vormatrigine (PRAX-628) / Praxis Precision Medicines - LARVOL DELTA

Updates from the First-in-human Phase 1 Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect of Vormatrigine in Healthy Participants (P11-4.006). (PubMed, Neurology) - "Petrou has received intellectual property interests from a discovery or technology relating to health care. Marcio Souza has received personal compensation for serving as an employee of Praxis Precision Medicines."

Clinical • Journal • P1 data • PK/PD data

Vormatrigine (PRAX-628) for Focal Onset Seizures and Generalized Epilepsy (GlobeNewswire) - "Praxis has initiated the RADIANT Phase 2, open-label, single-arm study for FOS and generalized epilepsy assessing seizure burden with vormatrigine treatment, with topline results expected by mid-year 2025. Praxis has also initiated the POWER1 Phase 2/3 registrational study of vormatrigine for treatment resistant FOS, with topline results anticipated in the second half of 2025. POWER2, the second registrational study for FOS, is on track to begin enrollment in the second half of 2025."

New trial • P2 data • P2/3 data • CNS Disorders • Epilepsy

Updates from the First-in-human Phase 1 Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect of Vormatrigine in Healthy Participants (AAN 2025) - "Vormatrigine demonstrated consistent safety, tolerability, and PK profiles, with no significant food effect. These results support flexible dosing regimens up to 45mg in the ongoing vormatrigine ENERGY program."

Clinical • P1 data • PK/PD data

Praxis Precision Medicines to Host PRAX-628 Program Update (GlobeNewswire) - "Praxis Precision Medicines...announced that it will host a virtual program update to discuss its PRAX-628 program in epilepsy on Tuesday, March 26, 2024 at 8:00 a.m. ET."

Clinical • CNS Disorders • Epilepsy

Praxis Precision Medicines to Present at the American Academy of Neurology 2023 Annual Meeting (GlobeNewswire) - "Praxis Precision Medicines, Inc....announced that it will deliver presentations on its clinical stage programs at the upcoming American Academy of Neurology (AAN) 2023 Annual Meeting, held April 22-27, 2023 in Boston, Massachusetts....'Also, we expect to dose the first patients in our PRAX-222 EMBRAVE study and PRAX-562 EMBOLD study within the coming weeks and are excited to share data supporting these programs. Finally, we look forward to sharing new in-vivo results for PRAX-628 that highlight this program’s potential to be a best-in-class treatment for focal epilepsy patients'."

Clinical data • Preclinical • CNS Disorders • Epilepsy

Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results (GlobeNewswire) - "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."

P1 data • P2 data • CNS Disorders • Epilepsy

Praxis Precision Medicines to Present at the American Epilepsy Society 2022 Annual Meeting (GlobeNewswire) - "Praxis Precision Medicines, Inc...announced that it will deliver presentations on its epilepsy programs at the American Epilepsy Society (AES) 2022 Annual Meeting, held December 2-6, 2022 in Nashville, Tennessee....'It’s an incredibly exciting time for Praxis and our epilepsy portfolio, with first-in-patient studies for PRAX-222 and PRAX-562 and a first-in-human study for PRAX-628 expected to start shortly'....Together with pharmacokinetic findings demonstrating a 13-fold increase in concentrations compared to preclinical maximal electroshock seizure effects, our results are consistent with earlier work suggesting a wide therapeutic window for PRAX-562."

New trial • P1 data • Preclinical • CNS Disorders • Epilepsy

Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2022 Financial Results (GlobeNewswire) - "Praxis expects to initiate a PRAX-628 Phase 1 study in the fourth quarter of 2022 and subsequently initiate a Phase 2 study in focal epilepsy in 2023."

New P1 trial • New P2 trial • CNS Disorders • Epilepsy

Praxis Precision Medicines Showcases Largest Targeted Epilepsy Portfolio in Industry at 2022 Epilepsy Day - "Updates from Praxis’ three most advanced epilepsy programs, each of which is expected to be clinical stage by year-end 2022: PRAX-222: Investigational New Drug (IND) submitted to the U.S. Food and Drug Administration (FDA) proposing a seamless study design for SCN2A patients with early-onset seizures; PRAX-562:...A Phase 2 clinical study in cohorts of children with SCN2A epilepsy, SCN8A epilepsy, and Tuberous Sclerosis Complex (TSC) is expected to initiate in 2H2022; PRAX-628: Expected initiation of a Phase 1 study in the fourth quarter of 2022 and a Phase 2 study in focal epilepsy in 2023; A review of the significant progress in Praxis’ early-stage epilepsy pipeline, including plans to declare antisense oligonucleotide (ASO) candidates for PRAX-080 for PCDH19 and PRAX-090 for SYNGAP1 in 2023."

New P1 trial • New P2 trial • CNS Disorders • Epilepsy