Praxis(US:PRAX)2023-05-16 14:55Ulixacaltamide (PRAX-944) for Essential Tremor (ET) and Parkinson's Disease - Praxis plans to initiate Phase 3 trial for Essential Tremor in the second half of 2023[24] - Approximately 1 million people in the United States are diagnosed with ET and on treatment, while another estimated 1 million patients remain untreated[32] - About 40% of patients who seek treatment for ET discontinue within 2 years, which translates to roughly 200,000 patients annually[34] - In the Essential1 Phase 2b ET study, ulixacaltamide showed an improvement of -301 in mADL compared to -144 with placebo (p=0126), and an improvement of -36 in ADL compared to -107 with placebo (p = 0026) [48] - In the mITT analysis excluding ET patients with intention tremor, ulixacaltamide showed an improvement of -312 in mADL compared to -041 with placebo (p=0032), and an improvement of -286 in mADL excluding PS compared to -001 with placebo (p = 0008)[61] PRAX-562 for SCN2A, SCN8A & Other DEEs - Praxis anticipates topline results from the Phase 2 EMBOLD study in the fourth quarter of 2023[69] - PRAX-562 demonstrated a therapeutic index of 172x in preclinical studies[83] - PRAX-562 has been generally well tolerated in over 130 healthy volunteers in Phase 1 trials[90] PRAX-628 for Focal Epilepsy - Praxis plans to initiate a study for Focal Epilepsy in the fourth quarter of 2023[98] - Focal epilepsy affects approximately 2 million people in the US, representing 60% of epilepsy cases[99, 100] PRAX-222 for SCN2A-GoF ASO - Praxis expects topline safety results from the first dose cohort (Part 1) of the EMBRAVE Study in the second half of 2023[118]