# Bacterial Pneumonia Therapeutic Antibody Safety Trial

> **NIH NIH U44** · TRELLIS BIOSCIENCE, INC. · 2024 · $297,917

## Abstract

Abstract
Biofilm is a major contributor to clinical antibiotic resistance, as biofilm-associated (sessile) bacteria show
up to 1000-fold lower sensitivity to antibiotics than free growing (planktonic) forms. The CDC estimates
that 70% of clinically significant antibiotic failure is due to biofilm, including infections associated with
implants, catheters, and tissue adhesions. TRL1068 is a native human monoclonal antibody (mAb) that is
highly effective for disrupting biofilm and thereby enhancing the bactericidal activity of conventional
antibiotics. The antibody target is conserved across both Gram positive and negative bacteria species. With
prior SBIR funding, we demonstrated efficacy in five rodent models. With CARB-X funding, we initiated clinical
development for patients with a prosthetic joint infection (PJI): TRL1068-101 (ClinicalTrials.gov
NCT04763759). Standard of care for such patients includes replacement of the infected implant with an
antibiotic eluting spacer for 8 weeks followed by a second surgery to implant a fresh prosthesis. A planned
interim analysis demonstrated positive safety data, and established that the antibody penetrates into the
synovial space. The bacterial burden on the explanted prosthesis was quantified following a standardized
sonication method from the Mayo Clinic in a standardized volume of Ringer solution. After 7 days of
treatment with TRL1068, 6 of 8 patients (75%) had a bacterial biofilm burden below 100 CFU/mL sonication
fluid, and for 2 of them the adherent bacteria were below the limit of detection. The reduction and removal of
biofilm in these eight PJI patients compares favorably to historical data (n=60) for which implants from only
15% of PJI patients were below 100 CFU/mL sonication fluid. In one of the animal models above, TRL1068 was
administered directly to the respiratory system and was shown to be effective for bacterial pneumonia. Here,
we propose to conduct a Phase 1 safety trial in healthy adult volunteers for TRL1068 formulated for
nebulized delivery as an inhaled therapeutic to treat bronchial infections. We have previously developed an
inhaled formulation for our influenza therapeutic mAb program (near-IND). Direct administration of TRL1068
to the airways should provide superior efficacy at a substantially reduced dose.

## Key facts

- **NIH application ID:** 10918359
- **Project number:** 1U44AI183920-01
- **Recipient organization:** TRELLIS BIOSCIENCE, INC.
- **Principal Investigator:** Lawrence Michael Kauvar
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $297,917
- **Award type:** 1
- **Project period:** 2024-07-18 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10918359

## Citation

> US National Institutes of Health, RePORTER application 10918359, Bacterial Pneumonia Therapeutic Antibody Safety Trial (1U44AI183920-01). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10918359. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*