Akero Therapeutics to Present Late-Breaking Oral and Poster Presentations on EFX at AASLD’s The Liver Meeting® 2023
November 10 2023 - 8:57AM
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 it will present a late-breaking oral presentation and a
poster featuring its lead product candidate efruxifermin (EFX) at
the American Association for the Study of Liver Diseases’ (AASLD)
The Liver Meeting® 2023 being held November 10-14 in Boston, MA.
The oral presentation will detail a recently announced 36-week
analysis of SYMMETRY, a 96-week Phase 2b study evaluating the
efficacy and safety of EFX in patients with compensated cirrhosis
(F4) due to metabolic dysfunction-associated steatohepatitis
(NASH/MASH). A new analysis of a subgroup comprised of 84 patients
diagnosed with cirrhosis due to NASH/MASH at least 6 months before
treatment with EFX or those with cryptogenic cirrhosis at baseline
provides further evidence of EFX’s activity in this advanced
cirrhotic population, with a trend to higher rates of fibrosis
improvement without NASH/MASH worsening in 10% and 22% of those
treated with 28mg and 50mg EFX, respectively, compared to 3% for
placebo. Another analysis of the 36-week SYMMETRY study data showed
that the trend for EFX to reverse cirrhosis did not appear to be
attributable to concomitant use of GLP-1.
The poster describes data from SYMMETRY Cohort D, which
evaluated treatment of EFX in combination with a GLP-1 receptor
agonist in patients with F1-F3 NASH/MASH and Type 2 diabetes. The
poster also includes subgroup analyses from HARMONY showing that
improvements in liver histology among F2-F3 NASH/MASH patients
associated with EFX treatment with EFX, do not appear to be
attributable to concomitant use of GLP-1.
EFX was reported to be generally well-tolerated in the SYMMETRY
main study and Cohort D. Overall, the most frequent adverse events
were transient, mild-to-moderate gastro-intestinal grade 1 or 2
events.
“Analyses of data from the SYMMETRY and HARMONY Phase 2b
studies, which will be presented at The Liver Meeting®, underscore
EFX’s promising activity profile and support continued development
in both the pre-cirrhotic and cirrhotic NASH/MASH patient
populations,” said Kitty Yale, chief development officer of Akero.
“Although the primary endpoint of fibrosis improvement without
worsening of NASH/MASH was not met in SYMMETRY, we remain
encouraged by the totality of data and consistency of EFX’s
anti-fibrotic effects by either histopathology or non-invasive
tests evident across four 4 separate cohorts in patients with
pre-cirrhotic (F1-F3) and cirrhotic (F4) NASH/MASH. We therefore
believe that longer periods of treatment with EFX may result in
higher rates of fibrosis improvement, including cirrhosis reversal.
We are also encouraged that EFX appears to provide additional
benefit when dosed on top of GLP-1 therapy.”
Details of the presentations are as follows:
Oral Presentation Title: Efruxifermin in
Compensated Cirrhosis due to NASH/MASH: Results from a Randomized,
Double-blind, Placebo-controlled, Phase 2b Trial (SYMMETRY)
- Presenter: Stephen A. Harrison, M.D., Medical
Director, Pinnacle Clinical Research and principal investigator for
the SYMMETRY study
- Late Breaker Abstract Number: 5005
- Session Title: Late Breaking Abstract #1
- Presentation Type: Oral, Late Breaking
Parallel Session
- Session Date and Time: Monday, November 13,
2023, 2:00 PM - 3:30 PM
- Presentation Time: 3:15 PM
- Location: General Session Ballroom ABC
Poster Presentation Title: Safety and Efficacy
of Efruxifermin in Combination With a GLP-1 Receptor Agonist
(GLP-1RA) in Patients with NASH/MASH and T2D: a Randomized,
Placebo-controlled Study (Cohort D)
- Presenter: Stephen A. Harrison, M.D., Medical
Director, Pinnacle Clinical Research and principal investigator for
the SYMMETRY Cohort D study
- Late Breaker Abstract Number: 48626
- Presentation Type: Late Breaking Poster
Presentation
- Presentation Time: Monday, November 13: 1:00
PM – 2:00 PM
- Location: Poster Hall
About NASH/MASHNASH/MASH is a serious form of
non-alcoholic fatty liver disease (NAFLD) that is estimated to
affect 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 NASH/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 SYMMETRY The Phase 2b SYMMETRY main study
is a multicenter, randomized, double-blind, placebo-controlled,
clinical trial in biopsy-confirmed NASH/MASH patients with
compensated cirrhosis (F4, Child-Pugh class A). One hundred
eighty-two patients have been randomized to receive once-weekly
subcutaneous dosing of 28mg EFX, 50mg EFX, or placebo. The primary
endpoint for the trial was the proportion of subjects who achieve ≥
1 stage improvement in fibrosis with no worsening of NASH/MASH at
week 36. Patients are continuing as randomized to receive EFX or
placebo for up to 96 weeks.
About EfruxiferminEfruxifermin is Akero’s lead
product candidate for NASH/MASH, 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 MASH, including improvements in lipoprotein risk factors
linked to cardiovascular disease – the leading cause of death in
NASH/MASH 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/MASH, 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 ongoing, 96-week Phase 2b clinical trials: the HARMONY study
in patients with pre-cirrhotic NASH/MASH (F2-F3 fibrosis), and the
SYMMETRY study in patients with cirrhotic NASH/MASH (F4 fibrosis,
compensated). Screening began in the first two of three Phase 3
clinical trials in September 2023, known as the SYNCHRONY Histology
and SYNCHRONY Real-World studies. 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 and efficacy of EFX, as well as the dosing, safety and
tolerability of EFX; and upcoming milestones, including the
results, and expected timing to report the long-term follow-up week
96 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
Akero Therapeutics (NASDAQ:AKRO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Akero Therapeutics (NASDAQ:AKRO)
Historical Stock Chart
From Jul 2023 to Jul 2024