Akero Therapeutics Announces Positive End-of-Phase 2 Meeting with the FDA and SYNCHRONY Phase 3 Program for Efruxifermin in NASH
March 29 2023 - 4:01PM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company
developing transformational treatments for patients with serious
metabolic disease and high unmet medical need, today announced a
positive End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) as well as details of the anticipated
SYNCHRONY Phase 3 efruxifermin program for the treatment of
nonalcoholic steatohepatitis (NASH). There are currently no
approved therapies for the treatment of NASH, a serious form of
liver disease estimated to affect more than 17 million Americans.
“We are appreciative of the FDA’s support and guidance and are
pleased to have aligned on key features of our SYNCHRONY Phase 3
program, with further dialogue envisaged following readout of the
Phase 2b SYMMETRY trial evaluating EFX in patients with cirrhosis
due to NASH,” said Kitty Yale, chief development officer of Akero.
“The strength of EFX’s clinical profile reported to date in our
Phase 2 studies gives us confidence in EFX’s potential to be a
best-in-class FGF21 analog for treating NASH, if approved, and we
look forward to enrolling patients into our first two Phase 3
trials within the SYNCHRONY program later this year.”
Based on ongoing discussions with the FDA, the SYNCHRONY Phase 3
program will start enrolling patients into two parallel,
randomized, placebo-controlled clinical trials during the second
half of this year.
- SYNCHRONY
Histology will evaluate the efficacy of 28mg and
50mg doses of EFX in patients with biopsy confirmed pre-cirrhotic
NASH, with fibrosis stage 2 or 3 (F2-F3). The primary endpoint will
be ≥ 1-stage fibrosis improvement AND resolution of NASH.
- SYNCHRONY
Real-World will assess safety and tolerability of
EFX in patients with non-invasively diagnosed NASH or NAFLD. Key
secondary endpoints are to include change in biomarkers of fibrosis
and other established non-invasive endpoints.
- The duration of
and total number of subjects to be enrolled in the SYNCHRONY
Histology and Real-World trials
are subject to confirmation with the FDA.
Following readout of the Phase 2b SYMMETRY trial during the
fourth quarter of this year, and subsequent interactions with the
FDA, Akero expects to finalize the design of the third Phase 3
clinical trial within the SYNCHRONY program.
- SYNCHRONY
Outcomes is planned to evaluate the efficacy and
safety of EFX in a compensated cirrhotic population, for which the
primary endpoint will be clinical outcomes.
As previously indicated and consistent with ICH guidelines, the
overall SYNCHRONY program has been designed to comprise a minimum
of 1,500 patients exposed to the dose(s) of EFX that are
anticipated to be proposed for approval.
About NASHNon-alcoholic steatohepatitis (NASH)
is a serious, life-threatening disease that has rapidly emerged as
a leading cause of liver failure in the world and is the leading
indication for liver transplant among women. An estimated 17.3
million Americans had NASH (fibrosis stages 1-4) in 2016, a number
that is predicted to increase to 27.0 million by 2030. NASH is a
severe form of nonalcoholic fatty liver disease (NAFLD)
characterized by hepatocyte injury, liver inflammation, and
fibrosis that can progress to scarring (cirrhosis), liver failure,
cancer and death. There are currently no approved therapies for the
disease.
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 trials, as described in the “About Akero Therapeutics”
section below. EFX is designed to reverse fibrosis, reduce liver
fat and inflammation, increase insulin sensitivity, and improve
lipoproteins. 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 non-alcoholic steatohepatitis (NASH), a
disease without any approved therapies. Akero's lead product
candidate, efruxifermin (EFX), is a differentiated 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 is designed to offer convenient
once-weekly subcutaneous dosing. The consistency and magnitude of
observed effects to date 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 trial in patients with pre-cirrhotic NASH (F2-F3 fibrosis),
and the SYMMETRY trial in patients with cirrhotic NASH (F4
fibrosis, compensated). EFX is also being evaluated in an expansion
cohort of the SYMMETRY trial, comparing 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. Akero is headquartered in South San Francisco. Visit
akerotx.com and follow us on LinkedIn and Twitter for more
information.
Forward-Looking StatementsStatements 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 efruxifermin (EFX), the
therapeutic effects of EFX, as well as the dosing, safety and
tolerability of EFX; the SYNCHRONY Phase 3 program, including the
design of trials and expected timing thereof; and expected timing
to report 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: 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 and subsequent filings 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:Austin
Murtagh212.698.8696IR@akerotx.com
Media Contact:Sarah
O’Connell732.456.0092soconnell@vergescientific.com
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