Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALG-097558 · 3 trials · 2 indications
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
| Arm | Type | Description |
|---|---|---|
| Subjects with Severe Renal Impairment | EXPERIMENTAL | Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| Subjects with Normal Renal Function | EXPERIMENTAL | Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| Subjects with Mild Renal Impairment (Optional) | EXPERIMENTAL | Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| Subjects with Moderate Renal Impairment (Optional) | EXPERIMENTAL | Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| Subjects with Moderate Hepatic Impairment (Child-Pughs Class B) | EXPERIMENTAL | Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| Subjects with Normal Hepatic Function | EXPERIMENTAL | Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| ALG-097558 | EXPERIMENTAL | Oral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days |
| Placebo | PLACEBO_COMPARATOR | Oral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days |
| ALG-097558 and Midazolam | EXPERIMENTAL | Oral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers |
| ALG-097558, Placebo, and, Itraconazole | EXPERIMENTAL | Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers. |
| ALG-097558 and Carbamazepine | EXPERIMENTAL | Oral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers |
| ALG-097558 Bioavailability | EXPERIMENTAL | Oral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers |
| Name | Type | Description |
|---|---|---|
| ALG-097558 | DRUG | Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets) |
| Placebo | DRUG | single or multiple doses of placebo |
| Midazolam | DRUG | Multiple doses of Midazolam |
| Itraconazole | DRUG | Multiple doses of Itraconazole |
| Carbamazepine | DRUG | Multiple doses of Carbamazepine |
| ALG-097558 in solution formulation | DRUG | ALG-097558 in solution administered in fasted state |
| ALG-097558 in tablet formulation | DRUG | ALG-097558 in tablet administered in fasted and fed state |
Inclusion Criteria for All Subjects: 1. Male and Female between 18 and 75 years old 2. Body Mass Index (BMI) 17.5 to 40.0 kg/m\^2 and a total body weight \>50 kg (110 lb) 3. Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only ...
ALG-097558 is an investigational small molecule being developed for COVID-19. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers and in subjects with hepatic or renal impairment to evaluate its safety, tolerability, and pharmacokinetics.
ALG-097558 is being developed by Aligos Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ALGS. The company is conducting Phase 1 clinical trials of this investigational drug for the treatment of COVID-19.
ALG-097558 is in Phase 1 clinical development. Three Phase 1 studies have been completed, including a first-in-human study in healthy volunteers, a hepatic impairment study, and a renal impairment study. The drug is investigational and has not received FDA approval.
ALG-097558 has been studied in three completed Phase 1 trials. NCT05840952 evaluated safety, tolerability, pharmacokinetics, and drug-drug interactions in 90 healthy volunteers in the United Kingdom. NCT06568861 assessed pharmacokinetics in 16 subjects with hepatic impairment in the United States. NCT06698549 evaluated pharmacokinetics in 12 subjects with renal impairment in the United States.
No, ALG-097558 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for COVID-19. All completed trials have been early-stage studies focused on safety, tolerability, and pharmacokinetics in healthy volunteers and special populations.