Azitra Gets FDA Approval to Study IND for Skin Rash from EGFR Inhibitors

Azitra, Inc., a biopharmaceutical company in the clinical-stage, has received clearance from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND) application. This clearance permits Azitra to conduct a Phase 1/2 clinical trial for ATR-04, a treatment aimed at moderate to severe dermal toxicity caused by EGFR inhibitors (EGFRi). These inhibitors, although effective against certain cancers, often induce significant side effects including severe skin rashes. Current treatments for these rashes typically involve antibiotics, steroids, or other medications, and in severe cases, discontinuation of the cancer therapy becomes necessary. Existing therapies for this skin condition are not approved, placing a high burden on affected cancer patients.

Azitra’s CEO, Francisco Salva, expressed excitement about the IND clearance, emphasizing the high unmet need in this area. He highlighted that the company is eager to expand its clinical pipeline with the development of ATR-04.

ATR-04 is a live biotherapeutic product derived from an isolated strain of Staphylococcus epidermidis. This strain has been engineered to be safer by removing an antibiotic resistance gene and introducing auxotrophy to control its growth. ATR-04 is targeted at treating skin rashes associated with EGFR inhibitors, which are linked to the suppression of skin immunity and subsequent inflammation. This inflammation is often accompanied by elevated levels of IL-36γ and Staphylococcus aureus. In the United States alone, approximately 150,000 patients suffer from skin toxicity induced by EGFR inhibitors, representing a market opportunity exceeding $1 billion.

Earlier in the year, Azitra presented preclinical data on ATR-04 at the Society for Investigative Dermatology (SID) annual meeting and the Annual Meeting for the American Society of Cell and Gene Therapy. The preclinical studies demonstrated significant reductions in IL-36γ and methicillin-resistant Staphylococcus aureus (MRSA).

Following the IND clearance, Azitra plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04. This trial will involve patients undergoing EGFR inhibitor treatment who are experiencing dermal toxicity. The trial is expected to commence by the end of 2024.

Azitra, Inc. is dedicated to developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The company has developed a proprietary platform that includes a microbial library of around 1,500 unique bacterial strains. These strains can be screened for therapeutic characteristics. The platform is enhanced by artificial intelligence and machine learning technologies, which help analyze, predict, and screen the library for drug-like molecules. Azitra’s primary focus is on developing genetically engineered strains of Staphylococcus epidermidis, which the company views as an optimal therapeutic candidate for dermatologic treatments.