Applied Therapeutics, Inc. announced that the ACTION-Galactosemia Kids Phase 3 trial has demonstrated a trend in clinical benefit favoring AT-007 vs. placebo. The study is designed to evaluate the impact of AT-007 vs.

placebo on clinical outcomes in children with Classic Galactosemia, with a review of safety and efficacy every 6 months by a firewalled Data Monitoring Committee (DMC) until the study reaches statistical significance. Review of the data at 12 months of treatment by the DMC indicated that while the study primary endpoint has not yet reached statistical significance, a trend exists favoring AT-007 vs. placebo.

The clinical benefit at this early time point was most pronounced in patients with significant deficits in clinical performance at baseline. Safety data demonstrated that AT-007 continues to be safe and well tolerated. The study will proceed in blinded format to the next review at 18 months of treatment.

In the meantime, the Company will meet with the EMA to discuss potential submission of an MAA based on existing data for conditional approval.