Phase 2
N=29
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Cystic Fibrosis · Pseudomonas Aeruginosa · Pseudomonas · Lung Infection · Lung Infection Pseudomonal
Bottom Line
View on ClinicalTrials.gov: NCT04596319 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Jan 2024
Primary outcome: Primary: Incidence and Severity Treatment Emergent Adverse Events (TEAEs) — 1; 1; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AP-PA02 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Armata Pharmaceuticals, Inc.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity Treatment Emergent Adverse Events (TEAEs) |
1; 1; 1; 0; 5; 2 | — |
Summary
Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered by inhalation in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection.
Eligibility Criteria
Key Inclusion Criteria
- ≥ 18 years old
- Body mass index (BMI) of ≥ 18 kg/m2
- Documented diagnosis of CF
- Evidence of chronic pulmonary Pseudomonas aeruginosa infection
- Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)
- For SAD: FEV1 ≥ 60% of predicted normal [per Global Lung Function Initiative (GLI) standards] at Screening
- For MAD: FEV1 ≥ 40% of predicted normal [per Global Lung Function Initiative (GLI) standards] at Screening
- Adequate renal function
Key Exclusion Criteria
- Recent significant weight loss
- Abnormal vital signs at Screening
- History of prolonged QT syndrome
- Use of supplemental oxygen during the day at rest
- Abnormal liver function tests greater than 3X the upper limit of normal (ULN)
- Recent oral or IV antibiotics received for acute pulmonary exacerbation. Inhaled antibiotic use for chronic suppression of P. aeruginosa is acceptable.
- Recent clinically significant infection requiring systemic antimicrobial therapy
- Currently receiving anti-pseudomonal antibiotic treatment for acute sinusitis.
- Currently receiving systemic corticosteroids
- Currently receiving treatment for active infection with nontuberculous mycobacteria (NTM), Staphylococcus aureus, or Burkholderia cepacia complex lung infection
- Currently receiving treatment for aspergillosis or ABPA (allergic bronchopulmonary aspergillosis)
- Initiation of a CFTR potentiator/corrector therapy, such as Trikafta®, less than 90 days prior to Screening
- Acquired or primary immunodeficiency syndromes
- Active pulmonary malignancy (primary or metastatic)
- History of lung transplantation
- Recent hemoptysis
- Female pregnant or breastfeeding
- Heavy smoker
Data sourced from ClinicalTrials.gov (NCT04596319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.