Aligos Therapeutics Announces First Subjects Dosed in the Phase 2a HERALD Study of ALG-055009 in MASH Subjects
03 Avril 2024 - 2:00PM
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 that dosing in the Phase 2a HERALD study
of ALG-055009 has been initiated in subjects with metabolic
dysfunction-associated steatohepatitis (MASH).
“Dosing the first subjects in our Phase 2a HERALD study is an
important milestone for Aligos,” said Lawrence Blatt, Ph.D., MBA,
Chairman, President, and Chief Executive Officer at Aligos
Therapeutics. “We are pleased by the engagement of the clinicians
and subjects, demonstrating the need for additional oral MASH
therapies. We look forward to continuing to advance this potent,
potential best-in-class drug candidate through the clinic.”
HERALD (NCT06342947) is a randomized, placebo-controlled trial
that will enroll ~100 subjects with presumed MASH and stage 1-3
liver fibrosis (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 for 12 weeks. In addition to
collecting safety and pharmacokinetic (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. Topline safety and
efficacy data from this study are expected in Q4 2024.
About ALG-055009 ALG-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 begun dosing in 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).
Topline safety and efficacy data from this study are expected in Q4
2024.
About MASH One 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.
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 hepatitis B 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, with
respect to ALG-055009, the company looking forward to continuing to
advance it through the clinic, it being a potential best-in-class
THR-ß agonist drug candidate and the expectation of topline safety
and efficacy data from the HERALD study in Q4 2024; and, with
respect to MASH, the estimated occurrences of each of MASLD and
MASH globally, the projected prevalence of MASH in the United
States, and the possibility of cirrhosis resulting from the
inflammation inherent in MASH in the absence of changes in diet and
exercise. 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.
Contacts
CompanyJordyn TaraziVice President, Investor
Relations & Corporate Communications(650)
910-0427jtarazi@Aligos.com
MediaMichael Fitzhugh LifeSci Communications
mfitzhugh@lifescicomms.com
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