What is the mechanism of action of this treatment?

Common treatments for pneumonia include antibiotics, which target and kill the bacteria causing the infection, and supportive care such as oxygen therapy and fluids. Antibiotics like macrolides, beta-lactams, and fluoroquinolones disrupt bacterial cell wall synthesis, protein synthesis, or DNA replication, leading to bacterial death. Inhaled AP-PA02, a bacteriophage therapy, specifically targets Pseudomonas aeruginosa by infecting and lysing the bacterial cells. This is particularly important for pneumonia patients with chronic Pseudomonas infections, as it offers a targeted approach that can reduce bacterial load and improve outcomes, especially in cases where antibiotic resistance is a concern.

What side effects are associated with this type of intervention?

Common treatments for pneumonia, particularly those targeting Pseudomonas aeruginosa, include inhaled antibiotics like tobramycin and aztreonam lysine. Tobramycin may lead to increased aminoglycoside resistance but typically does not cause nephrotoxicity or ototoxicity at inhaled doses. Aztreonam lysine can cause airway inflammation if not properly formulated. Bacteriophage therapies, such as inhaled AP-PA02, are still under investigation but are generally considered to have fewer side effects compared to traditional antibiotics, with potential risks including allergic reactions and bacterial resistance.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of pneumonia, including those targeting Pseudomonas aeruginosa. Notable examples include inhaled tobramycin and inhaled aztreonam lysine, both of which are used for chronic Pseudomonas aeruginosa infections in cystic fibrosis patients. These treatments are similar to the bacteriophage therapy being studied in the trial for inhaled AP-PA02, as they also target Pseudomonas aeruginosa in the lungs. While bacteriophage therapy represents a novel approach, the concept of inhaled treatments for bacterial lung infections has precedent in these FDA-approved antibiotics.

What other types of research exist?

Promising novel alternatives to Inhaled AP-PA02 for treating pneumonia caused by Pseudomonas aeruginosa include: 1) Inhaled antibiotics such as tobramycin and colistimethate sodium, which have shown efficacy in chronic pulmonary infections. 2) Combination therapies involving inhaled antibiotics and oral agents like azithromycin, which have demonstrated benefits in weight gain and delaying pulmonary exacerbations. 3) Investigational therapies like inhaled mucolytics and oscillatory positive expiratory pressure (OPEP) devices, which aid in sputum clearance and improve lung function. These alternatives are supported by clinical evidence and ongoing research in pulmonary infection management.

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Virus Therapy

Inhaled Phage Therapy for Bronchiectasis (Tailwind Trial)

Phase 2

Waitlist Available

Research Sponsored by Armata Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests an inhaled treatment called AP-PA02 for patients with a persistent lung infection caused by Pseudomonas aeruginosa. The treatment uses tiny viruses to kill the harmful bacteria in the lungs. The study aims to see if this new approach is safe and effective.

Who is the study for?

Adults over 18 with non-cystic fibrosis bronchiectasis and chronic lung infection caused by Pseudomonas aeruginosa. Participants must have a BMI of ≥ 18 kg/m2, evidence of bronchiectasis on CT scan, and be able to produce sputum samples. Exclusions include abnormal vital signs, immune deficiencies, significant weight loss, certain heart conditions, history of lung transplant or cystic fibrosis, recent changes in respiratory treatments or active infections elsewhere.

What is being tested?

The trial is testing AP-PA02—an inhaled treatment—against a placebo for safety and effectiveness in treating chronic pulmonary Pseudomonas aeruginosa infection. This phase 2 study randomly assigns participants to receive either the real drug or a placebo without them knowing which one they're getting.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include irritation at the site of inhalation, coughing fits during administration, potential allergic reactions to components within AP-PA02 therapy or general discomfort associated with inhaling medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 1 & 2 trial • 29 Patients • NCT04596319

33%

vaccination complication

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 SAD

MAD Placebo

Cohort 3 MAD

SAD Placebo

Cohort 2 SAD

Cohort 4 MAD

Amendment 5 MAD

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AP-PA02Experimental Treatment1 Intervention

Anti-pseudomonal bacteriophage

Group II: PlaceboPlacebo Group1 Intervention

Inactive isotonic solution

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AP-PA02

2020

Completed Phase 2

~80

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pneumonia include antibiotics, which target and kill the bacteria causing the infection, and supportive care such as oxygen therapy and fluids. Antibiotics like macrolides, beta-lactams, and fluoroquinolones disrupt bacterial cell wall synthesis, protein synthesis, or DNA replication, leading to bacterial death. Inhaled AP-PA02, a bacteriophage therapy, specifically targets Pseudomonas aeruginosa by infecting and lysing the bacterial cells. This is particularly important for pneumonia patients with chronic Pseudomonas infections, as it offers a targeted approach that can reduce bacterial load and improve outcomes, especially in cases where antibiotic resistance is a concern.

Morpholino oligomers tested in vitro, in biofilm and in vivo against multidrug-resistant Klebsiella pneumoniae.

Find a Location

Who is running the clinical trial?

Armata Pharmaceuticals, Inc.Lead Sponsor

12 Previous Clinical Trials

485 Total Patients Enrolled

Mina Pastagia, MDStudy DirectorArmata Pharmaceuticals, Inc.

Media Library

AP-PA02 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05616221 — Phase 2

Pneumonia Research Study Groups: AP-PA02, Placebo

Pneumonia Clinical Trial 2023: AP-PA02 Highlights & Side Effects. Trial Name: NCT05616221 — Phase 2

AP-PA02 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05616221 — Phase 2

~17 spots leftby Oct 2025

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