Akero Therapeutics Presents Analyses of Phase 2b HARMONY Study at the 2023 International Liver Congress Reinforcing and Characterizing EFX-Related Improvements in Liver Histopathology
23 Junho 2023 - 8:00AM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company
developing transformational treatments for patients with serious
metabolic disease marked by high unmet medical need, today
announced two presentations of secondary and post-hoc analyses of
the Phase 2b HARMONY study of efruxifermin (EFX) in patients with
pre-cirrhotic nonalcoholic steatohepatitis (NASH), fibrosis stage 2
or 3 (F2-F3). The posters are being presented at the 2023
International Liver Congress today and tomorrow and will be
available on Akero’s website.
“We continue to be really pleased with the consistency of
clinical response associated with EFX treatment across four
independently conducted Phase 2 studies,” said Tim Rolph, chief
scientific officer of Akero. “The new analyses not only expand on
previously reported results, but also indicate non-invasive testing
could be used to monitor clinical response to EFX in a real-world
setting where liver biopsies are a barrier to diagnosis of NASH and
assessment of treatment-related effects.”
“Noninvasive tests of liver injury, inflammation and
fibrosis are improved by efruxifermin and correlate with
histological improvements in patients with F2-F3 NASH: secondary
analysis of Ph2b HARMONY study” (Poster TOP-091, Abstract
1669) was selected as a Top Poster (“among the best in its
category”) and is being displayed in a dedicated area of the
Congress.
- Results of non-invasive tests performed as part of the HARMONY
study were correlated with EFX-related changes in liver
histopathology after 24 weeks of treatment.
- The poster shows that EFX-associated changes in non-invasive
tests were associated with improvements in NASH histopathology.
Normalization of liver fat content and markers of liver injury, AST
or ALT, was associated with higher probability of resolving
histopathologic features of steatohepatitis and fibrosis after 24
weeks of treatment with EFX.
- These results indicate non-invasive tests could be used to
monitor and predict responses to treatment with EFX among patients
with F2-F3 fibrosis and NASH.
“Characterization of the Patterns of Resolution of
Histopathology After Efruxifermin Treatment of Patients with NASH
Fibrosis (F2/3) for 24 Weeks” (Poster FRI-512, Abstract
#2440) was selected for presentation during the poster tour. It
will be summarized by Akero’s vice president of clinical research
and medical affairs, Reshma Shringarpure, between 15.30-16.15 CET
as part of the Metabolism, Alcohol and Toxicity track hub on June
24th.
- The post-hoc semi-quantitative analysis characterized changes
in liver histopathology through the evaluation of
steatosis-activity-fibrosis (SAF) and SAF-Activity (SAF-A)
scores.
- Improvements in SAF and SAF-A scores following treatment with
EFX corroborated the already reported improvement in NASH-CRN
fibrosis stage and substantial resolution of steatohepatitis.
- Post-hoc qualitative analyses investigated histological
features associated with fibrosis regression by comparing
post-treatment with pre-treatment biopsies.
- The comparison revealed intra-grade and intra-stage
improvements which were not detected by categorical staging as a
scoring system for histologic features of regression.
- These orthogonal post-hoc analyses provided evidence of a
progressive dose-dependent response to EFX.
About NASHNASH is a serious form of NAFLD
(non-alcoholic fatty liver disease) that is estimated to affect 17
million Americans. NASH is characterized by an excessive
accumulation of fat in the liver that causes stress and injury to
liver cells, leading to inflammation and fibrosis, which can
progress to cirrhosis, liver failure, cancer and eventually death.
There are no approved treatments for the condition and NASH is the
fastest growing cause of liver transplants and liver cancer in the
US and Europe.
About EfruxiferminEfruxifermin (EFX), formerly
known as AKR-001, is Akero’s lead product candidate for NASH,
currently being evaluated in the ongoing Phase 2b HARMONY and
SYMMETRY studies. EFX is designed to reduce liver fat and
inflammation, reverse fibrosis, increase insulin sensitivity and
improve lipids. This holistic approach offers the potential to
address the complex, multi-system disease state of NASH, including
improvements in lipoprotein risk factors linked to cardiovascular
disease – the leading cause of death in NASH
patients. Engineered to mimic the biological activity profile
of native FGF21, EFX is designed to offer convenient once-weekly
dosing and has been generally well-tolerated in clinical trials to
date.
About Akero TherapeuticsAkero Therapeutics
is a clinical-stage company developing transformational treatments
for patients with serious metabolic diseases marked by high unmet
medical need, including NASH, a disease without any approved
therapies. Akero's lead product candidate, EFX, is a differentiated
Fc-FGF21 fusion protein that has been engineered to mimic the
balanced biological activity profile of native FGF21, an endogenous
hormone that alleviates cellular stress and regulates metabolism
throughout the body. EFX is designed to offer convenient
once-weekly subcutaneous dosing. The consistency and magnitude of
observed effects position EFX to be a potentially best-in-class
medicine, if approved, for treatment of NASH. EFX is currently
being evaluated in two Phase 2b clinical trials: the HARMONY study
in patients with pre-cirrhotic NASH (F2-F3 fibrosis), and the
SYMMETRY study in patients with cirrhotic NASH (F4 fibrosis,
compensated). EFX has also been evaluated in an expansion cohort of
the SYMMETRY study, Cohort D, comparing the safety and tolerability
of EFX to placebo when added to an existing GLP-1 receptor agonist
in patients with pre-cirrhotic NASH (F1-F3 fibrosis) and Type 2
diabetes, for which topline results were reported on June 5, 2023.
Akero is headquartered in South San Francisco. Visit us at
akerotx.com and follow us on LinkedIn and Twitter for more
information.
Forward Looking Statements Statements contained
in this press release regarding matters that are not historical
facts are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements, including, but not limited to,
statements regarding Akero’s business plans and objectives,
including future plans or expectations for EFX, the therapeutic
effects of EFX, as well as the dosing, safety and tolerability of
EFX, including in combination with GLP-1 therapies; and upcoming
milestones, including the results, and expected timing to report
such results of Akero’s Phase 2b SYMMETRY study. Any
forward-looking statements in this press release are based on
management's current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the success, cost, and timing of Akero’s
product candidate development activities and planned clinical
trials; Akero’s ability to execute on its strategy; positive
results from a clinical study, including Cohort D, may not
necessarily be predictive of the results of future or ongoing
clinical studies; regulatory developments in the United States and
foreign countries; Akero’s ability to fund operations; as well as
those risks and uncertainties set forth more fully under the
caption "Risk Factors" in Akero’s most recent Annual Report on Form
10-K and Quarterly Report on Form 10-Q, as filed with the
Securities and Exchange Commission (SEC) as well as discussions of
potential risks, uncertainties and other important factors in
Akero’s other filings and reports with the SEC. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Akero undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
Investor Contact:Christina
Tartaglia212.362.1200IR@akerotx.com
Media Contact:Sarah
O’Connell732.456.0092soconnell@vergescientific.com
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