DAVIS--EicOsis LLC, a newly formed company that distinguished professor Bruce Hammock of the University of California, Davis, founded to alleviate neuropathic and inflammatory pain, has received a $4 million federal grant to advance his compound discovery through Phase 1 clinical trials.

The grant, “Development of an Oral Analgesic for Neuropathic Pain," is funded by the  Blueprint for Neuroscience Research. National Institutes of Health (NIH).

The clinical trials, scheduled to begin in 2017, will target diabetic neuropathic pain, occurring in an estimated half of the world's 347 million diabetics, and 29 million Americans.

The compound “is an inhibitor of the soluble epoxide hydrolase (sEH) enzyme,” said Hammock, whose fundamental research on the developmental biology of insects led to the discovery. “It is a key regulatory enzyme involved in the metabolism of fatty acids and treats pain by stabilizing natural analgesic and anti-inflammatory mediators.”

Now known as EC5026, the compound is “a potent, orally active and a non-narcotic analgesic that does not adversely affect the brain, gastrointestinal tract, or cardiovascular system,” said Alan Buckpitt, the company's vice president of pharmacology and emeritus professor of molecular biosciences at the UC Davis School of Veterinary Medicine. “The compound effectively treats pain in preclinical models at low oral doses with no apparent adverse or addictive effects. Preclinical studies demonstrate efficacy that exceeds current therapies for diabetic neuropathy.”

“We are really honored to have been the first company to enter directly into the clinical development phase of the NIH Blueprint Neurotherapeutics Network award program,” said William Schmidt, EicOsis vice president of clinical development. “Since this was a highly competitive grant, this demonstrates the enthusiasm that the NIH has for developing non-opioid therapeutic options for treating severe pain.  With the support and direct collaboration of outside experts in the NIH network, we look forward to advancing this novel type of analgesic drug into human clinical trials.”

Diabetes, increasing at global epidemic levels, is traced to rising obesity and physical inactivity. While 29 million Americans have diabetes, an estimated 86 million are pre-diabetic. The complex disease can lead vision loss, heart disease, stroke, and other debilitating medical conditions.

Current therapies for diabetic neuropathy pain are ineffective in more than three of four patients. “The EicOsis technology may solve a great need in pain treatment in providing a powerful analgesic which avoids the side effects of opioids (narcotics) and nonsteroidal anti-inflammatory drugs (NSAIDs),” said physician Scott Fishman, professor and chief of the Division of Pain Medicine, UC Davis Health System, who is not affiliated with the company. “The EicOsis compound holds great promise for controlling neuropathic pain in general and particularly for this difficult and common medical problem.”

Hammock said EC5026 and close analogs have already shown to be effective “against naturally-occurring moderate-to-severe pain in dogs, cats, and horses.” 

A goal of the Blueprint Neurotherapeutics Network is to discover, develop and generate novel compounds that will ultimately be commercialized and benefit humankind.

The $4 million grant will provide both financial support and shared resources for advancing the EicOsis compound through early clinical trials. The Blueprint for Neuroscience Research is a cooperative effort among the 15 NIH Institutes, centers and offices that support neuroscience research and accelerates discoveries through pooled resources and expertise.

“The Blueprint program provides a team with decades of experience in fields ranging from formulation to registration,” said Peppi Prasit, CEO of Inception Sciences and an EicOsis advisor. “This depth is an enormous help to a small company.  Blueprint pays for the big ticket items along the path through Phase 1 clinical trials.  The ability to leverage this intellectual and financial support will make EicOsis an attractive investment.”

"The Blueprint has funded early drug development efforts in the past, but EicOsis is the first group in the nation to be funded in their advanced development phase," said EicOsis project manager Cindy McReynolds, program manager of the Hammock lab in the UC Davis Department of Entomology and Nematology.  

EicOsis (pronounced eye-cosis), is described on its website, http://www.eicosis.com/, as a privately held Davis-based company developing a first-in-class therapy of a once daily, oral treatment for neuropathic and inflammatory pain in humans and companion animals. Hammock developed the technology for the lead compound. UC Davis licensed the compound exclusively to EicOsis. The company maintains a strong patent position with both method-of-use and composition-of-matter patents.

Research was supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number UH2NS094258.

Much of the research was supported through the UC Davis Department of Entomology by the NIH, National Institute of Environmental Health Sciences (NIEHS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the American Asthma Society.

Hammock is a fellow of the National Academy of Inventors, which honors academic invention and encourages translations of inventions to benefit society. He is a member of the U.S. National Academy of Sciences, a fellow of the Entomological Society of America, and the recipient of the Bernard B. Brodie Award in Drug Metabolism, sponsored by the America Society for Pharmacology and  Experimental Therapeutics. He directs the campuswide Superfund Research Program, National Institutes of Health Biotechnology Training Program, and the National Institute of Environmental Health Sciences (NIEHS) Combined Analytical Laboratory.

A member of the UC Davis faculty since 1980, Hammock received his bachelor of science degree magna cum laude from Louisiana State University in entomology and chemistry, and his doctorate from UC Berkeley in entomology and toxicology, working in xenobiotic metabolism. (For biographies on the other EicOsis officers, see website on EicOsis personnel.)

For more information, access the website at http://www.eicosis.com or contact project managere Cindy McReynolds at  cbmcreynolds@eicosis.com or 530-341-4194.

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