ALG-097558 for Coronavirus

No longer recruiting at 1 trial location

Overseen By Jen Rito

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aligos Therapeutics

Disqualifiers: Cardiac disease, Drug abuse, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALG-097558 for individuals with moderate hepatic impairment and those without, to observe how their bodies process the drug. The researchers aim to understand how liver health affects the drug's behavior in the body. It suits adults with stable liver problems due to liver disease and those with normal liver function. Participants must not have significant heart issues or a history of drug abuse. The study involves taking the medication twice a day for six days. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants with impaired liver function should have stable medications for at least 28 days before the trial, suggesting you may need to continue your current medications if they are stable.

Is there any evidence suggesting that ALG-097558 is likely to be safe for humans?

An earlier study tested ALG-097558 for 7 days, and participants tolerated it well. The treatment worked without requiring additional drugs to enhance its effects, indicating it is gentle on the body.

Reports of serious side effects are few. Most participants did not experience severe negative reactions, suggesting that while some might have mild side effects, the treatment appears safe for most.

So far, ALG-097558 has demonstrated positive safety results in early studies, making it a strong candidate for further testing in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ALG-097558 because it offers a potentially new approach to treating coronavirus. Unlike standard treatments like antivirals such as Remdesivir, ALG-097558 is being examined for its effectiveness in individuals with varying liver functions, including those with moderate hepatic impairment. This focus on hepatic function is significant because it could lead to a broader use of the treatment across different patient populations. Additionally, ALG-097558 promises a quicker treatment timeline, with just six days of dosing, which could mean faster recovery times compared to current therapies.

What evidence suggests that ALG-097558 could be an effective treatment for coronavirus?

Research has shown that ALG-097558 works well against coronaviruses in lab tests. It targets the 3CLpro enzyme, which the virus needs to multiply. This makes ALG-097558 a promising option for treating COVID-19 and other coronavirus infections. In this trial, participants with either moderate hepatic impairment or normal hepatic function will receive ALG-097558. Studies have found that ALG-097558 is more effective against some coronaviruses than other similar drugs being tested. Early results are encouraging and suggest ALG-097558 could be a useful tool in fighting COVID-19. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with moderate liver problems (hepatic impairment) and healthy adults with normal liver function. Participants should match in age, weight, and possibly gender. It's not clear what specific conditions exclude someone from this trial since the exclusion criteria are not provided.

Inclusion Criteria

Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria

My liver functions normally.

I am not able to have children or will use effective birth control.

Exclusion Criteria

Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up

I have a history of heart rhythm problems or risk factors for severe arrhythmias.

Bilirubin (total, direct) >1.2× upper limit of normal (ULN) (unless Gilbert's is suspected)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral doses of 200 mg ALG-097558 twice daily for 6 days

1 week

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ALG-097558

Trial Overview The study is testing ALG-097558, a drug given orally twice daily to see how different levels of liver health affect its presence in the blood over time. This non-randomized study involves both people with moderate liver issues and those without any.

How Is the Trial Designed?

Group I: Subjects with Normal Hepatic Function Experimental Treatment 1 Intervention

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.

Group II: Subjects with Moderate Hepatic Impairment (Child-Pughs Class B) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Aligos Therapeutics

Lead Sponsor

Trials

11

Recruited

960+

Founded

2018

Headquarters

South San Francisco, United States

Known For

Liver & Viral Therapies

Top Products

ALG-000184, ALG-055009, ALG-097558

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

In a phase 3 trial involving 1121 adults, AZD7442 (tixagevimab/cilgavimab) did not meet the primary endpoint of significantly preventing symptomatic COVID-19 compared to placebo, with only a 33.3% relative risk reduction observed.

However, among participants who were SARS-CoV-2 RT-PCR-negative or had missing results at baseline, AZD7442 showed a promising 73.2% reduction in symptomatic COVID-19, suggesting its potential effectiveness in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AZD7442 (Tixagevimab/Cilgavimab) for Post-Exposure Prophylaxis of Symptomatic Coronavirus Disease 2019. Levin, MJ., Ustianowski, A., Thomas, S., et al.[2023]

The human antibody 76E1, isolated from a COVID-19 survivor, shows broad neutralizing activity against various coronaviruses, including SARS-CoV-2 variants, indicating its potential as a therapeutic agent.

