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 ...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
ALG-097558 is an investigational small molecule being developed for the treatment of COVID-19. It is in Phase 1 clinical development and has not been approved for any indication. All clinical work to date has been in healthy adult volunteers rather than in patients with active infection.
ALG-097558 targets the pan-coronavirus protease, an enzyme in the protease class that coronaviruses rely on for viral replication. By acting on this pan-coronavirus target, the compound is designed as a direct-acting antiviral small molecule against COVID-19.
ALG-097558 is being developed by Aligos Therapeutics, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol ALGS. Aligos is the sponsor of the clinical program evaluating the compound in COVID-19.
ALG-097558 is in Phase 1 clinical development. It is an investigational agent and is not FDA approved. Three Phase 1 trials have been completed, and no trials are currently active. The completed studies enrolled a total of 118 participants.
Three completed Phase 1 trials have evaluated ALG-097558. NCT05840952 was a first-in-human study in 90 healthy volunteers in the United Kingdom. NCT06568861 studied participants with hepatic impairment, and NCT06698549 studied participants with renal impairment, both in the United States.
Yes. The ALG-097558 Phase 1 program used randomized, double-blind, controlled designs. The trials enrolled healthy adult volunteers, including participants with hepatic or renal impairment, and assessed pharmacokinetics, safety, tolerability, and drug-drug interaction potential.