Aligos Therapeutics Announces the Completion of Enrollment in the ALG-055009 Phase 2a HERALD Study for the Treatment of MASH
21 Mayo 2024 - 7:00AM
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 it has completed enrollment in the
ALG-055009 Phase 2a HERALD study for metabolic
dysfunction-associated steatohepatitis (MASH) with topline safety
and efficacy data anticipated in early Q4 2024. The company also
announced that Dr. Rohit Loomba will serve as Principal
Investigator for the study.
“Completing enrollment in our first Phase 2a trial is a
tremendous accomplishment for the Aligos team,” said Lawrence
Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer
at Aligos Therapeutics. “We thank the patients, their families and
our investigators for their efforts. In addition, I’d like to
welcome Dr. Rohit Loomba as our Principal Investigator for the
HERALD study. Dr. Loomba has a broad track record of contributions
to the MASH field, having pioneered the use of MRI-PDFF as a
noninvasive test to assess liver steatosis. We look forward to his
insights and contributions to the HERALD study and beyond.”
Dr. Loomba is the Chief of the Division of Gastroenterology and
Hepatology and Professor of Medicine at the University of
California, San Diego (UCSD). He is also the Director of the UCSD
NAFLD Research Center. Dr. Loomba completed a fellowship in
gastroenterology at the UC San Diego School of Medicine and a
fellowship in hepatology at the National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK). Dr. Loomba earned his medical degree from the Armed Forces
Medical College in India and a Master of Health Science in clinical
research from Duke University School of Medicine.
“I am pleased to serve as the Principal Investigator for the
Phase 2a HERALD study,” stated Rohit Loomba, MD, MHSc, Chief,
Division of Gastroenterology and Hepatology, University of
California, San Diego. “The excellent potency and PK profile makes
ALG-055009 a compelling potential treatment option for MASH
patients. I look forward to working with the team to complete this
study.”
HERALD (NCT06342947) is a randomized, double-blind,
placebo-controlled trial that has enrolled approximately 100
subjects with presumed MASH and stage 1-3 liver fibrosis (F1-F3).
Subjects were 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. The primary endpoint is relative
change in liver fat content by Magnetic Resonance Imaging Proton
Density Fat Fraction (MRI-PDFF) at week 12. Safety,
pharmacokinetics (PK) and other non-invasive biomarkers/tests
previously shown to be impacted by treatment with thyroid hormone
receptor beta (THR-ß) agonists will also be evaluated.
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 fully enrolled 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 early 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 Statements 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,
statements regarding Aligos’ research and development activities,
including the expected timing of topline data from the Phase 2a
HERALD Study. 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, and other matters that
could affect the sufficiency of Aligos’ capital resources to fund
operations. 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’
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 7, 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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