PRAX - Praxis Precision Medicines Reports Positive Results of PRAX-628 Study Evaluating Photo Paroxysmal Response (PPR) Achieving 100% Response in Treated Patients | Benzinga
In the 45 mg cohort, 100% of patients achieved a complete response
In the 15 mg cohort, 80% of patients achieved a complete response and 20% achieved a partial response
Safety was consistent with prior dose escalation study and PK analysis confirmed therapeutic exposures
Praxis plans to initiate an efficacy study in focal onset epilepsy in the second half of 2024
BOSTON, March 26, 2024 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), 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, today provided an update on its Phase 2a proof of concept study evaluating PRAX-628 in epilepsy patients with PPR. 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. We extend our thanks to the patients who participated in this PPR study," said Marcio Souza, president and chief executive officer of Praxis.
| Summary of Response |
| Cohort |
| Partial Response Rate |
| Complete Response Rate |
| Total Response |
| 15mg |
| 20% (1) |
| 80% (4) |
| 100% (5) |