US-based biopharmaceutical company Praxis Precision Medicines has reported positive results from a Phase I study of PRAX-628, a drug indicated for focal epilepsy.
The study analysed EEG activity in 30 patients who received PRAX-628 and ten who were given placebo.
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The study’s single ascending dose (SAD) cohorts assessed doses of PRAX-628 ranging from 5mg to 45mg, while the multiple ascending dose (MAD) cohorts evaluated doses of between 20mg and 30mg.
Praxis collected the EEG data over day one in the SAD cohort and three separate days of the ten-day MAD treatment period.
At all dose levels of SAD and MAD studies, qEEG analysis demonstrated a different pharmacodynamic effect from placebo at the Tmax timepoint of around two hours.
Praxis Precision Medicines president and CEO Marcio Souza said: “We are very pleased to see that PRAX-628 reached the brain at therapeutic levels.
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By GlobalData“Combined with the PRAX-628 data we have already seen, including its solid safety results, rapid onset and wide therapeutic window, we maintain our expectations that PRAX-628 has the potential to be the best-in-class treatment for patients suffering from focal epilepsy.
“We look forward to sharing the results of our ongoing Phase II PPR study later this year, and soon after initiating a Phase II study in focal epilepsy.”
The Phase II focal epilepsy study is expected to begin in the first half of next year.
PRAX-628 is a selective small molecule that targets the hyperexcitable state of sodium channels in the brain.
Based in Massachusetts, Praxis also develops therapies for rare neurological disorders using Cerebrum, a proprietary small molecule platform, and Solidus, an antisense oligonucleotide platform.
Earlier this year, the company reported positive topline results from a Phase I clinical trial of PRAX-628.
The drug was found to be well-tolerated at all tested doses, with common treatment-related adverse events such as nausea, dizziness, somnolence and fatigue observed.
