EicOsis Initiates Phase 1b Clinical Trial of EC5026

EC5026 is the first soluble epoxide hydrolase inhibitor (sEHI) developed to treat pain

DAVIS, Calif., Jan. 30, 2024 /PRNewswire/ -- EicOsis Human Health, a pharmaceutical company engaged in the development of a novel category of non-narcotic oral analgesics centered around the inhibition of the soluble epoxide hydrolase (sEH) enzyme, today announced the next step in its ongoing human clinical trials: the initiation of Phase 1b multiple-ascending dose clinical trial to test the safety of its drug candidate, EC5026.

The double-blind, placebo-controlled Phase 1b study is designed to investigate the safety and pharmacokinetics of daily doses of EC5026 or placebo over seven days. Initial results show no apparent changes in vital signs, behavior effects, or clinically significant adverse effects in any subjects.

EC5026, a small molecule drug that is a potent and highly selective inhibitor of the sEH enzyme, plays a crucial role in regulating the metabolism of signaling lipids and responding to inflammation and other stress responses caused by trauma or disease. By inhibiting sEH, EC5026 alleviates pain by preventing the breakdown of natural analgesic and anti-inflammatory fatty acids, which represents a potential non-opioid approach to treat moderate to severe pain. Preclinical studies demonstrate no sedation or other adverse behavioral effects and no signs of addiction.

UC Davis distinguished professor and founder of EicOsis, Bruce Hammock, who holds a joint appointment with the Department of Entomology and the UC Davis Comprehensive Cancer Center, discovered the enzyme inhibitor. "Many regulatory molecules are controlled as much by degradation as biosynthesis," Hammock explained. "The epoxy fatty acids rapidly degraded by the sEH regulate inflammation and control pain, fibrosis, depression, and neuroinflammation, to name a few processes."

Dr. William K Schmidt, Vice President of Clinical Development at EicOsis, expressed optimism about the Phase 1b study and emphasized the promising safety and tolerability profile of EC5026. "The initial results from cohort 1 appear to replicate the very favorable safety profile we observed in our Phase 1a clinical studies where there were no adverse behavioral, cardiovascular, or neurological effects over five ascending single-dose levels and the maximum dose level that was 5 to 10-fold higher than the anticipated analgesic dose in humans."

EicOsis is developing an sEH inhibitor EC5026 to treat pain and inflammation in multiple conditions and plans to initiate its first pain patient study in April 2024 to evaluate safety and analgesic effects in patients with a spinal cord injury who have failed to achieve satisfactory pain relief with existing non-opioid chronic pain medications. The FDA granted Fast Track status to EC5026 due to the unmet medical need for safe and effective non-opioid analgesics.

"Initiation of the Phase 1b program represents a significant milestone for EicOsis Human Health and demonstrates the success and dedication of our team to make this happen. Demonstrating safety in Phase 1b studies will allow us to evaluate efficacy in patients and bring forward safe and effective treatments for serious disease," said Cindy McReynolds, Chief Executive Officer of EicOsis.

The National Institutes of Health (NIH) supported the progression of EC5026 into clinical trials through the Small Business Innovation Research (SBIR), Blueprint Neurotherapeutics Network and the Helping to End Addiction Long-termSM Initiative (NIH HEAL InitiativeSM).

'Both our commitment and focus at EicOsis Human Health are guided by a genuine concern for the well-being of patients and recognizing the importance of identifying effective pain management alternatives," commented EicOsis clinical scientist Irene Cortes-Puch. "Therefore, the initiation of this Phase 1b clinical trial is an exciting step in advancing our mission to provide safer and effective treatments."

EicOsis (pronounced eye-co-sis), derives its name from eicosanoids, "the major backbone of chemical mediators in the arachidonate cascade," said McReynolds. "It symbolizes the epoxide group in chemistry, which is key to the anti-inflammatory chemical mediators and where the biochemical target called soluble epoxide hydrolase works."

Approximately 50 million Americans (20 percent of the population) suffer from chronic pain, according to the Centers for Disease Control and Prevention. The annual economic toll is $560 billion, encompassing direct medical expenses, lost productivity, and disability claims.

Phase 1b multiple-ascending dose clinical study details can be found in the following link: https://clinicaltrials.gov/study/NCT06089837.

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SOURCE EicOsis