Planning for a Phase 1 clinical trial to explore the safety and tolerability of escalating doses of EPX-100, a potential oral treatment for Dravet syndrome, is underway, Epygenix Therapeutics, the investigative therapy’s developer, announced.
After completion of this first study in healthy individuals, the company plans to initiate Phase 2 trials evaluating EPX-100, a repurposed antihistamine thought to have antiepileptic properties, in Dravet patients.
Plans for EPX-100’s clinical development were cleared with the U.S. Food and Drug Administration’s recent approval of the company’s Investigational New Drug Application (IND) — an essential first step in launching a clinical trial.
“We are very excited with EPX-100 IND approval from the FDA, and this allows us to test EPX-100 in humans, and eventually Dravet patients,” Hahn-Jun Lee, PhD, president and CEO of Epygenix Therapeutics, said in a press release. “Our team will rigorously monitor all safety and efficacy tests for EPX-100 as we advance this drug to the clinic.”
The compound was found to be a strong suppressor of spontaneous convulsive behavior in fish models of Dravet syndrome. Unlike its mechanisms of action as an antihistaminic, EPX-100’s antiepileptic properties are thought to stem from its ability to modulate signaling pathways for serotonin, a chemical messenger present in many parts of the brain.
The first trial will compare the safety and overall pharmacokinetics of increasing doses of EPX-100 compared to an inactive placebo in healthy people. Pharmacokinetics refers to the movement of compounds into, through, and out of the body; essentially, how the body affects a medicine.
Researchers will also assess the impact of food on the stability and bioavailability of EPX-100 in the body, as well as on different treatment regimens.
Results from this first study will be used to establish an optimal dose and regimen to be used in trials in people with Dravet syndrome.
“This is an exciting moment for us to move EPX-100 from preclinical trials into human testing,” said Jules Mitchel, PhD, president of Target Health, the lead contract research organization providing support for the initial study.
“We are looking forward to the continuation of our collaboration with Epygenix to support successful completion of EPX-100 Phase 1 studies,” Mitchel added.
Further details about this trial, including its study sites, are not yet available.
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