Azitra is presenting new preclinical results for ATR-COSF, a topical recombinant filaggrin product being developed for cosmetic skincare, and says it expects initial results from a first-in-human study by the end of 2026. The company also outlined an expansion of its ongoing ATR-04 study, which is testing a treatment for skin rashes associated with cancer drugs.
The updates were presented by co-founder and Chief Operating Officer Travis Whitfill at the BIO-Europe conference on November 10.
ATR-COSF results and next steps
- In an ex vivo human torso-skin model, a single application of ATR-COSF was associated with a 56% reduction in wrinkles from baseline. Ex vivo models use human tissue outside the body; these results are not evidence of cosmetic benefit in people.
- In separate ex vivo models, ATR-COSF improved elasticity and reduced wrinkle depth compared with a vehicle control after 48 hours. The company said the 4% formulation improved elasticity in one of the models.
- Azitra plans to take ATR-COSF into a first-in-human study and anticipates initial results by year-end. The announcement did not provide study design or enrollment details.
- The program is intended to use filaggrin domains in a topical product to reduce the appearance of fine lines and wrinkles. Azitra said the work applies its microbial-engineering platform to skincare as well as to its dermatology programs.
ATR-04 study expansion
- Azitra’s Phase 1/2 trial of ATR-04 is ongoing. The company expanded it in October to include rashes associated with KRAS and MEK inhibitors, in addition to rashes associated with EGFR inhibitors.
- The expanded study also includes people with neurofibromatosis type 1 (NF1) who have rashes associated with MEK inhibitors.
- Azitra estimates that about 220,000 people in the U.S. receive EGFR-inhibitor treatment annually and about 85,000 receive KRAS- or MEK-inhibitor treatment. Those figures describe treatment populations, not the number of patients who develop rashes.
- The company says ATR-04 has received FDA Fast Track designation for cancer-treatment-associated rash. The designation does not establish that the treatment is safe or effective.
What changes for investors
ATR-COSF’s reported results are from laboratory models, with human-study results still pending. ATR-04’s expanded trial broadens the patient groups being studied; it does not represent an approval or a demonstrated benefit in those groups.