Praxis Unveils Perimenopausal Depression Trial Data

Praxis Precision Medicines Inc PRAX has reported results from its PRAX-114 Phase 2a Part B proof-of-concept trial for perimenopausal depression (PMD).
PRAX-114 60 mg suspension formulation (n=6) for 14 days in an outpatient setting showed rapid and sustained improvements in menopausal and mood symptoms.
Results trended toward baseline following discontinuation of PRAX-114, suggesting the need for continued treatment.
PRAX-114 was well tolerated, with no change in the overall PRAX-114 safety profile.
Treatment with PRAX-114 resulted in mean decreases from baseline at Day 15 of 60% in frequency of moderate-to-severe hot flashes and 68% in the total score of the Perimenopausal Depression Questionnaire.
Treatment with PRAX-114 resulted in mean decreases from baseline at Day 15 of 47% in the HAM-D total score, 65% in the HAM-A total score, and 40% in the Symptoms of Depression Questionnaire.
Praxis Precision plans to advance PRAX-114 to a Phase 2b study in women with menopausal and mood symptoms, with trial details to be disclosed by the end of 2021.
PRAX-114 is an extrasynaptic GABAA receptor preferring positive allosteric modulator.
Praxis ended Q2 with $339.2 million in cash, cash equivalents, and marketable securities.
Price Action: PRAX shares are down 6.01% at $12.97 during the market session on the last check Monday.

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