Business
Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2023 Financial Results
On track to initiate Phase 3 studies for ulixacaltamide in Q4 2023 after favorable End-of-Phase 2 meeting with FDA PRAX-628 Phase 1 study showed consistent
About this update from Praxis Precision Medicines, Inc.
[{"type":"text","content":"On track to initiate Phase 3 studies for ulixacaltamide in Q4 2023 after favorable End-of-Phase 2 meeting with FDA PRAX-628 Phase 1 study showed consistent safety profile and target engagement in measures of qEEG activity at all doses with first administration Praxis will hold an R&D Portfolio Day on October 2 Cash of $124.3 million as of June 30, 2023 expected to support runway into Q1 2025 BOSTON, Aug. 09, 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 second quarter 2023. “Our four clinical-stage programs continue to make great progress, and we are excited to be advancing ulixacaltamide into Phase 3,” said Marcio Souza, president and chief executive officer of Praxis. “Our epilepsy portfolio continues to advance, with studies ongoing in each of our three clinical-stage programs that we expect to read out by the end of the year. We are planning to hold an R&D portfolio day on October 2 to elaborate on our science and clinical progress, including more details about the Phase 3 program for ulixacaltamide and additional data from the Essential1 study.” Recent Business Highlights and Upcoming Milestones: Cerebrum™ Small Molecule Platform In June 2023, Praxis shared the outcomes of its end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and is planning to initiate two Phase 3 studies as part of the registrational program, using mADL11 as the primary outcome measure. One study will be a parallel control design and the other using a randomized withdrawal design. Both trials will evaluate essential tremor patients at a 60 mg dose of ulixacaltamide for 12 weeks after a short titration period. The EOP2 meeting confirmed other program aspects including safety database, clinical pharmacology and toxicology requirements for registration. Praxis intends to begin enrolling patients in the fourth quarter of 2023, with read outs expected in the second half of 2024.In August 2023, Praxis shared the results of two additional analyses of the Essential1 dataset that showed durable effect to 14 weeks and maintenance of ...