Akero Presents New Analysis of Phase 2a BALANCED Study Data Showing Additional Qualitative Evidence of Histological Improvement in EFX-treated NASH Patients after 16 Weeks of Treatment
13 November 2021 - 12:01AM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic
biotechnology company developing transformational treatments for
patients with serious metabolic diseases marked by high unmet
medical need, today announced a new, blinded, post-hoc analysis of
its Phase 2a BALANCED study of efruxifermin (EFX) in
biopsy-confirmed patients with non-alcoholic steatohepatitis
(NASH), which will be presented in a poster at The Liver Meeting of
the American Association for the Study of Liver Diseases (AASLD),
Nov. 12-15, 2021.
The analysis, entitled “Characterization of Histologic Patterns
of Improvement Following Treatment With Efruxifermin (EFX) in NASH
Patients With Fibrosis,” evaluated pre- and post-treatment biopsies
in 40 EFX-treated patients from the BALANCED study. These
post-treatment biopsies showed improvements in histological
features of steatohepatitis in 87% (35 of 40) and fibrosis in 80%
(32 of 40) of EFX-treated patients after 16 weeks of treatment.
Patterns of disease regression were evident in many patients who
did not meet the categorical thresholds for either NASH resolution
without worsening of fibrosis or at least a one-stage improvement
in fibrosis without worsening of NASH. For example, some patients
achieved resolution of hepatocyte ballooning without complete
resolution of NASH, and some patients with bridging fibrosis (F3)
showed evidence of features of fibrosis regression (e.g.
interrupted septa) without complete reversion to a lower,
non-bridging stage. These and other qualitative improvements, which
are consistent with previously reported reductions in categorical
scores, provide further evidence of the potential rapidity of EFX’s
disease modifying activity.
“More than 80% of biopsied patients treated with EFX showed
signs of histological improvements after only 16 weeks of treatment
with EFX. The observed trends highlight the potential to achieve
higher response rates after longer periods of treatment, based on
the categorical endpoints accepted for use in Phase 3 trials,” said
Kitty Yale, chief development officer of Akero. “We are eager to
see the histology results after treatment for 24 weeks or more in
the ongoing Phase 2b studies with EFX.”
The BALANCED study was a randomized, placebo-controlled Phase 2a
trial that enrolled 80 biopsy-confirmed, pre-cirrhotic NASH
patients (F1 to F3 fibrosis stage) who received either placebo or
EFX for 16 weeks as a weekly subcutaneous injection in one of three
doses: 28 mg, 50 mg, or 70 mg. Of the 40 EFX-treated patients who
received end-of-treatment biopsies, 48% achieved a one-stage
improvement in fibrosis without worsening of NASH, and 48% achieved
NASH resolution without worsening of fibrosis. These two endpoints
remain the FDA-recommended endpoints for Phase 3 clinical trials in
pre-cirrhotic NASH patients.
The analysis presented at AASLD was proposed by Cynthia A.
Behling, M.D., Ph.D., a liver pathologist at Pacific Rim Pathology
Medical Group in San Diego who was the central reader for the
BALANCED study, based on her assessments of biopsies concurrent
with categorical scoring and blinded to both treatment arm and
biopsy sequence. The analysis provides a more detailed view of
histological change than is reflected in the categorical,
FDA-recommended scoring for NASH resolution and fibrosis stage.
Moreover, two target populations at elevated risk of NASH
progression—carriers of the PNPLA3 risk allele (I148M) and/or those
with Type 2 diabetes—showed comparable qualitative and/or
quantitative histological improvements to the rest of the patients
in the BALANCED study.
“This qualitative analysis gives us even greater confidence in
the emerging evidence of EFX’s anti-fibrotic effects and the
potential for a strong performance in reaching phase 3 study
endpoints with longer treatment periods,” said Andrew Cheng, M.D.,
Ph.D., president and chief executive officer of Akero. “Taken
together, this and other analyses of our data provide compelling
evidence that EFX has the potential to treat many of the complex
causes of NASH, as well as to treat patients at greatest risk of
progression to later stages of NASH-associated fibrosis and
cirrhosis.”
About Akero Therapeutics
Akero Therapeutics is a clinical-stage cardio-metabolic company
developing transformational treatments for non-alcoholic
steatohepatitis (NASH), a disease without any approved therapies.
Akero's lead product candidate, efruxifermin (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 F2/F3 advanced fibrosis and the SYMMETRY study in
compensated cirrhotic (F4) patients. Akero is headquartered in
South San Francisco. Visit us at www.akerotx.com 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,
upcoming milestones, and therapeutic effects of EFX, as well as the
dosing, safety and tolerability of EFX; Akero’s Phase 2a
BALANCED study, including results and post-hoc analysis of its
data; and the potential impact of COVID-19 on strategy, future
operations, enrollment and clinical trials. 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: risks related to
the impact of COVID-19 on Akero’s ongoing and future operations,
including potential negative impacts on Akero’s employees,
third-parties, manufacturers, supply chain and production as well
as on global economies and financial markets; 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 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, as filed with the Securities and Exchange Commission (SEC)
and quarterly reports on Form 10-Q filed with the 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 TartagliaStern
Investor Relations,
Inc.212.362.1200christina.tartaglia@sternir.com
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