Business
Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2021 Financial Results
Initiated PRAX-114 Phase 2 Acapella Study for adjunctive treatment of Major Depressive Disorder (MDD) Enrollment on track for 1H22 topline results in PRAX-114
About this update from Praxis Precision Medicines, Inc.
[{"type":"text","content":"Initiated PRAX-114 Phase 2 Acapella Study for adjunctive treatment of Major Depressive Disorder (MDD) Enrollment on track for 1H22 topline results in PRAX-114 Phase 2/3 Aria Study for monotherapy treatment of MDD PRAX-114 to advance in Phase 2b study in women with menopausal and mood symptoms PRAX-944 Phase 2b study for treatment of essential tremor to initiate in 3Q21; Phase 2a topline results expected by the end of 2021 PRAX-562 Phase 1 healthy volunteer study completed with dose up to 150 mg and favorable safety profile Cash and investments of $339.2 million as of June 30, 2021 supports runway into 2Q23 CAMBRIDGE, Mass., Aug. 16, 2021 (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 imbalance, today provided a corporate update and reported financial results for the second quarter ended June 30, 2021. “The second quarter marked another inflection point for Praxis as we make progress toward being a diversified, late-stage, CNS focused company,” said Marcio Souza, president and chief executive officer of Praxis. “We expect to end the year with six controlled trials across our three clinical programs, including the ongoing registrational and Phase 2 studies in depression. As we know too well, the needs of people with CNS disorders are urgent and we are committed to bringing meaningful treatments to patients.” Recent Business Highlights and Upcoming Milestones: Psychiatry Praxis started dosing patients in the Acapella Study (Study 214), a PRAX-114 Phase 2 placebo-controlled study for adjunctive treatment of Major Depressive Disorder (MDD), in July 2021. Topline results from the Acapella Study are expected in the first half of 2022. Praxis expects topline results from the ongoing PRAX-114 Phase 2/3 Aria Study for monotherapy treatment of MDD in the first half of 2022. The Aria Study is intended to serve as one of two trials required by the U.S. Food and Drug Administration (FDA) to demonstrate clinical efficacy to support registration of PRAX-114 for monotherapy treatment of MDD. The Company reported topline results from the PRAX-114 Phase 2a Part B proof-of-concept trial for treatment of perimenopausal depression (PMD) and consolidated saf...