebo-controlled, multi-center Phase 2 study
of FXR314 in MASH patients. A total of 214 patients were randomized
in a 1:1:1 ratio to either 3 mg or 6 mg of FXR314, or placebo.
Study results demonstrated statistically significant reduction in
liver fat content from baseline in patients receiving FXR314
compared to placebo, and a safety profile demonstrating
significantly lower pruritus rates than seen with other FXR
agonists.
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 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
low in frequency and similar across groups. FXR314 did not
demonstrate significant adverse events typical of the FXR class,
including 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).
|
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% |
“These results are encouraging as we saw FXR314
treatment resulting in liver fat reduction but did not demonstrate
the expected toxicities of this class,” stated Dr. Lawitz. “Due to
this unique profile, I am excited about the prospects of further
evaluating FXR314 for the treatment of MASH. The intestinal
activating specificity is intriguing.”
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 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 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 May 31, 2024, as such risk factors
are updated in its most recently filed Quarterly Report on Form
10-Q filed with the SEC on November 8, 2024 and the
Registration Statement on Form S-1 (File No. 333-282841). 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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