Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2022 Financial Results

PRAX-944 Phase 2b Essential1 Study topline results expected in 4Q22; primary endpoint updated to efficacy

PRAX-562 Phase 1 study completed, confirming biomarker change and potential for wide therapeutic window

Cash and investments of $165.4 million as of June 30, 2022 supports runway into 1Q24

BOSTON, Aug. 08, 2022 (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 of 2022.

“Through the lens of epilepsy genetics, we have efficiently built a broad portfolio of clinical stage and preclinical CNS programs with uncorrelated risk,” said Marcio Souza, president and chief executive officer of Praxis. “In our clinical stage programs, recent data for PRAX-944 in essential tremor and for PRAX-562 have been encouraging and give us greater confidence as we trend toward key milestones later this year. Reflecting this increased confidence, we updated the primary endpoint in the ongoing Essential1 Study to Modified Activities of Daily Living, the FDA-suggested efficacy endpoint for ET. The results from the PRAX-562 Phase 1 study deepen our conviction that we have a well-tolerated and differentiated sodium channel blocker with potential for a higher therapeutic index than existing therapies.”

Recent Business Highlights and Upcoming Milestones:

Movement Disorders

• In May 2022, Praxis reported positive topline results from Part B of its Phase 2a study evaluating the safety and efficacy of PRAX-944 for the treatment of essential tremor (ET). In the study, treatment with PRAX-944 resulted in clinically meaningful improvements in function, which were supported by improvements in tremor amplitude.
  • During the open-label period of the trial, patients treated with PRAX-944 demonstrated mean improvement from baseline of 42% in the Modified Activities of Daily Living (ADL) score (N=11, nominal p