NCT05355207

Study to Evaluate Safety and Activity of TRL1068 in Chronic Rhinosinusitis

Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TRL1068 in Subjects With Acute Exacerbation of Chronic Rhinosinusitis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Trellis Bioscience LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens. This initial study is to assess overall safety and pharmacokinetics (PK) of TRL1068. The goal of the development program is to demonstrate effectiveness of TRL1068 in difficult to treat bacterial infections such as in CRS.

Detailed description

Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with significant morbidity and decreased quality of life. Defects in the epithelial cell barrier, increased exposure to pathogenic and colonized bacteria, and dysregulation of the host immune system are all thought to play prominent roles in disease pathogenesis. Colonization with S. aureus or P. aureus are associated with recalcitrant disease and biofilm formation, making eradication difficult. Distribution of topical solutions in the unoperated sinuses has been observed to be less than 2% of the total irrigation volume, with almost no penetration in the frontal and sphenoid sinuses. For those patients with mucosal edema from infection and chronic inflammation, distribution is probably significantly less when applied topically. Intravenously administered TRL1068 is expected to achieve effective anti-biofilm levels throughout the sinonasal space for several weeks. TRL1068 is a monoclonal human antibody that rapidly eliminates biofilm at very low concentrations, thus making the targeted bacterial pathogens substantially more sensitive to standard of care antibiotic treatment regimen and greatly accelerating clinical improvement and potential for bacterial eradication.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DRUG	TRL1068	A human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2022-05-02
• Last updated: 2023-04-12

Regulatory

• FDA-regulated drug study