Multiple ex vivo human skin studies showed deeper repeat-dose rHDfilaggrin distribution and dose-dependent elasticity gains, as Azitra said it continues optimizing ATR-COSF ahead of a planned human study.
Azitra, Inc. said two ex vivo human skin studies produced encouraging results for its ATR-COSF program, a supernatant-based cosmetic formulation containing a recombinant human filaggrin domain derived from engineered S. epidermidis. In one repeat-dose penetration study using fresh healthy human skin explants stimulated with TH2 cytokines to reduce endogenous filaggrin, the company said a 2% lyophilized supernatant hydrogel delivered rHDfilaggrin through the stratum corneum and into the stratum granulosum, with greater amounts seen after additional applications and better concentration in those layers than concentrated supernatant alone. Azitra said safety testing under standardized guidelines found the 2% formulation to be non-irritating and non-corrosive to skin and eyes. In a separate elasticity study using defatted human skin explants, hydrogels containing lyophilized supernatant increased elasticity in a dose-dependent manner 20 hours after application, ranging from a 1.6-fold effect at 0.09% w/w to 4.4-fold at 7.5% w/w. The company said 0.28% w/w restored ex vivo abdominoplasty skin elasticity to values historically observed in healthy skin, while a 0.3% w/w supernatant hydrogel showed about twice the elasticity of placebo-treated skin. Chief Executive Officer Francisco Salva said Azitra plans to continue optimizing formulations and test additional ex vivo wrinkle models as it moves toward a human study designed to translate the findings into visible wrinkle reduction benefits.