Praxis gains on epilepsy study

 Praxis Precision Medicines Inc 

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 provided an update on its Phase 2a proof of concept study evaluating PRAX-628 in epilepsy patients with photo paroxysmal response (PPR), also known as photosensitivity. 

PPR studies measure electroencephalogram (EEG) signatures after intermittent photic stimulation and are used as an indicator of anti-seizure efficacy.

“The strength and consistency of response across both study arms, combined with a continued positive tolerability and safety profile, build on our earlier conviction that PRAX-628 has the potential to be the first precision sodium channel modulator for focal epilepsy patients. With such a clear response, we have advanced our planning of the focal epilepsy efficacy study for PRAX-628, expected to begin in the second half of 2024,” said Marcio Souza, president and chief executive officer of Praxis.

• In the 15mg cohort, partial response was 20%, with complete response of 80%.
•  In the 45mg, the complete response was 100%.

The Phase 2a study builds on results from animal studies and the Phase 1 dose escalation study in healthy volunteers.

• PRAX-628 demonstrated preclinical efficacy in the maximal electroshock seizure (MES) model.
•  PRAX-628 was generally well-tolerated at all tested doses in the Phase 1 study.
•  Pharmacokinetic data from the Phase 1 study demonstrated dose-dependent exposure supporting once-daily dosing without titration to achieve potentially therapeutically effective drug concentration levels.
•  Further analysis of patients in the Phase 1 study using quantitative EEG data showed a pharmacodynamic effect at all dose levels and was significantly different from placebo.

https://www.benzinga.com/general/biotech/24/03/37941441/why-praxis-precision-medicines-stock-is-trading-higher-tuesday