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Praxis Precision Medicines Reports Positive Results of PRAX-628 Study Evaluating Photo Paroxysmal Response (PPR) Achieving 100% Response in Treated Patients | ||||||||||||||||||||||||||
By: GlobeNewswire - 26 Mar 2024 | Back to overview list |
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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.
PRAX-628 for Focal Epilepsy:
Praxis will host a call on Tuesday, March 26 at 8:00 am ET to discuss the study results, and will be joined by Dr. Daniel Friedman, Professor of Neurology at NYU Grossman School of Medicine. To register for the call, please click here. The live webcast and replay will be available through the Events & Presentations page of the Investors and Media section of the company’s website at www.praxismedicines.com. About PRAX-628 About Praxis? Forward-Looking Statements The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials; the expected timing of clinical trials, data readouts and the results thereof, and submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials; and other risks concerning Praxis’ programs and operations as described in its Annual Report on Form 10-K for the year ended December 31, 2023 and other filings made with the Securities and Exchange Commission. Although Praxis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on information and factors currently known by Praxis. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Praxis undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. CONTACT: Investor Contact: Praxis Precision Medicines investors@praxismedicines.com 857-702-9452 Media Contact: Dan Ferry Life Science Advisors Daniel@lifesciadvisors.com 617-430-7576 |
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