Prelude Therapeutics Incorporated announced on September 10, 2026, that the U.S. Food and Drug Administration (FDA) has cleared the company to proceed with a Phase 1 study under its Investigational New Drug (IND) application for PRT13722.
PRT13722 is an oral KAT6A selective degrader being developed for the treatment of patients with HR+/HER2- breast cancer. The company anticipates that patient enrollment for this study will begin in the fourth quarter of 2026.
The Phase 1 study is a first-in-human, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PRT13722. The study will test the drug as a monotherapy and in combination with endocrine and targeted therapies in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer.
Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude, commented on the clearance, stating that recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer. He noted that while dual KAT6A/B inhibitors have demonstrated overlapping toxicities, Prelude's approach of selectively degrading KAT6A aims to maximize the therapeutic window with enhanced efficacy and improved hematological safety, as supported by preclinical data.
