Azitra, Inc. has been issued a patent for the company’s engineered bacterial strain discovery platform. The United States Patent and Trademark Office (USPTO) has issued US Patent No. 10,702,558, which includes broad composition of matter claims that are central to the the company’s programs for treating skin diseases, and provide a significant barrier to entry for competitors.

One key allowed claim covered under the patent includes the pharmaceutical composition comprising selected bacterial strains and at least one engineered bacterial strain that produces a therapeutically active protein for treating abnormal human skin conditions.

“We are thrilled that the USPTO has granted such broad claims for Azitra’s first issued patent. This foundational patent was filed at the founding of Azitra, and the broad protection it offers for our skin microbiome platform will be critical as the company continues to advance into the clinic. We are moving forward on a number of key programs and plan to expand our pipeline with additional engineered live biotherapeutic product candidates,” says Travis Whitfill, Co-founder and Executive Director of Advanced Technology of Azitra.

Recently published data demonstrate that growth of skin commensal bacteria Staphylococcus epidermidis can be modified without the need of antibiotics or genetic elements that are related to antibiotic resistance. Azitra’s report was published in mSphere. S.epidermidis is known to enhance skin immunity and protect against skin pathogens; it also has the potential to be used as a delivery system for therapeutic proteins that can be used to treat the underlying cause of skin diseases. Azitra’s auxotrophic strain strategy allows the Company to both select S. epidermidis strains and control its growth on the skin.

In the paper, Azitra scientists and colleagues reported the design of an engineered auxotrophic strain of S. epidermidis that contains deletions of three biosynthetic genes and, as a result, requires exogenously supplied D-alanine for growth. In cultured human skin models in vitro, D-alanine treatment robustly increased the strain’s colonization potential and promoted human beta-defensin 2 expression, an important host epithelial antimicrobial peptide.

The strain described in the paper is the company’s lead product candidate, ATR-04, which is a proprietary, auxotrophic strain of the commensal skin bacterium S. epidermidis that was well tolerated in initial clinical studies. Azitra is developing this live biotherapeutic product candidate as an adjunctive treatment for cancer therapy-associated rash, a debilitating and potentially treatment limiting side effect of many cancer therapies, especially EGFR inhibitors. The company recently received Rare Pediatric Disease Designation for a second program, ATR-12 for Netherton syndrome.