Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Cohort D Study in Clinical Gastroenterology and Hepatology
08 March 2024 - 8:01AM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company
developing transformational treatments for patients with serious
metabolic disease, today announced publication of results in
Clinical Gastroenterology and Hepatology from an expansion cohort
(Cohort D, N=31) of the Phase 2b SYMMETRY study.
The publication, available online, reports results of the
12-week study to assess safety and tolerability of efruxifermin
(EFX) compared to placebo when added to a stable dose of GLP-1
receptor agonist (GLP-1RA) in patients with Type 2 diabetes (T2D)
and F1-F3 liver fibrosis due to metabolic dysfunction-associated
steatohepatitis (MASH), formerly known as NASH.
Tolerability of EFX on top of GLP-1RA (N=21 patients) was
generally comparable to GLP-1RA alone (placebo, N=10). The most
frequent adverse events for EFX-treated patients were grade 1 or 2
gastrointestinal events (diarrhea, nausea, and increased appetite).
One patient treated with EFX discontinued due to nausea and one
EFX-treated patient withdrew consent prior to Week 12. There were
no drug-related serious adverse events. The overall tolerability
profile was similar to that observed in Akero’s prior BALANCED and
HARMONY studies in patients with MASH (F1-F3). Patients treated
with EFX plus GLP-1RA showed a similar mean weight loss from
baseline relative to patients treated with GLP-1RA alone.
Non-invasive markers of liver health showed clinically
meaningful improvements following treatment for 12 weeks with EFX
plus GLP-1RA compared to GLP-1RA alone (placebo). Notably, liver
fat was reduced from baseline by 65% for EFX on top of GLP-1RA
compared to a 10% relative reduction for GLP-1RA alone, with levels
normalized (5% absolute) in almost 90% of patients receiving EFX
plus GLP-1RA compared to 10% of those receiving GLP-1RA alone. In
addition, patients treated with EFX plus GLP-1RA (N=21) had greater
improvements in non-invasive markers of liver injury (ALT and AST)
and fibrosis (Pro-C3 and ELF), than those receiving GLP-1RA alone
(N=10). Markers of glycemic control and lipid metabolism were also
improved more with EFX plus GLP-1RA than GLP-1RA alone, reflecting
the complementary insulin-sensitizing action of EFX when combined
with an insulin secretagogue such as GLP-1RA.
“We believe these data indicate that EFX could be an important
treatment option for patients with MASH who are already receiving
GLP-1RA for T2D or obesity,” said Kitty Yale, chief development
officer of Akero. “We look forward to continuing the development
and assessment of EFX in our Phase 3 SYNCHRONY Histology and
SYNCHRONY Real-World studies which are currently enrolling patients
including those on stable GLP-1RA therapy.”
About EfruxiferminEfruxifermin (EFX), Akero’s
lead product candidate for MASH, 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 appears 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 MASH, including improvements in
lipoprotein risk factors linked to cardiovascular disease – the
leading cause of death in MASH patients. 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 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. Approximately 20% of patients with
MASH will progress to cirrhosis, which has a higher risk of
mortality. There are no approved treatments for the condition and
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, a disease without any approved
therapies. Akero's lead product candidate, EFX, is currently being
evaluated in 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
or MASLD. A third clinical trial, the SYNCHRONY Outcomes study in
patients with cirrhosis due to MASH, is expected to be initiated in
the first half 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 and the SYMMETRY study in patients
with cirrhosis due to MASH. 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; the timing and enrollment 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:Sarah
O’Connell732.456.0092soconnell@vergescientific.com
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