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.