FDA grants fast track designation to ATR-04 for cancer therapy-induced skin rash

Key takeaways:

• ATR-04 has received a fast track designation from the FDA for epidermal growth factor receptor inhibitor-associated dermal toxicity.
• ATR-04 will be investigated in an upcoming phase 1/2 trial.

The FDA has granted fast track designation to topically applied ATR-04 for the treatment of moderate to severe epidermal growth factor receptor inhibitor-associated dermal toxicity, Azitra announced in a press release.

“We are thrilled to announce the FDA has granted fast track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of [epidermal growth factor receptor inhibitor-associated] skin rash,” Francisco Salva, MSc, Azitra’s CEO, said in the press release.

Recently cleared by the FDA for a first-in-human phase 1/2 trial, ATR-04 is a live biotherapeutic product candidate derived from the Staphylococcus epidermidis strain and engineered to delete an antibiotic resistance gene, ensuring response to medication. It is currently being developed for the treatment of epidermal growth factor receptor inhibitor-associated dermal toxicity, a skin rash caused by the suppression of skin immunity during cancer treatment.

“Many cancer patients receive [epidermal growth factor receptor] inhibitors, which often have significant side effects, resulting in rashes that require off-label treatment with antibiotics, steroids or other medications, or discontinuation of [epidermal growth factor receptor inhibitor] therapy,” Salva continued. “The skin toxicity creates a high burden for these cancer patients, with a profound impact on their quality of life.”

The acceptance of ATR-04 into the FDA’s fast track program expedites the review process for this drug with the hope of quickly addressing this unmet need.