INNA-051 for Viral Respiratory Infections

(POSITS Trial)

Recruiting at 4 trial locations

Overseen By ENA Respiratory

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: ENA Respiratory Pty Ltd

Disqualifiers: Diabetes, Asthma, Active infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new nasal spray called INNA-051 to determine if it can reduce the severity and duration of viral respiratory infections, such as colds and the flu. The goal is to assess the safety and effectiveness of INNA-051 for individuals frequently exposed to these viruses due to their living or work conditions, such as those in crowded environments or jobs with significant public interaction. Participants will use the spray weekly for either 4 or 12 weeks. Ideal candidates are generally healthy adults who often have close contact with others, such as healthcare workers or teachers. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that INNA-051 is likely to be safe for humans?

Research has shown that INNA-051, administered as a nasal spray, was well-tolerated and safe in earlier studies. These studies aimed to assess participants' responses to the treatment and identify any discomfort or side effects. The treatment enhances the body's natural defenses, improving its ability to combat respiratory viruses. So far, participants have responded well to INNA-051, with no major safety issues reported. For those considering joining a trial, these findings suggest that the treatment is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most treatments for viral respiratory infections, which often rely on antiviral drugs or vaccines, INNA-051 is unique because it targets the body's innate immune system to enhance its natural defenses against viruses. This approach could potentially offer a quicker response to viral threats, as it doesn't depend on identifying a specific virus before taking action. Researchers are excited about INNA-051 because it introduces a novel mechanism of action, which may complement existing antiviral treatments and vaccines, potentially reducing the severity and duration of infections.

What evidence suggests that INNA-051 might be an effective treatment for viral respiratory infections?

Research has shown that INNA-051, a nasal spray, might help prevent viral respiratory infections. Animal studies demonstrated its protective effects against viruses like COVID-19 and the flu. INNA-051 activates parts of the immune system, strengthening the body's defenses against infections. Early results suggest it could reduce the severity or duration of these infections. Although more research is needed to confirm these effects in humans, the initial findings are promising for those at risk of respiratory viruses. Participants in this trial will receive either INNA-051 or a placebo to further evaluate its effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Healthy adults aged 18-45 who may be frequently exposed to respiratory viruses, such as those living in crowded conditions or working in high-exposure jobs like healthcare or education. Participants must not have significant health issues and agree to use effective birth control.

Inclusion Criteria

I am in good health with no major medical or psychiatric conditions.

I am at high risk of viral respiratory infection due to my living or working conditions.

I agree to use effective birth control methods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive INNA-051 or placebo once weekly for 4 weeks in an outpatient setting

4 weeks

4 visits (in-person)

Treatment Part B

Participants receive INNA-051 or placebo once weekly for 12 weeks during the North American respiratory virus season

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INNA-051

Trial Overview

The trial is testing INNA-051, an investigational nasal spray, against a placebo to see if it can prevent or reduce the severity of viral respiratory infections. It involves weekly treatments for either 4 or 12 weeks during peak virus season.

How Is the Trial Designed?

Group I: INNA-051 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

ENA Respiratory Pty Ltd

Lead Sponsor

Trials

2

Recruited

120+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07222670

A Study Assessing Safety, Tolerability, and Efficacy of INNA ...

The purpose of this trial is to assess the safety of the investigational agent INNA-051, given intranasally, and its potential effectiveness in ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0166354224002742

Discovery and development of INNA-051, a TLR2/6 agonist ...

Based on the data from in vivo animal models, INNA-051 offers effective prophylaxis against multiple respiratory viruses, including SARS-CoV-2, influenza, and ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39733845/

Discovery and development of INNA-051, a TLR2/6 agonist ...

INNA-051, a TLR2/6 agonist, is in development as an intranasal innate immune enhancer for prophylactic treatment in individuals at risk of complications.

4.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/inna-051-antiviral-phase-2-study-respiratory-disease-breakthrough/

Inna-051 Antiviral Phase 2 Study: Respiratory Disease ...

The study, led by Dr. Justin Ortiz, will evaluate the safety, tolerability, and efficacy of the nasal powder in preventing viral respiratory infections in at- ...

5.

enarespiratory.com

enarespiratory.com/new-data-from-an-influenza-challenge-study-further-support-the-prophylactic-potential-of-inna-051-to-accelerate-viral-clearance/

New Data From an Influenza Challenge Study Further ...

In preclinical studies, INNA-051 and close analogues were shown to be effective against multiple respiratory viruses, including SARS-CoV-2, ...

6.

anzctr.org.au

anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12624000635561

ANZCTR - Registration

INNA-051 dry powder safety and tolerability study. Query! Scientific title. A randomised, double blind, placebo-controlled study to assess the safety ...

7.

enarespiratory.com

enarespiratory.com/ena-respiratory-publishes-review-of-development-of-novel-intranasal-antiviral-host-defense-immune-enhancer-inna-051-in-antiviral-research/

ENA Respiratory Publishes Review of Development ...

INNA-051 is a host defence immune enhancer which locally primes and boosts the body's innate immune response – the natural first line of defence.