Akero Therapeutics Announces Publication of the Harmony Phase 2b Trial Results in The Lancet Gastroenterology & Hepatology
04 Octubre 2023 - 7:00AM
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 publication in The Lancet Gastroenterology &
Hepatology of results from the HARMONY Phase 2b trial in
nonalcoholic steatohepatitis (NASH).
The paper, available online, provides data on the safety,
tolerability, and efficacy of once-weekly subcutaneous injections
of efruxifermin (EFX) (28mg or 50mg) compared to placebo in
patients with pre-cirrhotic NASH, fibrosis stage 2 or 3 (F2-F3).
Results showed that both EFX doses achieved statistical
significance on primary and secondary histopathology endpoints
after 24 weeks. Treatment with EFX was generally well-tolerated,
with a tolerability profile comparable to that observed in Akero’s
Phase 2a BALANCED study. Study participants in HARMONY exhibited
characteristics associated with high risk of progressive NASH,
presenting with obesity, type 2 diabetes, and stage 2 or 3
fibrosis. In this context, both doses of EFX demonstrated
statistically significant and broadly-based effects on multiple
secondary endpoints, including improvements in non-invasive markers
of liver injury and fibrosis, liver fat content, glycemic control,
lipoproteins, and body weight.
“Publication of the HARMONY Phase 2b trial results is an
important milestone in our ongoing evaluation of EFX,” said Kitty
Yale, chief development officer of Akero. “This comprehensive data
set and analysis provide a deeper understanding of the therapeutic
effects of EFX. We look forward to initiating our Phase 3 SYNCHRONY
program, and to continue working toward bringing meaningful
therapies to patients living with NASH.”
This month, Akero plans to report topline week 36 results from a
second Phase 2b study, SYMMETRY, evaluating treatment of patients
with compensated cirrhosis due to NASH. The Phase 3 SYNCHRONY
program is on track to begin enrolling by the end of this year.
SYNCHRONY Histology will evaluate the efficacy of 28mg and 50mg
doses of EFX in patients with biopsy confirmed pre-cirrhotic NASH,
fibrosis stage 2 or 3 (F2-F3). SYNCHRONY Real-World will assess
safety and tolerability of EFX in patients with non-invasively
diagnosed NASH or NAFLD.
About the HARMONY StudyThe ongoing Phase 2b
HARMONY study is a multicenter, randomized, double-blind,
placebo-controlled, dose-ranging trial in biopsy-confirmed adult
NASH patients with fibrosis stage 2 or 3. The study enrolled 128
patients who received once-weekly subcutaneous dosing of 28mg or
50mg EFX, or placebo for 24-weeks. The primary efficacy endpoint
for the study was the proportion of subjects who achieved at least
a one-stage improvement in fibrosis without worsening of NASH at
week 24. Secondary measures included NASH resolution, change from
baseline in liver fat, liver enzymes, noninvasive markers of liver
fibrosis, glycemic control, lipoproteins, and body weight at 24
weeks as well as safety and tolerability measures. Participants are
continuing to be treated in their randomly assigned groups for 96
weeks to evaluate safety and tolerability during long-term dosing,
as well as durability of histological response.
About NASHNASH is a serious form of
non-alcoholic fatty liver disease (NAFLD) 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) 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. 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). Akero is
headquartered in South San Francisco. Visit us at 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 EFX, the therapeutic
effects of EFX, as well as the dosing, safety and tolerability of
EFX; the timing and completion of enrollment of our Phase 3
SYNCHRONY program by end of this year; and upcoming milestones,
including the results, and expected timing to report the topline
week 36 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 any of its clinical studies 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:Austin
Murtagh212.698.8696IR@akerotx.com
Media Contact:Sarah
O’Connell732.456.0092soconnell@vergescientific.com
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