Aligos Therapeutics Announces the Initiation of the Phase 2a HERALD Study of ALG-055009 in MASH Subjects
18 Mars 2024 - 1:00PM
Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical
stage biopharmaceutical company focused on developing novel
therapeutics to address unmet medical needs in liver and viral
diseases, today announced the initiation of the Phase 2a HERALD
study of ALG-055009 in subjects with metabolic
dysfunction-associated steatohepatitis (MASH). Screening of
subjects has begun at clinical study sites across the U.S.
“ALG-055009 has enhanced potency, greater beta selectivity, and
a favorable PK profile. We believe that these optimized
pharmacologic properties may result in improved therapeutic
outcomes for patients living with MASH. The initiation of the
HERALD study is an important next step in achieving our goal to
create a best-in-class thyroid hormone receptor beta agonist,”
stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and CEO of
Aligos Therapeutics. “This is an exciting time in the MASH space
with the first drug recently approved, but we believe there is
still a need for additional treatment options. We look forward to
sharing topline HERALD data in Q4 this year.”
The 12-week randomized, placebo-controlled trial will enroll 100
subjects with presumed MASH and liver fibrosis at stages 1-3
(F1-F3). Subjects will be randomized to receive one of four doses
(0.3, 0.5, 0.7, 0.9 mg) of ALG-055009 or placebo (~20 subjects/arm)
given orally once daily. In addition to collecting safety and
pharmacokinetics (PK) data, this study will also assess multiple
non-invasive biomarkers, which include Magnetic Resonance Imaging
Proton Density Fat Fraction (MRI-PDFF) and other tests previously
shown to be impacted by treatment with thyroid hormone receptor
beta (THR-ß) agonists. Dosing is anticipated to begin in Q2 2024
and topline safety and efficacy data from this study is expected in
Q4 2024.
About ALG-055009ALG-055009 appears to be a
best-in-class thyroid hormone receptor beta (THR-ß) agonist
discovered by Aligos for the treatment of metabolic
dysfunction-associated steatohepatitis (MASH). ALG-055009 recently
completed a Phase 1 first in human study, with preliminary data
after single and multiple daily doses showing that ALG-055009 was
well tolerated, had dose proportional pharmacokinetics (PK) and low
variability, and demonstrated expected thyromimetic effects. Aligos
has initiated the Phase 2a HERALD study of ALG-055009 to assess
safety, PK, and multiple efficacy biomarkers such as Magnetic
Resonance Imaging Proton Density Fat Fraction (MRI-PDFF). Dosing is
anticipated to begin in Q2 2024 and topline safety and efficacy
data from this study is expected in Q4 2024.
About MASHOne of the effects of improper diet
and insufficient exercise is the accumulation of fatty deposits in
the liver, referred to as metabolic dysfunction-associated
steatotic liver disease (MASLD), which was estimated to occur in
approximately 30% of the worldwide population as of 2019. An
estimated 1.5% to 6.5% of the global population is believed to have
an ongoing inflammatory response to these excess fat deposits,
which is referred to as metabolic dysfunction-associated
steatohepatitis (MASH). In the United States alone, the prevalence
of MASH is projected to increase from approximately 16.5 million in
2015 to 27.0 million in 2030. In the absence of changes in diet and
exercise, the inflammation inherent in MASH persists and may result
in progressive fibrosis of the liver, which may result in
cirrhosis. These fibrotic changes are associated with numerous
morbidities including recurrent hospitalization for complications
of cirrhosis, hepatocellular carcinoma, need for liver transplant,
and death. The first drug to treat this growing patient population,
a THR-ß agonist, was recently approved for the treatment of
MASH.
About AligosAligos Therapeutics, Inc. is a
clinical stage biopharmaceutical company that was founded in 2018
with the mission to become a world leader in the treatment of liver
and viral diseases. Aligos’ strategy is to harness the deep
expertise and decades of drug development experience its team has
in liver and viral diseases to discover and develop potentially
best-in-class therapeutics for metabolic dysfunction-associated
steatohepatitis (MASH) and viruses with high unmet medical need
such as chronic hepatitis B (CHB) and coronaviruses.
Forward-Looking Statement This press release
contains forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995. Any statements in
this press release that are not historical facts may be considered
“forward-looking statements,” including without limitation, the
anticipation that the first subject will be dosed in the HERALD
study in Q2 2024 with topline safety and efficacy data expected in
Q4 2024 and the company looking forward to sharing such data in Q4
2024; the belief that the enhanced potency, greater beta
selectivity, and favorable PK profile of ALG-055009 may result in
improved therapeutic outcomes for patients living with MASH; the
initiation of the HERALD study being an important step in achieving
the goal of creating a best-in-class thyroid hormone receptor beta
agonist; the belief that there is still a need for additional
treatment options in the MASH space; and the estimation and
projection of the prevalence of the MASH patient population.
Forward-looking statements are typically, but not always,
identified by the use of words such as “may,” “will,” “would,”
“believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,”
and other similar terminology indicating future results. Such
forward looking statements are subject to substantial risks and
uncertainties that could cause our development programs, future
results, performance, or achievements to differ materially from
those anticipated in the forward-looking statements. Such risks and
uncertainties include, without limitation, risks and uncertainties
inherent in the drug development process, including Aligos’
clinical-stage of development, the process of designing and
conducting clinical trials, the regulatory approval processes, the
timing of regulatory filings, the challenges associated with
manufacturing drug products, Aligos’ ability to successfully
establish, protect and defend its intellectual property, other
matters that could affect the sufficiency of Aligos’ capital
resources to fund operations, reliance on third parties for
manufacturing and development efforts, and the impact of global
events and other macroeconomic conditions on the Aligos’ business.
For a further description of the risks and uncertainties that could
cause actual results to differ from those anticipated in these
forward-looking statements, as well as risks relating to the
business of Aligos in general, see Aligos’ Annual Report on Form
10-K filed with the Securities and Exchange Commission on March 12,
2024 and its future periodic reports to be filed or submitted with
the Securities and Exchange Commission. Except as required by law,
Aligos undertakes no obligation to update any forward-looking
statements to reflect new information, events or circumstances, or
to reflect the occurrence of unanticipated events.
CompanyJordyn TaraziVice President, Investor
Relations & Corporate Communications(650)
910-0427jtarazi@Aligos.com
MediaMichael FitzhughLifeSci
Communicationsmfitzhugh@lifescicomms.com
Aligos Therapeutics (NASDAQ:ALGS)
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