ALG-097558 / Aligos Therap - LARVOL DELTA

Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers (clinicaltrials.gov) - P1 | N=51 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P1 trial • Infectious Disease • Novel Coronavirus Disease

A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558 (clinicaltrials.gov) - P1 | N=90 | Completed | Sponsor: Aligos Therapeutics | Active, not recruiting ➔ Completed | N=144 ➔ 90 | Trial completion date: Nov 2024 ➔ Apr 2024

Enrollment change • Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Potent, Pan-Coronavirus Antiviral Activity of the Novel 3CLpro Inhibitor ALG-097558 (CROI 2025) - "Against Omicron subvariants, ALG-097558 is 3- to 9-fold more active than nirmatrelvir (the 3CLpro inhibitor in Paxlovid™). Other 3CLpro inhibitors in clinical development such as ensitrelvir and ibuzatrelvir demonstrated greatly reduced antiviral activity against α-CoVs...Conclusions ALG-097558 demonstrates potent, pan-coronaviral activity in preclinical experiments and is uniquely positioned as a treatment option for SARS-CoV-2 infection and potential future coronavirus pandemics. After having demonstrated a favorable clinical safety and PK profile in Phase I, including ritonavir-free dosing, ALG-097558 warrants further evaluation in patients with COVID-19."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "'That future looks bright as we move ALG-000184 closer towards a Phase 2 clinical study, which is expected to begin in mid-2025.'...ALG-097558...The NIAID is also sponsoring a drug-drug interaction and relative bioavailability study in healthy volunteers that is expected to start dosing in the second quarter of 2025."

New P2 trial • New trial • Hepatitis B • Infectious Disease • Novel Coronavirus Disease

ALG-097558-703: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Renal Impairment and in Healthy Subjects with Normal Renal Function (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Aligos Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Renal Disease

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Hepatic Impairment and in Healthy Subjects with Normal Hepatic Function (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Aligos Therapeutics | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2024 ➔ Jan 2025 | Trial primary completion date: Jan 2025 ➔ Apr 2025

Enrollment open • Trial initiation date • Trial primary completion date • Hepatology • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Renal Impairment and in Healthy Subjects with Normal Renal Function (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Aligos Therapeutics

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Renal Disease

A Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558 (clinicaltrials.gov) - P1 | N=144 | Active, not recruiting | Sponsor: Aligos Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Nov 2024

Enrollment closed • Trial completion date • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Aligos Therapeutics

New P1 trial • Hepatology • Infectious Disease • Novel Coronavirus Disease

Safety and pharmacokinetics of single and multiple ascending doses of ALG-097558, a pan-coronavirus protease inhibitor, in healthy volunteers (ECCMID 2024) - No abstract available

Clinical • PK/PD data • Infectious Disease • Novel Coronavirus Disease

A Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558 (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Aligos Therapeutics | Trial completion date: Mar 2024 ➔ Jul 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

On the origins of SARS-CoV-2 main protease inhibitors. (PubMed, RSC Med Chem) - "In less than 3 years of research, 4 inhibitors of SARS-CoV-2-M have actually been authorized for COVID-19 treatment (nirmatrelvir, ensitrelvir, leritrelvir and simnotrelvir) and more such as EDP-235, FB-2001 and STI-1558/Olgotrelvir or five undisclosed compounds (CDI-988, ASC11, ALG-097558, QLS1128 and H-10517) are undergoing clinical trials. Since many series of covalent SARS-CoV-2-M inhibitors owe some of their origins to previous work on other proteases, we first provided a description of various inhibitors of cysteine-bearing human caspase-1 or cathepsin K, as well as inhibitors of serine proteases such as human dipeptidyl peptidase-4 or the hepatitis C protein complex NS3/4A. This is then followed by a description of the results of the approaches adopted (repurposing, structure-based and high throughput screening) to discover coronavirus main protease inhibitors."

Journal • Review • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CASP1 • CTSK • SPECC1

A Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558 (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Aligos Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

Preclinical Antiviral Profile of ALG-097558, a Novel Pan-Coronavirus 3CL Protease Inhibitor (ISIRV-AVG 2023) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease

A Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558 (clinicaltrials.gov) - P1 | N=144 | Not yet recruiting | Sponsor: Aligos Therapeutics

New P1 trial • Infectious Disease • Novel Coronavirus Disease