Akero Therapeutics Completes Enrollment of Phase 2b SYMMETRY Study and Announces Expected 2023 Milestones
December 21 2022 - 3:01PM
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 that it has completed enrollment of the Phase 2b SYMMETRY
main study evaluating efruxifermin (EFX) for the treatment of
non-alcoholic steatohepatitis (NASH), in patients with compensated
cirrhosis fibrosis stage 4 (F4). Enrollment is also complete for
the expansion cohort, known as Cohort D, evaluating EFX in
combination with GLP-1 therapy in patients with fibrosis stage 1-3
(F1-F3) and Type 2 Diabetes Mellitus (T2D).
“We are encouraged by the strength of our EFX data to date,
including histology data from a Phase 2a proof-of-concept study in
patients with cirrhosis due to NASH, and believe EFX has the
potential to show favorable histology results in the SYMMETRY main
study despite other investigational drugs having shown limited
efficacy,” said Andrew Cheng, M.D., Ph.D., president and chief
executive officer of Akero. “We look forward to reporting SYMMETRY
data later next year as we evaluate EFX’s potential to slow or
reverse progression of cirrhosis.”
The Phase 2b SYMMETRY main study is a multicenter, randomized,
double-blind, placebo-controlled, clinical trial in
biopsy-confirmed NASH 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 is
fibrosis regression after 36 weeks treatment. Secondary measures
include change from baseline in liver enzymes, liver fat,
lipoproteins, glycemic control, and body weight at 36 weeks, as
well as evaluation of safety and tolerability. To provide
additional safety data from long-term follow up, patients will
continue to receive EFX or placebo from 36 to 96 weeks.
The primary goal of the 12-week Cohort D expansion, in which 32
patients have been randomized, is to assess safety and tolerability
of EFX compared to placebo when added to an existing GLP-1 receptor
agonist in patients with T2D and F1-F3 liver fibrosis due to NASH.
Demonstrating that EFX could accelerate NASH resolution and
reversal of fibrosis among those patients already on GLP-1 therapy
would help address an important unmet medical need.
Consistent with prior guidance, results from the Cohort D
expansion cohort are expected in the second quarter of 2023, while
results from the main study remain on track to be reported in the
fourth quarter of 2023.
Following designation of EFX as a Breakthrough Therapy by the
FDA, an End-of-Phase 2 meeting has been scheduled for March 2023 to
review the HARMONY F2/3 data as well as the proposed Ph3 clinical
program.
About NASHNASH (non-alcoholic steatohepatitis)
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 a leading cause of liver transplants 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 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 offers 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 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 www.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; and upcoming milestones, including the
results, and expected timing to report such results of Akero’s
Phase 2b SYMMETRY study and the Cohort D expansion cohort; the
potential benefits resulting from the Breakthrough Therapy
Designation of EFX and related implications; and the timing and
expectations around regulatory interactions, including planned
meetings with the FDA to discuss the development of EFX. 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 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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