Bench2Bedside:
Tell our readers a bit about Azitra and what is unique about your approach.

Francisco Salva:
Azitra is working on a truly unique way to treat challenging skin conditions—precision medicine targeted to dermatologic disorders. Azitra’s therapies are topically delivered, so they would be rubbed onto affected areas—delivering protein or gene therapies via topical solutions.

Our technologies are powered by microbial and genetic engineering, utilizing our own native skin microbiome. We’ve built a library of microbial bacteria strains commonly found on normal people and characterized them to identify specific strains to deliver special proteins that may be missing or aberrantly made in the skin.

So, we’re leveraging the billions of microbial bacteria that naturally live on or in our skin, which have the ability to get past the outer protective layer of the skin called the stratum corneum.

To review, our treatments are topically applied, rubbed onto the skin. These are living treatments, and the microbes are able to live, to thrive, underneath the stratum corneum, where they grow, multiply and colonize, while delivering specific therapies into the skin. By genetically engineering specific strains of these microbes, we’re able to synthetically make proteins that are missing in the patient’s skin and deliver them to the deeper layers of the epidermis. We feel our platform is unique as we genetically engineer specific strains of microbes, which colonize in the skin, to create in situ factories that make and deliver the protein, peptide or therapeutic molecule.

Bench2Bedside:
Tell us about the medical need you hope to address with this novel approach

Francisco Salva:
Our lead candidate, ATR-12 targets a very rare, orphan disease known as Netherton Syndrome. This is an autosomal recessive disease estimated to affect approximately one in every 200,000, but its prevalence may be underestimated due to misdiagnosis. It is a chronic disease of the skin, characterized by severe inflammation, pruritus, scaling, red, and dehydrated skin. Infants born with Netherton syndrome may suffer from a failure to thrive, and it has been reported that approximately one in ten infants with Netherton syndrome die in their first year of life. Those that survive face a lifetime of skin disease challenges including red, scaly skin, hair defects and an ongoing higher than normal risk for infection and allergy. There is no known cure for Netherton syndrome, and treatment options are limited.

We’re also advancing ATR-04 for EGFR inhibitor (“EGFRi”) associated rash, which is caused by the suppression of skin immunity by EGFRis leading to inflammation and often elevated levels of a pro-inflammatory cytokine called IL-36γ and an infectious bacterial species called Staphylococcus aureus.

Targeted cancer therapies like EGFRis have led to significant treatment advances for patients with a variety of cancers, but they are also associated with unique dermatologic toxicities that may hamper treatment efforts and cause significant physical and psychological discomfort for patients. In many cases, the rash leads to severe quality of life issues and can even lead to the interruption or cessation of the EGFRi treatment. There are approximately 150,000 patients suffering from EGFRi rash in the United States.

Bench2Bedside:
What’s the latest news and what can we expect in in 2025 from Azitra?

Francisco Salva:
For ATR-12 targeting Netherton Syndrome, we have a proof of concept, Phase 1b trial enrolling adults, and we’re expecting to report early safety and tolerability data in the first half of 2025. Notably, we have received Rare Pediatric Disease Designation from the FDA for ATR-12.

We’re also very actively progressing ATR-04, which has received Fast Track designation from the FDA. We plan to initiate a Phase 1/2 clinical study in patients with EGFRi rash in the first half of 2025.