Azitra, Inc., a company developing microbiome-based cosmetics and therapeutics to treat skin diseases and conditions, announced that enrollment has been completed for the first human safety study of AZT-04. AZT-04 is the Company’s lead product candidate and is in development for cosmetic use and select therapeutic indications.
A balanced microbiome is critical to maintaining natural and healthy looking skin. AZT-04 is a formulated topical product that contains a proprietary strain of Staphyloccocus epidermidis (SE). SE is a natural commensal organism that lives on the skin of humans that has demonstrated the potential to improve skin appearance. The development of AZT-04 is based on extensive research supported by a large number of scientific publications showing the promise of SE to improve the appearance of the skin.
“There is growing scientific evidence that applying a SE commensal such as AZT-04 to the skin may have promise in remediation of different skin conditions,”
said Julia Oh, Ph.D., Assistant Professor at The Jackson Laboratory.
“This study is an important first step toward validating this concept, and gaining a better understanding of how AZT-04 performs.”
The Jackson Laboratory and Azitra have a research collaboration, and Dr. Oh is a scientific advisor to the company.
Azitra’s first human study of AZT-04 is a cosmetic study and it will examine the safety of three doses as well as evaluate changes in the skin microbiome after topical application of the natural microbiological agent. This trial will be conducted as a double-blind, placebo-controlled study. The NCT number assigned by clinicaltrials.gov for this study is NCT03820076. In future studies, Azitra also plans to assess the potential of AZT-04 to prevent and treat rashes associated with cancer therapy, such as EGFR inhibitor-associated rashes.
“As evidenced by the recent article in Science, there is growing interest in role SE plays in sustaining a healthy skin microbiome, and in the potential of leveraging the organism to improve skin appearance and address skin disorders and diseases,”
said Richard Andrews, President and Chief Executive Officer of Azitra.
“The development pathway of AZT-04 for cosmetic use is relatively straightforward and we expect this program to progress rapidly. We plan to conduct additional studies for the product later this year for both cosmetic use–addressing skin appearance–and as a therapeutic for the treatment and prevention of rash associated with cancer therapy.”