Aligos Therapeutics Announces the Completion of Enrollment in the ALG-055009 Phase 2a HERALD Study for the Treatment of MASH
Aligos Therapeutics (Nasdaq: ALGS) has completed enrollment for its Phase 2a HERALD study of ALG-055009, targeting metabolic dysfunction-associated steatohepatitis (MASH). The study enrolled around 100 subjects with liver fibrosis. Topline safety and efficacy data are expected in early Q4 2024.
Dr. Rohit Loomba, a renowned expert in gastroenterology and hepatology, will serve as the Principal Investigator. The trial involves a double-blind, placebo-controlled design with subjects receiving one of four doses or placebo for 12 weeks. The primary endpoint is the relative change in liver fat content measured by MRI-PDFF.
The study aims to assess safety, pharmacokinetics, and other non-invasive biomarkers influenced by thyroid hormone receptor beta agonists. The completion of enrollment is a significant milestone for Aligos.
- Completed enrollment for Phase 2a HERALD study.
- Topline data expected in early Q4 2024.
- Study targets MASH, a condition with unmet medical needs.
- Involves approximately 100 subjects, providing robust data.
- Principal Investigator Dr. Rohit Loomba is a recognized expert in the field.
- Double-blind, placebo-controlled design strengthens study validity.
- Multiple dosing arms increase the comprehensiveness of the study.
- Focus on non-invasive MRI-PDFF to measure liver fat content.
- Topline data not available until early Q4 2024, delaying potential market impact.
- Relatively small sample size (100 subjects) may not capture all variabilities.
- Study duration of 12 weeks may be too short to observe long-term effects.
- Dependence on non-invasive biomarkers, which may not fully capture all clinical outcomes.
- Potential for placebo effect impacting the results.
Insights
The completion of enrollment in the Phase 2a HERALD study marks an important milestone in Aligos Therapeutics' quest to develop a treatment for metabolic dysfunction-associated steatohepatitis (MASH). This marks a important moment, as it transitions the company from patient recruitment to data analysis, which could potentially reveal significant insights into the efficacy and safety of ALG-055009.
Given the prevalence and lack of effective treatments for MASH, a condition closely linked to obesity and type 2 diabetes, any promising data from this trial could position Aligos as a leader in this therapeutic area. The expertise of Dr. Rohit Loomba, who has pioneered non-invasive methods to assess liver steatosis, could enhance the credibility and accuracy of the study's findings.
From an investor’s perspective, the anticipated release of topline data in early Q4 2024 should be closely monitored. Positive outcomes could drive significant interest and investment, pushing stock prices higher. Conversely, unfavorable results could dampen market enthusiasm.
Understanding the methodology of the study, which includes the use of MRI-PDFF to measure liver fat content, is crucial. This non-invasive biomarker is a reliable indicator of liver health and could streamline future clinical evaluations if proved successful.
For Aligos Therapeutics, the completion of enrollment in this Phase 2a trial provides a pivotal development timeline for investors. The projected release of topline data in early Q4 2024 creates a clear horizon for potential stock price movement based on trial results.
The fact that this is Aligos’ first Phase 2a trial completion signals a significant step forward in their R&D pipeline, potentially increasing investor confidence. Successful outcomes could pave the way for Phase 3 trials, which, if positive, might lead to eventual FDA approval and market entry, fostering potential future revenue streams.
However, investors should also weigh the risk factors. Clinical trials are inherently uncertain and the failure to meet primary endpoints could negatively impact the company's valuation. Additionally, the competitive landscape for MASH treatments is becoming crowded and Aligos must demonstrate superior efficacy or safety profiles to stand out.
It's also worth analyzing the financial health and burn rate of Aligos. Sustained R&D investments without prompt positive outcomes could strain the company's cash reserves, possibly leading to future capital raises that could dilute existing shareholders.
Topline data now projected in early Q4 2024
Rohit Loomba, MD, MHSc to serve as Principal Investigator
SOUTH SAN FRANCISCO, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- 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
About Aligos
Aligos 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
Company
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
(650) 910-0427
jtarazi@Aligos.com
Media
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
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