EicOsis LLC issued the following announcement on Oct. 10.
EicOsis LLC, a pharmaceutical startup developing a new class of oral non-narcotic analgesics, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate Phase 1 clinical trials for their drug candidate, EC5026, for the treatment of pain.
EC5026 (BPN-19186) is a first-in-class, small molecule that potently inhibits soluble Epoxide Hydrolase (sEH), a key regulatory enzyme involved in the metabolism of membrane fatty acids. Inhibition of sEH treats pain by stabilizing natural analgesic and anti-inflammatory mediators. sEH inhibitors developed by EicOsis have already shown efficacy for treating pain with no apparent adverse or addictive effects in laboratory animals and relieving naturally occurring pain in dogs, cats and horses.
"Chronic pain management is a serious public health crisis with few options available that provide effective relief free of life-threatening safety concerns including abuse," says Dr. Scott Fishman, Fullerton Endowed Chair in Pain Medicine, Professor and Director of the Center for Advancing Pain Relief at University of California, Davis School of Medicine. "The medical community is continually seeking effective pain management strategies. EicOsis's new compound is a novel pharmacological approach for treating pain, and I remain optimistic for its success."
Approximately 50 million Americans suffer from chronic pain, according to the Center for Disease Control and Prevention (CDC), with an associated $560 billion yearly cost in medical expenses and lost productivity. Effective and safe options for pain management are currently insufficient.
EicOsis advancement of EC5026 into clinical trials has been funded as part of the Blueprint Neurotherapeutics Network (BPN) of the NIH Blueprint for Neuroscience Research. The BPN is a collaboration of NIH Institutes and Centers that supports innovative research on the nervous system with the goal of developing new neurotherapeutic drugs.
"There is clear unmet need for new pain therapeutics. sEH as an important pain target in our portfolio and we are excited to see EC5026 (BPN-19186) advance to human clinical development on the pathway to treating patients," said Charles L. Cywin, Ph.D., Program Director of BPN.
The development of EC5026 was also supported by funding from the NIH Helping to End Addiction Long-term (HEAL) Initiative to support contract development work. This funding was used to de-risk the development process of EC5026 (BPN-19186) and to accelerate the start of clinical trials.
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