Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage
biotechnology company developing transformational treatments for
patients with serious metabolic disorders marked by high unmet
medical need, today announced two presentations featuring its lead
product candidate efruxifermin (EFX) at the European Association
for the Study of the Liver (EASL) Congress 2024, in Milan, Italy.
The presentations will also be available on Akero’s website
following the meeting.
A late-breaking oral presentation will feature 96-week data from
HARMONY, a Phase 2b study evaluating the efficacy and safety of EFX
in patients with metabolic dysfunction-associated steatohepatitis
(MASH), fibrosis stage 2 or 3 (F2–F3). The study met its primary
endpoint of ≥1-stage improvement in fibrosis with no worsening of
MASH after 24 weeks of treatment for both the 50 mg EFX (41%,
p<0.05) and 28 mg EFX (39%, p<0.05) dose groups, compared to
20% for the placebo group. At Week 96, response rates for this
endpoint increased to 75% (p<0.001) for 50 mg EFX and 46%
(p=0.07) for 28 mg EFX, vs 24% for placebo.
The study also met additional histology endpoints at week 96.
Notably 36% (p<0.01) and 31% (p<0.01) of patients treated
with 50 mg EFX and 28 mg EFX, respectively, had a 2-stage
improvement in fibrosis without worsening of MASH, more than
10-fold the placebo rate of 3%.
A comparison of week 96 with week 24 results showed that
treatment response among EFX-treated patients was both sustained
and expanded with longer treatment, particularly among the 50 mg
EFX group. More than 80% of all EFX-treated patients with improved
fibrosis at week 24 experienced sustained improvement through week
96, reflecting maintained reductions in markers of liver injury and
fibrosis, whereas more than half of placebo responders at week 24
failed to maintain their response. In addition, 63% of patients
treated with EFX 50 mg who were non-responders at week 24
experienced an improvement in fibrosis and no worsening of MASH
with the benefit of treatment for 96 weeks, three times the placebo
rate of 21%. In a subset of patients with baseline F3, treatment
with EFX was associated with response on fibrosis improvement
similar to the overall study population of F2 and F3 patients
treated with EFX, showing the potential for treating more-advanced
fibrosis, associated with increased risk of progression to
cirrhosis. Results from the HARMONY study indicate EFX was
generally well tolerated, with no liver injury or decompensation
events, and no deaths. The most frequent adverse events (AEs) were
transient Grade 1 or 2 gastrointestinal events, with an overall
event profile similar to what was observed during the first 24
weeks.
A poster presentation will present results from a post-hoc
analysis of key biomarkers associated with collagen synthesis and
degradation. These data improve our understanding of EFX
pharmacology and its effects on extracellular matrix (ECM)
remodeling in the liver and fibrosis improvement. EFX treatment was
associated with significant changes in the ECM toward a potentially
beneficial phenotype, with decreased interstitial collagens
(fibrils) and regeneration of structural collagens (basement
membrane). The observed remodeling of ECM biomarkers after 24 weeks
was associated with reductions in markers of liver injury over the
same period and with improvements in liver fibrosis after longer
treatment.
Together, the data to be presented at EASL suggest that EFX
modulates markers of pathological fibrosis consistent with
improvements in metabolic health, liver health, and suppression of
fibrogenesis.
“We’re looking forward to sharing our Week 96 data from the
Phase 2b HARMONY study in patients with pre-cirrhotic MASH (F2–F3)
with the scientific community at EASL Congress,” said Andrew Cheng,
M.D., Ph.D., president and chief executive officer of Akero. “We
are highly encouraged by these results, which are the first reports
of histological improvement after more than 48 weeks. We believe
the unprecedented response rates of EFX-treated patients who
experienced not only 1-, but 2-stage improvement in fibrosis
without worsening of MASH observed in the HARMONY study, sustained
over 96 weeks, is a key differentiator of EFX from other treatments
in the MASH therapeutic landscape.”
