Drug intelligence / Profile preview

AUP-16

Development stage
Phase 2
Lead developer
Aurealis Therapeutics
Modality
Cell Therapies, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Gene Therapies
Administration
Topical
01

Overview

AUP-16 is a first-in-class, genetically engineered probiotic bacterium (Lactococcus cremoris or Lactococcus lactis) developed as a topical cell and gene therapy for chronic wounds. The bacterium is modified to produce and release three human therapeutic proteins—fibroblast growth factor 2 (FGF-2), interleukin 4 (IL-4), and colony stimulating factor 1 (CSF-1)—directly at the wound site. These proteins act synergistically to modulate the immune microenvironment by promoting macrophage conversion from pro-inflammatory M1 to anti-inflammatory M2 phenotype, increasing fibroblast proliferation, inducing angiogenesis, supporting granulation tissue formation, and accelerating reepithelialization. This multi-target approach aims to halt chronic inflammation and promote tissue regeneration in wounds that are otherwise difficult to heal. The product is applied topically under wound dressings for indications such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers. Developed by Aurealis Therapeutics, with licensing collaboration in Greater China with Xbiome, AUP-16 has reached Phase II clinical trials for diabetic foot ulcer[1][2][3][4][5][6][7][8].

Other names
AUP-16 (AUP1602-C)
02

Targets

IL4R (Interleukin-4 receptor alpha subunit)HS (Heparan sulfate)CSF1R (Macrophage colony-stimulating factor receptor)FGFR (FGFR family)

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