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Praxis Precision Medicines Announces Positive Results of EEG Analysis of PRAX-628 Phase 1 Study
Composite qEEG measure showed change from placebo after first dose of 5 mg Effect in the composite qEEG measured through 10-day treatment period Ongoing
About this update from Praxis Precision Medicines, Inc.
[{"type":"text","content":"Composite qEEG measure showed change from placebo after first dose of 5 mg Effect in the composite qEEG measured through 10-day treatment period Ongoing PRAX-628 Phase 2 Photo-Paroxysmal Response (PPR) expected to read out in 2H 2023 BOSTON, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today 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. “We are very pleased to see that PRAX-628 reached the brain at therapeutic levels. Combined with the PRAX-628 data we have already seen, including its solid safety results, rapid onset and wide therapeutic window, we maintain our expectations that PRAX-628 has the potential to be the best-in-class treatment for patients suffering from focal epilepsy. We look forward to sharing the results of our ongoing Phase 2 PPR study later this year, and soon after initiating a Phase 2 study in focal epilepsy,” said Marcio Souza, president and chief executive officer of Praxis. Summary of PRAX-628 Phase 1 qEEG Analysis: In the Phase 1 study, PRAX-628 was administered to 40 healthy participants (PRAX-628 n=30, placebo n=10). Single ascending dose (SAD) cohorts evaluated PRAX-628 doses ranging from 5 to 45 mg and multiple ascending dose (MAD) 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 (~2h) for the SAD and all timepoints for the MAD portion. Additional results from the PRAX-628 Phase 1 study will be presented at an upco...