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Praxis Precision Medicines Inc (NASDAQ:PRAX) announced topline results from the PRAX-628 Phase 1 healthy volunteer study evaluating single ascending doses (SAD) and multiple ascending doses (MAD) of PRAX-628.
PRAX-628 is a next-generation, functionally selective small molecule targeting the hyperexcitable state of sodium channels in the brain.
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PRAX-628 is being developed as a once-daily oral treatment for adult focal onset epilepsy.
Related: Despite Trial Failure, Praxis Still Seeks Advancing Essential Tremor Program Into Phase 3 Study.
In the study, PRAX-628 or placebo was administered to 40 healthy participants (n=30, placebo=10)
SAD cohorts evaluated PRAX-628 doses ranging from 5 mg to 45 mg, and MAD cohorts evaluated PRAX-628 doses of 20 mg and 30 mg, resulting in concentrations of more than 15-fold the mouse Maximal Electroshock Seizure model (MES) EC50.
PRAX-628 was generally well-tolerated at all tested doses.
PK data demonstrated dose-dependent exposure supporting once-daily dosing without titration to achieve potentially therapeutically effective drug concentration levels.
The most common treatment-related adverse events (AEs) across all cohorts were fatigue, dizziness, somnolence, headache, disturbance in attention, and nausea.
Praxis intends to advance PRAX-628 into a Phase 2 study in focal epilepsy in Q4 of 2023.
Price Action: PRAX shares are down 0.93% at $1.07 on the last check Thursday.
27% profit every 20 days?
This is what Nic Chahine averages with his option buys. Not selling covered calls or spreads… BUYING options. Most traders don’t even have a winning percentage of 27% buying options. He has an 83% win rate. Here’s how he does it.