Azitra Presents Data Showing Tolerability of its Lead Product Candidate ATR-04

FARMINGTON, CT, USA I October 08, 2019 I Azitra, Inc., a clinical-stage medical dermatology company addressing serious skin conditions by harnessing the microbiome, today presented data on its lead product candidate ATR-04. The results of this cosmetic study showed a single application of ATR-04, a proprietary strain of the commensal skin bacterium Staphylococcus epidermidis, is able to colonize the skin on a dose-dependent basis without causing skin irritation or disrupting the normal resident S. epidermidis population. Company scientists presented the study results at the 2020 Keystone Symposia Conference -- Microbiome: Therapeutic Implications in Killarney, Ireland.

The study was a single-center, prospective, double-blind, three cohort cosmetic study to assess the tolerability and changes in skin microbiome with three ascending doses of ATR-04 in normal, healthy subjects. The objectives of the study were (1) tolerability and (2) pharmacokinetics of three different doses of ATR-04 vs. placebo. Seven subjects were enrolled in each cohort for a total of 21 subjects. No treatment-related events (0/21 subjects) were observed. There was a dose-dependent colonization of ATR-04, and its persistence decayed over time. The presence of ATR-04 did not affect the resident population of S epidermidis.

Mark Sampson, Ph.D., Chief Scientific Officer of Azitra said, “The results of this study showed ATR-04 to be well-tolerated by healthy volunteers with no detectable skin irritation up to one week post application. ATR-04 was applied topically to the skin as an ointment. Additionally, the presence of ATR-04 did not affect the resident skin population of wild-type S. epidermidis.

“This study with ATR-04 was conducted as a cosmetic product. Since then, the Company has re-positioned ATR-04 as a Live Biotherapeutic Product. We plan to conduct clinical testing in 2020 to assess the therapeutic potential of ATR-04 as an adjunctive treatment for Cancer Therapy-Associated Rash (CTAR),” said Richard Andrews, President and Chief Executive Officer of Azitra.

CTAR is a debilitating and potentially treatment limiting side-effect of many cancer therapies and in particular EGFR inhibitor therapy. Such drugs are frequently used in the treatment of cancers of the head and neck, pancreas, breast, colon, and non-small cell lung cancers.

About Azitra

Azitra, Inc. is a clinical-stage medical dermatology company that combines the power of the microbiome with cutting-edge genetic engineering to treat skin disease. The company was founded in 2014 by scientists from Yale University and works with world-leading scientists in dermatology, microbiology, and genetic engineering to advance its pharmaceutical programs to treat cancer therapy associated skin rashes, targeted orphan indications and atopic dermatitis. For more information visit

SOURCE: Azitra

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