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 released
topline data from an expansion cohort (N=31) of the Phase 2b
SYMMETRY study known as Cohort D. The primary aim of the 12-week
study was to assess safety and tolerability of Akero’s lead product
candidate, efruxifermin (EFX), compared to placebo when added to an
existing GLP-1 receptor agonist (GLP-1) in patients with Type 2
diabetes (T2D) and F1-F3 liver fibrosis due to non-alcoholic
steatohepatitis (NASH).
EFX was reported to be generally well tolerated in Cohort D with
comparable results for the EFX (N=21) and placebo (N=10) groups.
The overall tolerability profile was similar to that observed in
Akero’s BALANCED and HARMONY studies. 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 discontinued after withdrawing consent. There were no
drug-related serious adverse events.
Cohort D also met all key secondary endpoints, including
relative reduction of liver fat and proportion of patients whose
absolute liver fat level normalized to 5 percent or less. We
believe these data, together with statistically significant
improvements across many other key NASH-related measures, show that
EFX could be an important treatment for patients with NASH who are
being treated with GLP-1 for T2D or obesity.
“A substantial portion of patients who have NASH are obese and
have Type 2 diabetes, with utilization of GLP-1 therapies
increasing rapidly to treat these underlying comorbidities”, said
Stephen Harrison, M.D., chairman and founder of Pinnacle Clinical
Research and principal investigator for the SYMMETRY study. “With
this in mind, it is highly encouraging that the Cohort D results
not only showed that EFX combined with GLP-1 appeared to be
adequately tolerated, but also the combination offered substantial
benefit over GLP-1 therapy alone based on multiple key NASH
endpoints. Hepatic steatosis was still present in patients on GLP-1
therapy, approximately two-thirds of whom were treated with GLP-1
for over one year, and 88% of patients resolved hepatic steatosis
completely when EFX was added.”
“We’re highly encouraged by the strength and consistency of
results across our Phase 2 studies to date,” said Kitty Yale, chief
development officer of Akero. “With the added support of this
newest data set, we believe EFX has the potential to play an
important role in treating patients with NASH who are receiving
GLP-1 therapy in addition to the potential to be a foundational
monotherapy for patients with NASH. We look forward to initiating
two Phase 3 SYNCHRONY studies later this year to further our goal
of addressing high unmet need across the globe for patients living
with NASH.”
Summary of Week 12 Changes in Liver
Fat
Measure |
Placebo(N=10) |
EFX 50mg (N=16) |
Hepatic Fat Fraction (MRI-PDFF) (%), LS Mean Relative Change from
Baseline |
-10 |
-65 *** |
Proportion of patients achieving ≥50% Relative Reduction in Liver
Fat (%) |
0 |
88 *** |
Proportion of patients with Normalized (≤5%) Liver Fat (%) |
10 |
88*** |
*** p<0.001, versus placebo (ANCOVA)
Summary of Key Markers of Fibrosis and Liver Injury, LS
Mean Absolute Change from Baseline to Week 12
Measure |
Placebo(N=10) |
EFX 50mg (N=21) |
Pro-C3 (µg/L) |
-2.7 |
-5.2 †† |
ELF Score |
+0.1 |
-0.6 ** |
Liver Stiffness (kPa) (FibroScan) |
-1.1 |
-3.0 ††† |
FAST Score |
+0.04 |
-0.16 *** |
ALT (U/L) |
-1.0 |
-10 * |
AST (U/L) |
+1.5 |
-5.3 * |
* p<0.05, ** p<0.01, *** p<0.001, versus placebo (Mixed
Model Repeated Measures [MMRM])†† p<0.01, ††† p<0.001, versus
baseline (MMRM)
Summary of Key Cardio-Metabolic Biomarkers, LS Mean
Relative Change from Baseline to Week 12
Measure |
Placebo(N=10) |
EFX 50mg (N=21) |
HbA1c (%, absolute) |
-0.2 |
-0.5 ††† |
Insulin (%) |
-13 |
-26 |
C-Peptide (%) |
-3.5 |
-22 † |
Adiponectin (%) |
+16 |
+129 *** |
Triglycerides (%) |
-4.1 |
-42 *** |
Non-HDL Cholesterol (%) |
-6.8 |
-19 ††† |
Apolipoprotein B (%) |
-4.5 |
-21 * |
LDL Cholesterol (%) |
-6.1 |
-8.0 |
HDL Cholesterol (%) |
+2.5 |
+38 *** |
Body Weight (kg) |
-0.8 |
-1.2 |
** p<0.01, *** p<0.001, versus placebo (MMRM)† p<0.05,
††† p<0.001, versus baseline (MMRM)
In July of 2021, Akero initiated the SYMMETRY main study, a
Phase 2b trial in biopsy-confirmed NASH patients with compensated
cirrhosis (F4), Child-Pugh class A. Akero expects to report results
from the ongoing study in the fourth quarter of 2023.
Conference Call / Webcast DetailsAkero will
host a conference call and webcast with slide presentation at 8:00
a.m. ET today. The live webcast will be available on the Events
& Presentations page of the Akero website, with the recording
and presentation available immediately following the event.
About NASHNASH is a serious form of NAFLD
(non-alcoholic fatty liver disease) 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), formerly
known as AKR-001, 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. 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 pre-cirrhotic NASH (F2-F3 fibrosis), and the
SYMMETRY study in patients with cirrhotic NASH (F4 fibrosis,
compensated). EFX is also being evaluated in an expansion cohort of
the SYMMETRY study, comparing the 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 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, including in combination with GLP-1 therapies; and upcoming
milestones, including the results, and expected timing to report
such 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 a clinical study, including Cohort D, 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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