Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALG-055009 · 2 trials · 5 indications
Percent relative change from baseline in liver fat content by MRI-PDFF at Week 12
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
| Arm | Type | Description |
|---|---|---|
| ALG-055009 softgel capsule 0.3mg | EXPERIMENTAL | ALG-055009 softgel capsule 0.3mg Daily for 12 weeks |
| ALG-055009 softgel capsule 0.5mg | EXPERIMENTAL | ALG-055009 softgel capsule 0.5mg Daily for 12 weeks |
| ALG-055009 softgel capsule 0.7mg | EXPERIMENTAL | ALG-055009 softgel capsule 0.7mg Daily for 12 weeks |
| ALG-055009 softgel capsule 0.9mg | EXPERIMENTAL | ALG-055009 softgel capsule 0.9mg Daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo softgel capsule Daily for 12 weeks |
| ALG-055009 | EXPERIMENTAL | Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days |
| Name | Type | Description |
|---|---|---|
| ALG-055009 | DRUG | Softgel Capsule |
| Placebo | DRUG | Softgel Capsule |
Key Inclusion Criteria: * Male or female, 18 to 75 years of age * Body mass index (BMI) ≥ 25 kg/m2 * Diagnosis of presumed NASH/MASH with F1-F3 liver fibrosis based on one of the following: * Liver biopsy within 6 months prior to screening showing a NAFLD activity score (NAS) of ≥4 with at least...
ALG-055009 is an investigational small molecule developed by Aligos Therapeutics, Inc. for metabolic liver disease. It is being studied as a treatment for NASH, also called nonalcoholic steatohepatitis or MASH, a fatty liver condition. It is a Phase 2 clinical candidate and has not been approved for any use.
ALG-055009 is being developed to treat NASH, also known as nonalcoholic steatohepatitis or MASH, in non-cirrhotic adults. The Phase 2 HERALD trial enrolled adults with MASH. Because the drug is still investigational, it is not available as a prescribed treatment outside of clinical research.
ALG-055009 targets THR-beta, a thyroid hormone receptor. THR-beta is a nuclear receptor that regulates genes involved in lipid metabolism and liver fat handling, which is the rationale for testing the compound in NASH and hyperlipidemia. ALG-055009 is an orally administered small molecule directed at this receptor.
Aligos Therapeutics, Inc. is developing ALG-055009. The company trades on the Nasdaq under the ticker ALGS. Aligos is a clinical-stage biopharmaceutical company, and ALG-055009 is one of its metabolic disease programs.
ALG-055009 is in Phase 2 clinical development. A Phase 2 study in non-cirrhotic adults with MASH has been completed, and an earlier Phase 1 study in healthy volunteers and subjects with hyperlipidemia has also been completed. The drug remains investigational and has not been approved by the FDA.
ALG-055009 has been studied in two completed trials. The Phase 2 HERALD trial, NCT06342947, randomized 102 non-cirrhotic adults with MASH in the United States. The Phase 1 trial, NCT05090111, enrolled 98 healthy volunteers and subjects with hyperlipidemia in France. Both studies are listed as completed.