Azitra’s ATR01-616 Cuts TEWL (p<0.001) and Restores Skin Barrier Preclinically
Azitra’s ATR01-616 live biotherapeutic reduced transepidermal water loss (p<0.001) across all doses in pig skin and restored filaggrin-keratin co-localization in reconstructed human epidermis, demonstrating functional skin barrier repair. Peak recombinant filaggrin secretion occurred at 6–8 hours post-application, supporting progression toward IND-enabling studies and first-in-human trials.
1. Preclinical Data
Azitra presented data showing ATR01-616 significantly reduced transepidermal water loss (p<0.001) in an ex vivo pig skin model and restored key structural features in reconstructed human epidermis. Peak secretion of recombinant filaggrin occurred 6–8 hours after application, with barrier function returning near baseline within 20 hours.
2. Mechanism of Action
ATR01-616 uses an engineered Staphylococcus epidermidis auxotroph optimized to secrete recombinant human filaggrin fragments directly into the skin. This targeted delivery enables sustained, localized protein therapy and co-localization with keratin proteins to address the underlying filaggrin deficiency in ichthyosis vulgaris.
3. Clinical Development Plan
Based on these validating preclinical results, Azitra plans to advance ATR01-616 into IND-enabling studies, followed by a first-in-human trial in patients with ichthyosis vulgaris. This progression builds on the company’s broader live biotherapeutic platform, which includes programs for Netherton syndrome and EGFR inhibitor–associated rash.