FDA clears development of drug to treat cancer therapy-induced skin rash

Key takeaways:

• ATR-04 is currently being developed to treat dermal toxicity from epidermal growth factor receptor inhibitor cancer therapy.
• The phase 1/2 trial will commence in late 2024.

The FDA has cleared an investigational new drug application for a first-in-human phase 1/2 study of ATR-04 for moderate to severe dermal toxicity from epidermal growth factor receptor inhibitors, Azitra Inc. announced in a press release.

“Many cancer patients receive [epidermal growth factor receptor (EGFR)] inhibitors, which are efficacious for certain cancers,” Francisco Salva, MSc, president and CEO of Azitra, said in the press release. “However, these EGFR inhibitors often have significant side effects, resulting in rashes that require treatment with antibiotics, steroids or other medications.”

According to Salva, some of these patients must discontinue their cancer therapy due to these side effects as there are no approved therapies for this skin toxicity, resulting in a high patient burden.

A naturally derived Staphylococcus epidermidis strain, ATR-04 is a live biotherapeutic product candidate that has been engineered to delete an antibiotic resistance gene, ensuring response to medication. It is currently being developed for the treatment of EGFR inhibitor-associated dermal toxicity, a skin rash caused by the suppression of skin immunity during this cancer treatment.

According to the release, approximately 150,000 patients suffer from EGFR inhibitor-induced dermal toxicity in the U.S., representing a group of patients with an unmet need. Following the clearance of this application, the company plans to initiate the phase 1/2 trial by the end of 2024.