76E1 targets a unique epitope on the spike protein of coronaviruses, which is crucial for viral entry, suggesting that it could inform the development of future vaccines and antiviral treatments against a wide range of coronaviruses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neutralization mechanism of a human antibody with pan-coronavirus reactivity including SARS-CoV-2. Sun, X., Yi, C., Zhu, Y., et al.[2022]

AZD7442, a combination of two monoclonal antibodies, effectively prevents SARS-CoV-2 infection and accelerates virus clearance in nonhuman primates, indicating its potential for both prevention and treatment of COVID-19.

In a phase 1 study with healthy participants, a single 300-mg injection of AZD7442 resulted in neutralizing antibody levels significantly higher than those found in convalescent serum, providing protection for at least 9 months, suggesting it could be a long-lasting option for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans. Loo, YM., McTamney, PM., Arends, RH., et al.[2023]

A new derivative of aloperine, identified as Compound 5, has shown strong antiviral activity against SARS-CoV-2, with an IC50 of 0.5 µM, making it the most potent variant tested against the virus.

Compound 5 effectively inhibits the entry of SARS-CoV-2 into host cells before the virus can fuse with the cell membrane, indicating its potential as a therapeutic agent against multiple variants, including Delta and Omicron.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quinolizidines as Novel SARS-CoV-2 Entry Inhibitors. Huang, L., Zhu, L., Xie, H., et al.[2023]

Tixagevimab/cilgavimab (TGM/CGM) monoclonal antibodies showed promising efficacy in preventing COVID-19 in high-risk patients, with lower rates of hospitalization (0.54% vs. 1.2%) and severe disease compared to no treatment.

The study analyzed data from 27,932 patients, indicating that TGM/CGM treatment resulted in significantly lower RT-PCR positivity rates (2.1% vs. 5.8%) and better clinical outcomes, although more randomized controlled trials are needed to further confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tixagevimab/Cilgavimab to Prevent COVID-19 (Pre-Exposure Prophylaxis): A Systematic Review and Meta-Analysis. Alhumaid, S., Al Mutair, A., Alali, J., et al.[2023]

Citations

1. aligos.com aligos.com/wp-content/uploads/2023/05/ALG-097558-ISIRV-AVH-oral-final.pdf

Preclinical Antiviral Profile of ALG-097558, a Novel Pan- ... ALG-097558 demonstrates pan-coronavirus activity in cell-based assays. Virus. Variant. EC50 (μM). ALG-097558. Nirmatrelvir. Ensitrelvir. Pomotrelvir. SARS-CoV-2.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06568861?term=AREA%5BConditionSearch%5D(covid-19)%20AND%20AREA%5BBasicSearch%5D(plasma)%20AND%20AREA%5BOverallStatus%5D(RECRUITING)&rank=5

NCT06568861 | A Study to Evaluate the Pharmacokinetics, ... A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers ...

3. bioworld.com bioworld.com/articles/718315-alg-097558-confirmed-as-an-effective-pan-coronavirus-strategy

ALG-097558 confirmed as an effective pan-coronavirus ... Furthermore, ALG-097558 was significantly more effective against α-CoVs than other 3CLpro inhibitors under clinical evaluation, such as ...

4. agiletrial.net agiletrial.net/agile-trials/agile-trials-cst-9a/

Agile CST-9a - The AGILE Clinical Trial Platform This trial aims to assess whether ALG-097558 may be useful for patients with COVID-19 when given alone or in combination with Remdesivir and if either of these ...

5. withpower.com withpower.com/trial/phase-1-covid-19-8-2024-17e5d

ALG-097558 for Coronavirus · Recruiting Participants for Phase ... ... results at baseline, AZD7442 showed a promising 73.2% reduction in symptomatic COVID-19, suggesting its potential effectiveness in this specific group. NCBI ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05840952

NCT05840952 | A First-in-Human Multi-Part Phase 1 Study ... ... Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558. ClinicalTrials.gov ID NCT05840952.

7. investor.aligos.com investor.aligos.com/news-releases/news-release-details/aligos-therapeutics-presents-positive-clinical-data-escmid-2024

Release Details Data demonstrates a 7-day treatment regimen with the pan-coronavirus protease inhibitor ALG-097558 was well tolerated and does not require ritonavir boosting.

8. clinicaltrial.be clinicaltrial.be/en/details/47779?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

AGILE (Early Phase Platform Trial for COVID-19) - Clinica... Dose limiting toxicities (Safety and Tolerability of ALG-097558 and ALG-097558 plus remdesivir combination - CTCAE v5 Grade ≥3 adverse events) ...