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Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical-stage biopharmaceutical company headquartered in South San Francisco, California, and founded in 2018. The company is dedicated to developing novel therapeutics to address unmet medical needs in liver and viral diseases. Aligos is particularly focused on treatments for chronic hepatitis B (CHB) and metabolic dysfunction-associated steatohepatitis (MASH), as well as for coronaviruses.
The company’s lead candidate, ALG-010133, is a synthetic oligonucleotide currently in Phase I clinical trial for the treatment of CHB. Other promising candidates in their pipeline include ALG-000184, a capsid assembly modulator also targeting CHB, and ALG-055009, a small molecule thyroid hormone receptor beta (THR-ß) agonist for MASH. Initial studies on ALG-055009 have demonstrated enhanced potency and favorable pharmacokinetics.
Aligos is advancing its clinical programs, including the Phase 2a HERALD study of ALG-055009, which will assess the safety and efficacy of the drug in subjects with MASH, with topline data expected in Q4 2024. The study aims to enroll about 100 subjects and will evaluate multiple non-invasive biomarkers to track liver health improvements.
The company is also actively engaged in collaborations and partnerships to bolster its research efforts. Recently, Aligos presented positive data at the European Association for the Study of the Liver (EASL) Congress 2024, showcasing the sustained antiviral activity of ALG-000184 in both HBeAg-positive and HBeAg-negative CHB subjects. This data represents a significant advancement in viral load suppression and demonstrates Aligos' potential to deliver best-in-class treatments.
Besides its focus on liver diseases, Aligos is developing ALG-097558, a pan-coronavirus protease inhibitor showing promise in preclinical and early clinical trials. ALG-097558 has been well tolerated and does not require ritonavir boosting, addressing a critical need for effective, easily administered antiviral therapies.
Financially, Aligos reported cash, cash equivalents, and investments totaling $112.7 million as of March 31, 2024. The company continues to secure funding to support its operations and further its research projects, with a belief that its current cash balance will sustain operations through the end of 2025.
Aligos’ mission is to leverage its deep expertise and innovative approaches in drug development to become a leader in treating liver and viral diseases, ultimately improving patient outcomes and addressing high unmet medical needs worldwide.
Aligos Therapeutics (Nasdaq: ALGS) has announced a clinical trial collaboration with Xiamen Amoytop Biotech to evaluate the combination of ALG-000184 and PEGBING® (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. Amoytop will sponsor a Phase 1b exploratory study to assess the efficacy and safety of this combination.
ALG-000184 is a potent oral capsid assembly modulator (CAM-E) designed to disrupt hepatitis B cccDNA levels and reduce viral markers. It has shown promising results in Phase 1a and 1b studies. PEGBING®, developed by Amoytop, is a 40kD pegylated interferon α-2b injection used in viral hepatitis treatment.
The 48-week Phase 1b study will compare ALG-000184 + PEGBING® + entecavir (ETV) with ALG-000184 + ETV or PEGBING® + ETV in HBeAg-positive and HBeAg-negative CHB subjects.
Aligos Therapeutics announced a virtual KOL event on July 18, 2024, featuring Dr. Mark Sulkowski to discuss positive Phase 1b data for ALG-000184 in treating chronic hepatitis B (CHB). The event will cover the unmet needs in CHB treatment, current landscape, and future development plans following positive FDA feedback. Aligos' CEO, Lawrence Blatt, highlighted the promising results of ALG-000184 monotherapy, showing significant viral suppression without breakthrough, and its superior efficacy compared to existing treatments. The KOL event aims to provide further insights into the regulatory pathway for chronic suppression.
Aligos Therapeutics (Nasdaq: ALGS) announced positive data at the EASL Congress 2024, highlighting the antiviral efficacy of ALG-000184 for chronic hepatitis B (CHB). The data showed that 90% of HBeAg-positive patients had sustained HBV DNA suppression after 72 weeks of 300 mg daily oral monotherapy. In HBeAg-negative patients, 100% achieved complete suppression of HBV DNA and RNA after 60 weeks, with no viral breakthroughs reported. The treatment was well tolerated and showed a positive trend in anti-HBe antibody levels. Additionally, preclinical data demonstrated the potential of next-generation siRNAs for metabolic dysfunction-associated steatohepatitis (MASH) and CHB, as well as a novel CAM-A molecule for CHB treatment.
Aligos Therapeutics (Nasdaq: ALGS), a clinical-stage biopharmaceutical company, announced that six of its abstracts have been accepted for presentation at the European Association for the Study of the Liver (EASL) Congress 2024, taking place from June 5-8 in Milan, Italy. The accepted abstracts include findings on their novel therapeutics for liver and viral diseases.
Highlighted abstracts involve the Capsid Assembly Modulator (CAM) ALG-000184, which has shown promising antiviral effects in chronic hepatitis B (CHB) patients. Notably, two abstracts have earned 'Top' recognition for their outstanding contribution: one on second-generation HBV siRNAs demonstrating improved profiles, and another on CAM-A molecules inducing rapid HBsAg reductions in animal models.
The presentations cover both preclinical and clinical research, reflecting Aligos' leadership in addressing unmet medical needs in liver diseases.
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.
Aligos Therapeutics, a clinical stage biopharmaceutical company, reported recent business progress and financial results for the first quarter of 2024. They initiated the Phase 2a HERALD study of their drug candidate ALG-055009 and presented positive data on their other programs at scientific conferences. The company's cash balance remains strong to fund operations until the end of 2025.
Aligos Therapeutics, a clinical stage biopharmaceutical company, will announce its 1st Quarter 2024 financial results on May 7, 2024. The company focuses on developing therapeutics for liver and viral diseases.
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