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Praxis Precision Medicines Provides Corporate Update and Reports First Quarter 2023 Financial Results
Ulixacaltamide essential tremor End-of-Phase 2 meeting with FDA scheduled for June 2023 PRAX-628 Phase 1 study results support preclinical profile indicating
About this update from Praxis Precision Medicines, Inc.
[{"type":"text","content":"Ulixacaltamide essential tremor End-of-Phase 2 meeting with FDA scheduled for June 2023 PRAX-628 Phase 1 study results support preclinical profile indicating potential for best-in-class-efficacy for focal epilepsy Cash and investments of $85.8 million as of March 31, 2023 supports runway into 2Q24 BOSTON, May 11, 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 first quarter 2023. “Each of our four clinical-stage programs has made meaningful progress this year and we anticipate additional value inflecting milestones throughout the pipeline in the coming months,” said Marcio Souza, president and chief executive officer of Praxis. “We shared positive topline results earlier today from the Phase 1 study of our next-generation, functional-state selective small molecule, PRAX-628, and believe that this program has the potential to change the treatment paradigm for people living with focal epilepsy. We look forward to initiating a PRAX-628 Phase 2 study in focal epilepsy later this year, and also plan to share results from our PRAX-562 and PRAX-222 programs in rare, genetic epilepsies. Finally, we eagerly anticipate the upcoming ulixacaltamide End-of-Phase 2 FDA meeting in June and intend to start a Phase 3 program in essential tremor shortly thereafter.” Recent Business Highlights and Upcoming Milestones: Cerebrum™ Small Molecule Platform Praxis announced topline results from the ulixacaltamide (PRAX-944) Phase 2 Essential1 study for the treatment of moderate to severe essential tremor (ET) in March 2023. An end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) is scheduled for June 2023. Based upon the observed efficacy and safety profile, Praxis intends to initiate the ulixacaltamide Phase 3 program for the treatment of ET in the second half of 2023 following FDA feedback on the clinical registration plan and alignment on the overall development program.The Company plans to present additional results from the Essential1 study at upcoming medical conference meetings and company events: Essential1 topline results po...