EicOsis Human Health has commenced a Phase Ib multiple-ascending dose clinical study of EC5026, the first soluble epoxide hydrolase inhibitor (sEHI) developed for the treatment of pain.
The placebo-controlled, double-blind study aims to assess the safety and pharmacokinetics of the drug candidate, compared to a placebo, over seven days.
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EC5026 is a small molecule drug designed to regulate signalling lipid metabolism and inflammation responses, potentially offering a non-opioid solution for moderate to severe pain management.
Preclinical studies of the drug showed no evidence of sedation, adverse behavioural effects, or addiction.
EicOsis plans to further evaluate the drug’s safety and analgesic properties in pain patients with spinal cord injuries in April this year.
EicOsis CEO Cindy McReynolds said: “Initiation of the Phase Ib programme represents a significant milestone for EicOsis Human Health and demonstrates the success and dedication of our team to make this happen.
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By GlobalData“Demonstrating safety in Phase Ib studies will allow us to evaluate efficacy in patients and bring forward safe and effective treatments for serious disease.”
The company received fast track status from the US Food and Drug Administration for EC5026, highlighting the need for effective non-opioid analgesics.
The development of EC5026 has been supported by the National Institutes of Health (NIH) through various initiatives, including the Small Business Innovation Research (SBIR), the Blueprint Neurotherapeutics Network, and the Helping to End Addiction Long-termSM Initiative (NIH HEAL InitiativeSM).
EicOsis clinical development vice-president Dr William Schmidt said: “The initial results from cohort one appear to replicate the very favourable safety profile we observed in our Phase Ia clinical studies, where there were no adverse behavioural, cardiovascular, or neurological effects over five ascending single-dose levels, and the maximum dose level that was five to ten-fold higher than the anticipated analgesic dose in humans.”
