DAVIS, Calif., Nov. 17, 2020 /PRNewswire/ -- EicOsis Human Health, a pharmaceutical company developing a new class of oral non-narcotic analgesics based on inhibition of the soluble Epoxide Hydrolase (sEH) enzyme, today announced the successful completion of a Phase 1a single-ascending dose clinical trial of EC5026, their oral drug candidate for the treatment of pain. No drug-related adverse events or changes in vital signs or clinical labs were observed, and the final clinical study report concludes that EC5026 is safe and well tolerated when given as a single oral dose ranging from 0.5 to 24 mg. The pharmacokinetic profile indicates that EC5026 is suitable for once daily oral dosing.
EC5026 is a small molecule that is a potent and highly selective inhibitor of sEH, a key regulatory enzyme involved in the metabolism of membrane fatty acids. Inhibition of sEH targets pain by preventing the breakdown of natural analgesic and anti-inflammatory fatty acids. EC5026 represents a first-in-class, orally administered, non-opioid, pharmacological approach to treating moderate to severe pain with no evidence of addiction liability in preclinical models. The target indications include chronic inflammatory and neuropathic pain. Because of its novelty, the FDA awarded Fast Track status to EC5026 in April 2020.
"The completion of this Phase 1a study is a major milestone in EicOsis's development of EC5026," says Dr. William K. Schmidt, Vice President of Clinical Development at EicOsis. "We are encouraged by the safety and tolerability of EC5026 in this first-in-human study and look forward to initiating our Phase 1b multiple-ascending dose studies early next year."
EicOsis is planning to start a Phase 1b multiple ascending dose (MAD) clinical trial in healthy volunteers early next year, followed by two nested Phase 1b MAD studies in patients with two chronic pain conditions. The discovery and development of EC5026 by EicOsis and its advancement into clinical trials has been supported in large part by funding from the National Institutes of Health (NIH) through the Blueprint Neurotherapeutics Network (BPN; grant number UH3NS094258-02) and the the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM.
"We are pleased that these Phase One results will enable this agent to move on to the next stage of research, with the ultimate goal of having a therapeutic for some debilitating and devastating pain conditions," said Charles Cywin, Ph.D., BPN Program Director, NINDS, NIH.
Details about the Phase 1 single-ascending dose study can be found in the following link: https://clinicaltrials.gov/ct2/show/NCT04228302.