EicOsis Human Health LLC, the Davis-based pharmaceutical company developing a non-narcotic drug to relieve chronic pain and inflammation, today announced the next step in its ongoing human clinical trials: the initiation of Phase 1b to test the safety of its drug candidate, EC5026.
The ongoing double-blind, placebo-controlled Phase 1b study is designed to investigate the safety and pharmacokinetics of daily doses of EC5026 over seven days.
EC5026, an inhibitor of the soluble hydrolase enzyme (sEH), was discovered and patented at EicOsis based on previous patents and research papers from the laboratory of UC Davis distinguished professor Bruce Hammock during his half-century of research.
“EC5026 plays a crucial role in regulating the metabolism of signaling lipids and responding to inflammation and other stress responses caused by trauma or disease,” said Hammock, who holds a joint appointment with the Department of Entomology and Nematology and the UC Davis Comprehensive Cancer Center. “We found sEH to be a target for treating pain, inflammation, cancer and other diseases.”
By inhibiting sEH, EC5026 alleviates pain by preventing the breakdown of natural analgesic and anti-inflammatory fatty acids. Preclinical studies demonstrate no sedation or other adverse behavioral effects and no signs of addiction.
“Many regulatory molecules are controlled as much by degradation as biosynthesis,” Hammock explained. "The epoxy fatty acids rapidly degraded by the sEH control blood pressure, fibrosis,immunity, tissue growth, depression, pain, and inflammation, to name a few processes.”
“The initial results from Cohort 1 appear to replicate the very favorable safety profile we observed in our previous two Phase 1a clinical studies where there were no adverse behavioral, cardiovascular, or neurological effects over five ascending single-dose levels,” said Dr. William Schmidt, EicOsis vice president of clinical development. “The maximum dose level was 5 to 10-fold higher than the anticipated analgesic dose in humans.”
“If Cohort 2 dosing also proceeds without clinically significant adverse effects and a favorable pharmacokinetic profile for once-a-day dosing,” Schmidt continued, “this provides encouragement for initiating our first analgesic efficacy study in the second quarter of 2024.”
EicOsis 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,” said Cindy McReynolds, EicOsis chief executive officer and former director of research.
“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,” said McReynolds, who holds a doctorate in pharmacology and toxicology from UC Davis. “Demonstrating safety in Phase 1b studies will allow us to evaluate efficacy in patients and bring forward safe and effective treatments for several serious diseases. For example, the sEH inhibitors are being considered for use for treatment of cancer in the UC Davis Comprehensive Cancer Center, and neurological disease through the UC Davis Health's designated Parkinson's Foundation Center of Excellence.”
“As a potential anti-inflammatory fatty acid, EC5026 holds promise in addressing neuroinflammation, a key factor in the manifestation and even progression of Parkinson's,” said Zhang, who holds both an M.D. and a PhD. “Ensuring its safety profile in healthy individuals is fundamental for establishing a foundation for further clinical trials. this investigation provides valuable insights into design and overall safety parameters, paving the way for the next stages in advancing this innovative therapeutic approach for Parkinson's disease."
The FDA granted Fast Track status to EC5026 in April 2020 to support the unmet medical need for safe and effective non-opioid analgesics. EicOsis clinical scientist Irene Cortés Puch, who authored the successful application, commented: “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. Therefore, the initiation of this Phase 1b clinical trial is an exciting step in advancing our mission to provide safer and effective treatments.”
Hammock traces his research on chronic pain to his earlier work on how a caterpillar becomes a butterfly; a key enzyme, epoxide hydrolase, degrades a caterpillar's juvenile hormone, resulting in metamorphosis.
A member of the UC Davis faculty since 1980, Hammock founded ;EicOsis in 2011 and served as its chief executive officer until February 2023 when he transitioned to scientific officer and chairman of the board of directors. Highly honored by his peers, he is a member of the National Academy of Inventors and the National Academy of Sciences and received the 2020 Lifetime Achievement Award in Innovation from UC Davis Chancellor Gary May. Hammock has authored or co-authored more than 1400 peer-reviewed publications and holds more than 95 patents in agriculture, environmental science and medicinal chemistry.
EicOsis (pronounced eye-co-sis), derives its name from eicosanoids, “the major backbone of chemical mediators in the arachidonate cascade,” McReynolds said. “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.
More information on the Phase 1b multiple-ascending dose clinical study is available at https://clinicaltrials.gov/study/NCT06089837.
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