Azitra (NYSE American: AZTR) has announced amendments to its ongoing Phase 1/2 clinical trial of ATR04-484 that significantly expand patient eligibility to include individuals with rash associated with KRAS and MEK inhibitors.
According to Azitra, the expanded eligibility also includes patients with neurofibromatosis type 1 (NF1) with rash associated with MEK inhibitors. The amendments also shorten the required washout periods for antibiotics and steroids. Together, these changes broaden the potential treatment opportunities for ATR-04 beyond its initial focus on epidermal growth factor receptor inhibitor (EGFRi)-associated skin rash, while expanding the pool of eligible patients to facilitate recruitment.
In a statement, Francisco Salva, CEO of Azitra, commented, “These expansions to the Phase 1/2 trial protocol represent a significant step for our ATR-04 program, increasing the possibility for this innovative treatment to benefit cancer and certain neurofibromatosis patients experiencing debilitating rash due to several targeted therapies.”
He added, “While these therapies have transformed treatment for many patients, associated skin toxicities can significantly impact quality of life and interfere with treatment. By expanding our study to include patients with rash due to KRAS and MEK inhibitors, we are broadening the potential opportunity for ATR-04. Equally important, we believe the additional protocol modifications will facilitate patient recruitment and help accelerate enrollment. Following our recent advancement to Cohort 2, we are encouraged by the continued progress of this program and its potential to provide a new treatment option for patients affected by debilitating skin conditions.”
