First Canadian Participant Dosed in ARGUS Trial, A Phase 2 Potentially Pivotal Study of EPX-100 Treatment of Dravet Syndrome
PARAMUS, N.J., June 1, 2022 (Newswire.com) - Epygenix Therapeutics, a clinical-stage biopharmaceutical company focused on genetically screening, discovering and developing safe, effective and patient-friendly drugs for rare and intractable forms of genetic epilepsy, today announces the dosing of the first Canadian study participant in the Phase 2 potentially pivotal ARGUS trial.
"We are very pleased about the progress in our ARGUS clinical trial program, which affirms our commitment to a global clinical development presence and broad access to our potential medicines," said Dr. Lorianne Masuoka, Chief Medical Officer of Epygenix Therapeutics. "Dravet syndrome patients across the world have substantial unmet need for effective treatments."
The primary goal of the ARGUS trial is to determine the efficacy of EPX-100 (clemizole hydrochloride) towards decreasing the number of countable convulsive seizure frequency in children and adults with Dravet syndrome who are 2 years and older.
About Dravet Syndrome
Dravet syndrome is one of the most drug-resistant forms of epilepsy. Eighty percent (80%) of cases of Dravet syndrome are caused by SCN1A mutation. However, the cause in other cases remains unknown. The disease usually appears during the first year of life and not only results in persistent seizures but also causes serious development symptoms such as sleep disturbances, delayed language and motor development, among other concerns.
About ARGUS Trial
The ARGUS trial is a 20-week randomized, double-blind, placebo-controlled trial in children and adults with Dravet syndrome and begins with a 4-week Observational Phase which will establish seizure frequency and eligibility for treatment, followed by a 4-week Titration Phase. Thereafter, the participant will enter a 12-week Maintenance Phase. Patients will have the opportunity to enter a 52-week Open-Label Extension phase at the end of the Maintenance Phase in which all patients will be administered EPX-100. The primary endpoint is the mean percent change in countable convulsive seizure frequency relative to the baseline (4-week Observational Phase).
Participant and site enrolment is ongoing in Canada, the United States, Spain, Australia, and the United Kingdom. More information is available at www.clinicaltrials.gov (NCT04462770) and www.argustrial.com.
About Epygenix Therapeutics, Inc.
Epygenix Therapeutics, Inc. is a precision medicine-based biopharmaceutical company focused on genetically screening, discovering and developing drugs to treat rare and intractable forms of genetic epilepsy, such as Dravet Syndrome. Epygenix is currently focused on developing EPX-100, EPX-200, and EPX-300. These drug candidates reduce convulsive behavior and electrographic seizure activity and were discovered in a zebrafish Dravet Syndrome model which replicates the genetic mutation and mimics the human pathology.
Epygenix's largest shareholder is Mstone Partners, an entrepreneurial biotech incubator in the form of a holding company which owns and manages a portfolio of drug development companies. Mstone focuses on developing novel and repurposed drugs for rare, neurodegenerative disorders. Since 2016, Mstone has invested in two companies in the US and one in Hong Kong which are now in advanced clinical stages with US FDA. Mstone has also established a number of portfolio companies under the Curestone Platform, which manages a portfolio of drug development companies in a centralized, hub-and-spoke model.
For more information, please visit www.epygenix.com.
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Source: Epygenix Therapeutics