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Praxis Precision Medicines to Present Analyses of Patient-Focused, Clinically Meaningful Endpoints from Essential1 Study of Ulixacaltamide in Essential Tremor at the 2023 MDS International Congress
BOSTON, Aug. 28, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic
About this update from Praxis Precision Medicines, Inc.
[{"type":"text","content":"BOSTON, Aug. 28, 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 that it will be presenting analyses highlighting patient-focused endpoints from its Essential1 study of ulixacaltamide (PRAX-944) in essential tremor (ET) at The International Parkinson and Movement Disorder Society’s (MDS) International Congress of Parkinson's Disease and Movement Disorders®, taking place in Copenhagen, Denmark. “Recent FDA guidance highlights the importance of patient-focused clinical outcome assessments related to treatment effect. Using data from Essential1, we define for the first time what clinically meaningful change is for adults with ET, with our results showing sustained improvement in patients’ daily functioning,” said Marcio Souza, president and chief executive officer of Praxis. “The design of our upcoming Phase 3 program for ulixacaltamide applies these insights. We look forward to presenting our analyses highlighting modified Activities of Daily Living 11 as a reliable endpoint to measure the potential efficacy and durability of ulixacaltamide at this year’s MDS Congress.” Presentation Details: Patient-Focused, Clinically Meaningful Endpoints as Evidence of Improved Outcomes and Durability of Effect Following Ulixacaltamide Treatment in Adults with Essential Tremor: Findings from Essential1 Viewing Dates/Times: Monday, August 28 – Wednesday, August 30 1:00 p.m. – 3:00 p.m. CEDTPoster: LBA-19Summary: While the concept of clinically meaningful change has been extensively studied in other movement disorders and neurological conditions, this has not been evaluated in ET. This study represents the first time a Meaningful Score Difference has been defined in ET using a large patient dataset and a focus on measures determined to be most meaningful to patients. In this poster presentation, Praxis will highlight modified Activities of Daily Living 11 (mADL11) as a reliable, patient-focused clinical outcome assessment for measuring ulixacaltamide efficacy and durability of effect, with important decision-making implications for ET therapies. About Ulixacaltamide Ulixacaltamide is a differentiated a...