Aligos Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which is engaged in in developing therapeutics for chronic liver diseases and viral infections. The firm is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses, as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). The company was founded by Lucinda Quan and Lawrence M. Blatt on February 05, 2018 and is headquartered in South San Francisco, CA.
相关临床试验
16
3 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2018
进行中（未招募）
3
18.8%
已完成
10
62.5%
终止
3
18.8%
暂无批准数据
- The United States Adopted Names Council has approved pevifoscorvir sodium as the nonproprietary name for ALG-000184, marking the first generic name for an Aligos Therapeutics compound. - Pevifoscorvir sodium is a potential best-in-class oral capsid assembly modulator being developed for chronic hepatitis B virus infection treatment. - The drug candidate is currently advancing through Phase 2 B-Supreme study with interim data projected in 2026 and topline data anticipated in 2027. - Phase 1 studies demonstrated that pevifoscorvir sodium was well-tolerated with no safety signals and showed sustained reductions in multiple HBV markers including DNA, RNA, and surface antigen.
- Aligos Therapeutics has begun dosing patients in the Phase 2 B-SUPREME study of ALG-000184, an investigational oral therapy for chronic hepatitis B virus infection. - The randomized, double-blind trial will compare ALG-000184 monotherapy with tenofovir disoproxil fumarate in approximately 200 untreated adult patients over 48 weeks. - Previous Phase 1 trials demonstrated that ALG-000184 was well-tolerated with significant antiviral activity and linear pharmacokinetics. - The study aims to achieve HBV DNA levels below the lower limit of quantitation, with interim data expected in 2026 and topline results in 2027.
- Aligos Therapeutics has appointed Kieron Wesson, PhD as Vice President, Head of Chemistry Manufacturing Controls (CMC), bringing over 20 years of pharmaceutical development experience to the company. - The appointment comes at a strategic time as Aligos prepares to begin its Phase 2 study of ALG-000184 in mid-2025 for liver and viral diseases. - Dr. Wesson previously led CMC operations at Kezar Life Sciences and AN2 Therapeutics, and supported the approval and commercial launches of Kerydin® and Eucrisa® at Anacor Pharmaceuticals. - The hire reinforces Aligos' commitment to advancing its pipeline of therapeutics targeting chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.
- Aligos Therapeutics presented 96-week data showing ALG-000184 achieved significant HBV DNA suppression in both HBeAg-positive and HBeAg-negative patients, positioning it as a potential first-line therapy for chronic hepatitis B. - The Phase 2a HERALD study of ALG-055009 demonstrated robust liver fat reduction in MASH patients, with notable efficacy even in subjects already on GLP-1 agonist therapy, suggesting potential combination treatment approaches. - Both investigational compounds maintained favorable safety profiles while showing best-in-class potential in their respective therapeutic areas, addressing significant unmet needs in liver disease treatment.
• Aligos Therapeutics has secured a $105 million private placement financing led by a life sciences investment firm, strengthening its position to advance ALG-000184 into Phase 2 clinical trials for chronic hepatitis B. • The financing structure includes a combination of common stock shares and warrants, with the transaction expected to close by February 13, 2025. • The funding is projected to extend Aligos' cash runway into the second half of 2026, supporting the company's continued development of liver and viral disease therapeutics.
• Aligos Therapeutics received FDA clearance for its Investigational New Drug (IND) application for ALG-000184, a capsid assembly modulator for chronic hepatitis B (CHB). • A Phase 1 Drug-Drug Interaction (DDI) study will assess the impact of cytochrome P450 inhibitors and inducers on ALG-000184 pharmacokinetics. • Phase 2 enabling activities are underway, with a Phase 2 study filing anticipated in Q1 2025, evaluating ALG-000184 against standard of care in CHB subjects. • ALG-000184 has demonstrated broad antiviral activity, potentially improving outcomes compared to current treatments for chronic hepatitis B.
• Aligos Therapeutics announced positive results from its Phase IIa HERALD trial of ALG-055009 for MASH, demonstrating notable liver fat reduction. • The trial, involving 102 subjects, showed that doses of ALG-055009 led to up to 70% of subjects experiencing a ≥30% relative decrease in liver fat. • ALG-055009 exhibited a favorable tolerability profile with mainly mild to moderate adverse events and significant decreases in atherogenic lipids. • Aligos is currently evaluating options to fund continued development, with plans to complete activities for a Phase IIb study by mid-2025.
