ALG-097558 for Coronavirus

Overseen By Steven Hull

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Amphetamines, Barbiturates, Narcotics, others

Disqualifiers: Cardiac disease, Drug allergy, Viral infections, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the experimental drug ALG-097558 interacts with other medications and its absorption in the body. The researchers aim to determine if ALG-097558 affects or is affected by other drugs and how food might alter its absorption. The study seeks healthy volunteers who are non-smokers and free from significant health issues. As a Phase 1 trial, this research focuses on understanding how the treatment works 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?

Yes, participants must stop taking any medications, vitamins, and herbal supplements at least one week before the study, except for contraceptives and limited doses of ibuprofen or acetaminophen.

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

Research has shown that ALG-097558 has been tested in studies with healthy volunteers. Results suggest that this drug is generally well-tolerated over a 7-day treatment period. No reports have indicated the need for ritonavir, a medication often used to enhance antiviral treatments, which suggests a good safety profile. While specific side effects were not mentioned, the absence of additional medication to manage the drug's effects is a positive sign. As an early-phase study, it is designed to closely monitor safety and any side effects, providing extra reassurance. Each person's experience can differ, so discussing participation with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about ALG-097558 because it offers a potential new way to tackle coronavirus infections. While most treatments focus on reducing symptoms or acting as antivirals like remdesivir, ALG-097558 introduces a novel mechanism that might enhance its effectiveness. This treatment is administered in a spray-dried dispersion tablet form, which could improve absorption and efficacy compared to conventional tablets. Such innovative drug delivery methods might lead to faster and more reliable results, making ALG-097558 a promising candidate in the fight against coronavirus.

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

Research has shown that ALG-097558, which participants in this trial will receive in various formulations and dosages, could be a promising treatment for coronavirus. It demonstrated high effectiveness in lab tests against different coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. ALG-097558 blocks a key enzyme the virus needs to multiply, making it effective against various coronavirus variants. In studies, ALG-097558 proved more effective against certain coronaviruses than some other treatments under investigation. These early results suggest that ALG-097558 could be a strong option for fighting coronavirus infections. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

Healthy adults aged 18-65, nonsmokers for at least 3 months, with a BMI of 18.0 to 32.0 kg/m^2 can join this trial. Women must be postmenopausal, permanently sterile or using effective birth control; men must use condoms during the study and not donate sperm for 90 days after.

Inclusion Criteria

I can read and agree to follow the study rules and attend all visits.

I am a woman who is either postmenopausal, cannot have children, or use reliable birth control.

I am unable to have children due to a permanent procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A - Drug-Drug Interaction Evaluation

Evaluate the effect of itraconazole on the pharmacokinetics of ALG-097558 and its metabolite

10 days

Multiple visits for dosing and monitoring

Part B - Drug-Drug Interaction Evaluation

Evaluate the effect of ALG-097558 on the pharmacokinetics of dabigatran

5 days

Multiple visits for dosing and monitoring

Part C - Bioavailability and Food Effect Study

Study the bioavailability of ALG-097558 and the effect of food on its pharmacokinetics

7 days

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ALG-097558

Trial Overview

The trial is testing ALG-097558's interactions with other drugs (itraconazole and dabigatran) and how food affects its absorption in new tablet forms. It's divided into three parts: drug interaction risks, bioavailability of different formulations, and the impact of food intake.

How Is the Trial Designed?

Group I: Part C Sequence 3 Arm Experimental Treatment 1 Intervention

A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)

Group II: Part C Sequence 2 Arm Experimental Treatment 1 Intervention

A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5)

Group III: Part C Sequence 1 Arm Experimental Treatment 1 Intervention

A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5)

Group IV: Part B Arm Experimental Treatment 2 Interventions

A single oral dose of 75 mg of dabigatran will be administered on Day 1, in a fasted stated, followed by a washout period of at least 3 days. Participants will then receive multiple oral doses of 600 mg of ALG-097558 Q12H as a spray-dried dispersion (SDD) tablet on Days 4-5, in a fasted state. A single oral dose of 75 mg of dabigatran will be given on Day 5, in a fasted state. (N=24)

Group V: Part A Arm Experimental Treatment 3 Interventions

A single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12)

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40586480/

Discovery and Preclinical Profile of ALG-097558, a Pan- ...

We report the discovery of an orally available, reversible covalent inhibitor of the SARS-CoV-2 main protease that is also highly active across other human ...

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04746183

AGILE (Early Phase Platform Trial for COVID-19)

Candidate-Specific Trial 9 (CST-9a): A multicentre, adaptive Phase II Platform trial to evaluate the safety, efficacy and virological response of ALG-097558 as ...

5.

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 ...

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.