Praxis Precision Medicines announces results of EEG analysis of PRAX-628 study

Praxis Precision Medicines announced the results from an analysis of EEG activity for subjects in the recent Phase 1 study that demonstrated pharmacodynamic activity across all dose levels for study subjects who received PRAX-628 at first administration as compared with subjects who received placebo. PRAX-628 is a next generation functionally selective small molecule targeting the hyperexcitable state of sodium channels in the brain, which is currently being developed as a rapid acting, once daily, oral treatment for adult focal onset epilepsy. In the Phase 1 study, PRAX-628 was administered to 40 healthy participants. Single ascending dose cohorts evaluated PRAX-628 doses ranging from 5 to 45 mg and multiple ascending dose cohorts evaluated PRAX-628 doses of 20 and 30 mg. EEG data were collected over the course of Day 1 in the SAD cohort and over three separate days during the course of the 10-day MAD treatment period. qEEG analysis showed a pharmacodynamic effect at all dose levels and was significantly different from placebo at the Tmax timepoint for the SAD and all timepoints for the MAD portion. Additional results from the PRAX-628 Phase 1 study will be presented at an upcoming medical conference. Praxis has begun a Phase 2 study for PRAX-628 in patients with a PPR to evaluate drug activity and dose finding, which is expected to report topline results in the second half of 2023. Based on these studies and the preclinical results, Praxis intends to advance PRAX-628 into a Phase 2 study in focal epilepsy in the first half of 2024.