Negative results from PRAX 113 phase II/III monotherapy ARIA study in major depressive disorder.
Praxis Precision Medicines, Inc. 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, announced that the Phase II/III Aria Study evaluating the efficacy and safety of PRAX-114 for monotherapy treatment of major depressive disorder (MDD) did not achieve statistical significance on the primary endpoint of change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15, or on any secondary endpoints.
Praxis intends to share detailed results in an upcoming medical presentation or publication.
The strategic realignment will result in a reduction of the Company’s workforce and future operating expenses. As a result of the realignment, the Company’s cash runway will now extend into 2024. The strategic alignment will focus on delivering Phase IIb results for PRAX-944 in essential tremor (Essential1 Study) and proof-of-concept for PRAX-562 in epilepsy and advancing the pre-clinical pipeline.