americanpharmaceuticalreviewDecember 16, 2019
EicOsis announced initiation of dosing for the first human subject in a Phase 1 trial of EC5026, the company's lead product candidate for pain management. This Phase 1a, single ascending dose trial will evaluate the safety and tolerability of single oral doses of EC5026 in healthy volunteers.
EC5026 is a first-in-class, orally administered, potent small molecule that inhibits sEH, a key regulatory enzyme involved in the metabolism of membrane fatty acids. Inhibition of sEH treats pain by preventing the breakdown of natural analgesic and anti-inflammatory fatty acids that increase within cells to levels sufficient to treat pain. sEH inhibitors developed by EicOsis have already shown efficacy for inflammatory and neuropathic pain in rodent assays, with no apparent adverse or addictive effects, as well as relieving natural-onset pathological pain in horses, dogs and cats.
"The initiation of this clinical trial is a significant milestone for EicOsis," said Dr. William K. Schmidt, Vice President of Clinical Development at EicOsis. "EC5026 represents a novel oral, non-opioid, pharmacological approach to treating moderate to severe pain with no evidence of addiction liability in preclinical models. We are very excited to see it advance to human clinical development."
Effective and safe options for pain management are currently insufficient and pain research is now a top priority in the United States. According to the influential Institute of Medicine's 2011 report on "Relieving Pain in America," approximately 100 million Americans suffer from chronic pain, with an associated $560-635 billion yearly cost in direct medical expenses and lost productivity.
The discovery and development of EC5026 by EicOsis and its advancement into clinical trials has been supported by funding from the National Institutes of Health (NIH) through the Blueprint Neurotherapeutics Network (BPN) of the NIH Blueprint for Neuroscience Research and the NIH's Helping to End Addiction Long-term (HEAL) Initiative.
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