Prelude Therapeutics Incorporated announced that the U.S. Food and Drug Administration, (FDA) cleared the company to proceed with a Phase 1 study under its Investigational New Drug Application (IND) for PRT3789, a first-in-class potent and selective SMARCA2 (BRM) protein degrader. The company anticipates dosing the first patient in First Quarter of 2023. The Phase 1 study of PRT3789 will enroll patients with advanced solid tumors in a biomarker selected SMARCA4 mutated population.

The trial will be enriched for patients with non-small cell lung cancer, where these mutations are frequently present. The primary endpoints of the study include safety, tolerability and establishment of a recommended phase two dose with additional evaluation of pharmacokinetics and pharmacodynamic parameters, and evidence of clinical activity.