Details of the presentations are as follows:
Oral Presentation Title: Efruxifermin
significantly reduced liver fibrosis in MASH patients with F2–F3
fibrosis, with sustained improvement in liver injury and resolution
of steatohepatitis over 96 weeks (HARMONY phase 2b study)
- Presenter: Vlad Ratziu, M.D., Ph.D.
Professor of Hepatology, Sorbonne Université and the Hôpital
Pitié-Salpêtrière Medical School
- Late Breaker Abstract
Number: LBO-002
- Session Title: Late Breaker
- Session Date and Time: Saturday, June 8,
2024, 2:00 PM – 3:30 PM CEST
- Presentation Time: 2:15 PM CEST
- Location: Gold Room
Poster Presentation Title: Efruxifermin
treatment improved collagen biomarkers consistent with remodeling
of the extracellular matrix in patients with F2-F3 fibrosis due to
MASH
- Presenter: Erik Tillman, Ph.D., Associate
Director, Translational Biology & Pharmacology
- Late Breaker Abstract
Number: SAT-220-YI
- Session Title: MASLD: Therapy
- Session Date and Time: Saturday, June 8,
8:30 AM – 5:00 PM CEST
- Location: Poster Area
About the HARMONY Study The Phase 2b HARMONY
study was a multicenter, randomized, double-blind,
placebo-controlled trial in biopsy-confirmed adult MASH patients
with fibrosis stage 2 or 3. The study enrolled a total of 128
patients who were randomized to receive once-weekly subcutaneous
dosing of 28 mg or 50 mg EFX, or placebo for 24 weeks, 126 of whom
received at least one study dose. The primary efficacy endpoint for
the study was the proportion of subjects who experienced ≥1-stage
fibrosis improvement without worsening of MASH. The study continued
for up to 96 weeks. Secondary endpoints at Week 96 included
proportion of patients with ≥1-stage fibrosis improvement and no
worsening of MASH, proportion of patients with 2-stage fibrosis
improvement without worsening of MASH, and proportion of patients
with ≥1-stage fibrosis improvement and MASH resolution, as well as
changes from baseline in noninvasive markers of liver injury and
fibrosis, glycemic control, lipoproteins, and change in body weight
as well as safety and tolerability measures.
About EfruxiferminEfruxifermin (EFX), Akero’s
lead product candidate for MASH, is a long-acting, bivalent
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 appears to reduce liver fat and
inflammation, reverse fibrosis, increase insulin sensitivity and
improve lipid and lipoprotein profile. This pleiotropic mechanism
offers the potential to address the complex, multi-system disease
state of MASH, including improvements in risk factors linked to
cardiovascular disease – the leading cause of death in patients
with pre-cirrhotic MASH. EFX is designed to offer convenient
once-weekly dosing and has been generally well tolerated in
clinical trials to date.
About MASHMASH is a serious form of metabolic
dysfunction-associated steatotic liver disease (MASLD) that is
estimated to affect more than 17 million Americans. MASH 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. MASH is the fastest-growing cause of
liver transplants and liver cancer in the US and Europe.
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 MASH. Akero's lead product candidate, EFX,
is currently being evaluated in the ongoing SYMMETRY study, a
96-week Phase 2b clinical trial in patients with compensated
cirrhosis due to MASH (F4 fibrosis), as well as two ongoing Phase 3
clinical trials: the SYNCHRONY Histology study in patients with
pre-cirrhotic MASH (F2-F3 fibrosis) and the SYNCHRONY Real-World
study in patients with MASH (F1-F3 fibrosis) or MASLD. A third
clinical trial, the SYNCHRONY Outcomes study in patients with
compensated cirrhosis due to MASH (F4 fibrosis), is expected to be
initiated in the second quarter of 2024. The Phase 3 SYNCHRONY
program builds on the results of two Phase 2b clinical trials, the
HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the
SYMMETRY study in patients with compensated cirrhosis due to MASH
(F4). 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; the timing and initiation of Akero’s
Phase 3 SYNCHRONY program and upcoming milestones. 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 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:Peg
Rusconi617.910.6217peg.rusconi@vergescientific.com
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