Akero Therapeutics to Present Topline Week 96 Results from Phase 2b HARMONY Study Investigating Efruxifermin in Patients with Pre-Cirrhotic MASH
01 March 2024 - 12:00AM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company
developing transformational treatments for patients with serious
metabolic disease, will hold an investor conference on Monday,
March 4 at 8:00 a.m. ET to share results after 96 weeks of
treatment for its HARMONY study, a double-blind, placebo-controlled
Phase 2b study evaluating the efficacy of efruxifermin (EFX) in
patients with pre-cirrhotic metabolic dysfunction-associated
steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3).
Conference Call / Webcast DetailsThe company
will host a conference call and webcast with slide presentation at
8:00 a.m. ET on Monday, March 4. Please click
here to register for the event.
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 HARMONY The Phase 2b HARMONY study was a
multicenter, randomized, double-blind, placebo-controlled,
dose-ranging trial in biopsy-confirmed adult patients with
pre-cirrhotic MASH (F2-F3). The study enrolled a total of 128
patients, randomized to receive once-weekly subcutaneous dosing of
28mg or 50mg EFX, or placebo. 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 MASH at week
24. Week 96 histology endpoints included the proportion of subjects
who achieved at least a one-stage improvement in fibrosis without
worsening of MASH, a two-stage improvement in fibrosis without
worsening of MASH, MASH resolution without fibrosis worsening, and
a combination of fibrosis improvement and MASH resolution.
Additional secondary measures included change from baseline
for noninvasive markers of liver fibrosis, liver enzymes,
markers of glycemic control, lipoproteins and body weight as well
as safety and tolerability measures.
In September 2022, Akero reported positive results from the
study after 24 weeks of EFX treatment, demonstrating both the 50mg
and 28mg EFX doses achieved statistical significance on the primary
endpoint as well as secondary histology endpoints. 41% and 39% of
patients treated with 50mg and 28mg EFX, respectively, experienced
at least a one-stage improvement in liver fibrosis with no
worsening of MASH by week 24, approximately double the placebo rate
of 20%. 76% and 47% of patients treated with 50mg and 28mg EFX,
respectively, experienced MASH resolution without worsening of
fibrosis, three to five times the placebo rate of 15%. 41% and 29%
of patients treated with 50mg and 28mg EFX, respectively,
experienced both MASH resolution and fibrosis improvement ≥1 stage,
approximately six to eight times the placebo rate of 5%.
EFX-treated patients also experienced statistically significant
improvements in liver fat, liver enzymes, noninvasive markers
of fibrosis, glycemic control, lipoproteins, and body weight. EFX
was reported to be generally well-tolerated. Across both dose
groups, the most frequent adverse events were grade 1 or 2
gastrointestinal events (diarrhea, nausea, increased appetite, and
frequent bowel movements), which were transient in nature.
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 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 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 projected to affect over 25 million Americans by 2030. 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 United States 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) 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 (F4), 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; the
potential therapeutic effects of EFX, as well as the dosing, safety
and tolerability of EFX; the SYNCHRONY Phase 3 program, including
the timing of the SYNCHRONY Outcomes studies; and upcoming
milestones, including the results, and expected timing to report
the week 96 results of Akero’s Phase 2b HARMONY 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:Christina
Tartaglia212.362.1200IR@akerotx.com
Media Contact:Sarah
O’Connell732.456.0092soconnell@vergescientific.com
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