Wave Life Sciences Ltd. announced that the planned Phase 2/3 efficacy and safety trial for its lead Duchenne muscular dystrophy (DMD) clinical program has been selected for the U.S. Food and Drug Administration (FDA) pilot program for complex innovative trial designs (CID). The selection was based on the design of Wave’s Phase 2/3 clinical trial of suvodirsen (WVE-210201), an investigational therapy for boys with DMD who are amenable to exon 51 skipping. In evaluating submissions for the CID pilot program, the FDA considered two key criteria: the innovative features of the trial design and the therapeutic need (i.e., therapies being developed for use in disease areas where there are limited or no treatment options). Wave’s application for the CID pilot program includes a plan to leverage DMD historical control data to augment the placebo arm of the suvodirsen Phase 2/3 clinical trial, among other innovative design elements. Through this pilot program, Wave intends to reduce the number of patients required to deliver conclusive clinical efficacy results, thereby minimizing the number of patients required in the placebo treatment arm and potentially accelerating study completion. As a participant in the pilot program, the company will also have additional opportunities to meet with FDA staff to discuss the design elements of the trial, including the use of Bayesian methods to adapt the trial and allow for more efficient and productive clinical determinations. Details of Wave’s Phase 2/3 trial design will be presented at upcoming scientific meetings.