Business
Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results
Ulixacaltamide (PRAX-944) Phase 2b Essential1 study topline results for essential tremor expected in 1Q23; Praxis to enter quiet period following market close
About this update from Praxis Precision Medicines, Inc.
[{"type":"text","content":"Ulixacaltamide (PRAX-944) Phase 2b Essential1 study topline results for essential tremor expected in 1Q23; Praxis to enter quiet period following market close on Thursday, February 9 Topline results expected for each of three clinical-stage epilepsy programs in 2023 – PRAX-222 first-in-patient EMBRAVE Study safety data mid-2023, PRAX-628 first-in-human Phase 1 data mid-2023, PRAX-562 Phase 2 EMBOLD Study results in 2H23 Cash and investments of $100.5 million as of December 31, 2022 supports runway into 1Q24 BOSTON, Feb. 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 provided a corporate update and reported financial results for the fourth quarter and full year 2022. “This year is set up to be transformative for Praxis and for the patients that we serve, with topline results for the ulixacaltamide Essential1 study imminent and data expected from each of our four clinical-stage programs in 2023,” said Marcio Souza, president and chief executive officer of Praxis. “Based on our understanding of epilepsy genetics and unique capabilities to translate these insights into therapies for patients suffering from a broad range of CNS disorders, we have built two proprietary platforms, Cerebrum™ for small molecules and Solidus™ for antisense oligonucleotides, that we expect will drive continuous innovation and value creation this year and beyond.” Recent Business Highlights and Upcoming Milestones: Cerebrum™ Small Molecule Platform Praxis expects topline results from the ongoing ulixacaltamide (PRAX-944) Essential1 study for the treatment of moderate to severe essential tremor (ET) in the first quarter of 2023. Essential1 is a randomized, double-blind, placebo-controlled, dose-range-finding Phase 2b trial evaluating the efficacy, safety and tolerability of once-daily daytime treatment of 60 or 100 mg of ulixacaltamide compared to placebo after 56 days. The primary endpoint is change from baseline to day 56 in the modified Activities of Daily Living (mADL1) score. Following topline results, Praxis intends to request an end-of-Phase 2 meeting with the FDA and initiate its ulixacaltamide Phase 3 develop...