Aligos Therapeutics Announces First Subjects Dosed in the Phase 2a HERALD Study of ALG-055009 in MASH Subjects
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Initiation of Phase 2a trials in biopharmaceutical development marks a pivotal point where a drug candidate like ALG-055009 transitions from early-stage research to mid-stage testing, where its safety and efficacy are evaluated in a larger group of participants. The focus on metabolic dysfunction-associated steatohepatitis (MASH) is particularly significant given the limited treatment options currently available. This therapeutic area has been garnering interest due to the rising prevalence of liver diseases linked to obesity and diabetes.
Investors might view the progression of ALG-055009 into Phase 2a as a positive signal, potentially leading to increased stock volatility. The trial's design, which includes multiple doses and non-invasive biomarkers like MRI-PDFF, aims to provide a comprehensive assessment of the drug's impact. The use of non-invasive biomarkers is a modern approach that can improve the predictability of the trial outcomes and potentially shorten the time to market for successful candidates.
However, it's essential to note that the biopharmaceutical sector is highly speculative and the majority of drug candidates do not make it to market. The long-term implications will depend on the topline safety and efficacy data expected in Q4 2024. Positive results could lead to a significant appreciation in Aligos Therapeutics' market value, while negative results could have the opposite effect.
From an investment perspective, the initiation of the HERALD study is a key event that could influence Aligos Therapeutics' financial health. The market for MASH therapies is underserved and a potential best-in-class drug candidate like ALG-055009 could capture a significant market share if approved. The trial's success would likely attract partnership opportunities, licensing deals, or even buyout offers from larger pharmaceutical companies looking to expand their liver disease portfolios.
Investors should monitor the enrollment rate and interim data releases, as these can offer early indications of the trial's progress and the drug's potential. The enrollment of ~100 subjects is relatively small, which could lead to faster completion of the trial but also may limit the diversity of the patient population and the generalizability of the results.
It is also worth noting that Aligos Therapeutics' stock price may experience increased sensitivity to news related to this study. Any delays, safety concerns, or early signs of inefficacy could lead to stock price volatility. On the other hand, positive interim results or announcements indicating a smooth progression of the trial could provide upward momentum for the stock.
From a scientific standpoint, the HERALD study's methodology reflects a rigorous approach to drug development. The use of a placebo-controlled, randomized trial design is the gold standard for determining a drug's efficacy. The inclusion of a range of doses allows for the determination of the optimal therapeutic window with the lowest incidence of side effects. The decision to use non-invasive biomarkers, such as MRI-PDFF, aligns with current trends in clinical research, offering a less burdensome and potentially more accurate assessment of liver fat content than invasive liver biopsies.
Furthermore, the study's focus on thyroid hormone receptor beta (THR-ß) agonists is noteworthy. These compounds have shown promise in modulating liver metabolism and improving liver health, which could position ALG-055009 as a novel and effective treatment option for MASH. However, the therapeutic efficacy and safety profile of THR-ß agonists in a broader patient population remain to be seen and will be important for the success of ALG-055009.
Stakeholders should be aware that the transition from Phase 2a to Phase 3 trials is contingent upon demonstrating significant improvement in biomarkers and safety profiles. Thus, while the initiation of the HERALD study is a positive development, the long road to regulatory approval and commercialization is fraught with scientific and regulatory hurdles that must be successfully navigated.
SOUTH SAN FRANCISCO, Calif., April 03, 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 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
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 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
Company
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
(650) 910-0427
jtarazi@Aligos.com
Media
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
