DAVIS, Calif., April 9, 2020 /PRNewswire/ -- EicOsis LLC, a
pharmaceutical startup developing a new class of oral non-narcotic
analgesics based on inhibition of the soluble Epoxide Hydrolase
(sEH) enzyme, announced today that the U.S. Food & Drug
Administration (FDA) has granted Fast Track designation to its lead
drug candidate, EC5026, for the treatment of neuropathic pain. Fast
Track designation confers important benefits, including the
potential eligibility for Priority Review of a New Drug
Application.
EC5026 is a first-in-class, orally administered, potent small
molecule that inhibits sEH, a key regulatory enzyme involved in the
metabolism of endogenous anti-inflammatory lipid mediators.
Inhibition of sEH treats pain by preventing the breakdown of these
natural analgesic and anti-inflammatory fatty acids that then
increase within cells to levels sufficient to treat pain. sEH
inhibitors developed by EicOsis have already shown efficacy in
reducing inflammatory and neuropathic pain in rodent assays,
without the addictive potential or adverse effects associated with
opioids or NSAIDs, as well as relieving natural-onset pathological
pain in horses, dogs and cats. EC5026 received IND clearance from
the FDA in October 2019 and is
currently the subject of a phase 1a clinical trial in healthy
volunteers. EicOsis plans on advancing to phase 1b clinical trials in Fall 2020.
Neuropathic pain is estimated to affect 7–10% of the general
population, substantially affecting day-to-day functioning and
quality of life. Currently available treatments for neuropathic
pain remain ineffective and are associated with frequent adverse
effects and poor tolerability.
Dr. Laura Carbone, MD, MS,
Division Chief and Professor Medicine at Augusta University
emphasized the need for effective pain medicine, "I know my patient
is suffering and sadly I know I've gone through everything
available to help. I struggle, we both struggle, to find a
way to make today better as we both hope for something better to
come that will Really help. That is the daily reality of
pain."
Patients with neuropathic pain are frequently prescribed opioids
to manage their symptoms, with the associated risk of opioid misuse
and addiction. As a potent analgesic, EC5026 has great potential to
address the pressing need for effective, nonaddictive alternative
drugs for pain management, decrease the use of prescription
opioids, and reduce the opioid abuse epidemic.
The discovery and development of EC5026 has been supported by
funding from the National Institutes of Health (NIH) through the
Blueprint Neurotherapeutics Network (BPN) and the NIH's Helping to
End Addiction Long-term (HEAL) Initiative.
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SOURCE EicOsis