Administration of single ascending doses up to 480 mg in healthy volunteers nearly complete
First chronic hepatitis B patient dosed in initial cohort, each of which will be administered 7 subcutaneous doses over 29 days
SOUTH SAN FRANCISCO, CA, USA I January 26, 2022 I Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the first chronic hepatitis B (CHB) patient has been dosed in the multiple ascending dose (MAD) portion of Study ALG-020572-401 (NCT05001022) which is evaluating antisense oligonucleotide (ASO) ALG-020572.
“We are pleased to have initiated the MAD phase of this study in CHB patients,” said Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos. “As with our earlier CHB portfolio drugs entering Phase 1 studies, we plan to evaluate multiple dose levels in patients to determine the risk-benefit profile for ALG-020572 before advancing it into combination studies with other drugs.”
Study ALG-020572-401 is a Phase 1a/1b umbrella study, which is evaluating the safety, pharmacokinetics, and pharmacodynamics (Phase 1b) of the ASO ALG-020572 when given subcutaneously as single doses to healthy volunteers (HVs) or 7 doses over 29 days in CHB patients. Dosing in HVs is nearly complete, with the highest administered dose level being 480 mg. Multiple cohorts are planned in the MAD portion of the study to evaluate the risk-benefit profile of ALG-0202572, including its dose-response effect on viral markers, potentially in multiple CHB subpopulations. The first MAD cohort will evaluate a dose of 210 mg in HBeAg negative, virologically suppressed CHB patients. Results of this and subsequent cohorts will be presented at a future scientific conference.
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 viral infections and liver diseases. Aligos is focused on the 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). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.
Aligos’ CHB portfolio includes an antisense oligonucleotide (ASO), small interfering RNA (siRNA) drug candidates, Class 1 and 2 capsid assembly modulators (CAM-1, CAM-2) and small molecule inhibitors of programmed death ligand 1 (PD-L1). The properties of these candidates indicate that their use in combination could yield potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.
Aligos’ NASH portfolio includes a small molecule thyroid hormone receptor beta (THR-B) agonist, ALG-055009, as well as oligonucleotides with respect to two undisclosed targets that are partnered with Merck.
SOURCE: Aligos Therapeutics
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Administration of single ascending doses up to 480 mg in healthy volunteers nearly complete
First chronic hepatitis B patient dosed in initial cohort, each of which will be administered 7 subcutaneous doses over 29 days
SOUTH SAN FRANCISCO, CA, USA I January 26, 2022 I Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the first chronic hepatitis B (CHB) patient has been dosed in the multiple ascending dose (MAD) portion of Study ALG-020572-401 (NCT05001022) which is evaluating antisense oligonucleotide (ASO) ALG-020572.
“We are pleased to have initiated the MAD phase of this study in CHB patients,” said Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos. “As with our earlier CHB portfolio drugs entering Phase 1 studies, we plan to evaluate multiple dose levels in patients to determine the risk-benefit profile for ALG-020572 before advancing it into combination studies with other drugs.”
Study ALG-020572-401 is a Phase 1a/1b umbrella study, which is evaluating the safety, pharmacokinetics, and pharmacodynamics (Phase 1b) of the ASO ALG-020572 when given subcutaneously as single doses to healthy volunteers (HVs) or 7 doses over 29 days in CHB patients. Dosing in HVs is nearly complete, with the highest administered dose level being 480 mg. Multiple cohorts are planned in the MAD portion of the study to evaluate the risk-benefit profile of ALG-0202572, including its dose-response effect on viral markers, potentially in multiple CHB subpopulations. The first MAD cohort will evaluate a dose of 210 mg in HBeAg negative, virologically suppressed CHB patients. Results of this and subsequent cohorts will be presented at a future scientific conference.
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 viral infections and liver diseases. Aligos is focused on the 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). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.
Aligos’ CHB portfolio includes an antisense oligonucleotide (ASO), small interfering RNA (siRNA) drug candidates, Class 1 and 2 capsid assembly modulators (CAM-1, CAM-2) and small molecule inhibitors of programmed death ligand 1 (PD-L1). The properties of these candidates indicate that their use in combination could yield potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.
Aligos’ NASH portfolio includes a small molecule thyroid hormone receptor beta (THR-B) agonist, ALG-055009, as well as oligonucleotides with respect to two undisclosed targets that are partnered with Merck.
SOURCE: Aligos Therapeutics
Post Views: 313
