EC5026 for Neuropathic Pain

Overseen By William K Schmidt, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: EicOsis Human Health Inc.

Must not be taking: Opioids, Corticosteroids, RAS-acting drugs, others

Disqualifiers: Ventilator-dependence, Chronic pain, Cardiovascular, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new oral medication, EC5026, to determine its safety and effectiveness in reducing pain for individuals with nerve pain from a spinal cord injury. Participants will take either EC5026 or a placebo (a sugar pill with no active drug) for two weeks. The trial seeks individuals who have had a spinal cord injury for at least a year and experience daily nerve pain unrelieved by at least two types of medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Do I have to stop taking my current medications for the trial?

You may need to stop certain medications before joining the trial. Opioid medications are not allowed, and some other drugs must be at a stable dose for at least a month before the trial. Check with the study team to see if your current medications are permitted.

Is there any evidence suggesting that EC5026 is likely to be safe for humans?

Research has shown that EC5026 is safe in early studies. In these studies, researchers administered single doses of EC5026 to healthy individuals to assess tolerance. Results indicated that EC5026 was generally safe and well-tolerated, with no serious issues reported by participants.

The FDA has granted EC5026 a Fast Track designation, indicating its potential for treating nerve pain and possibly expediting its review process.

Current data suggest EC5026 is safe for humans, but further research is needed to confirm this in individuals with specific conditions like spinal cord injury. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for neuropathic pain, like gabapentin and pregabalin, work by calming overactive nerves through modulation of calcium channels. But EC5026 works differently, targeting a specific enzyme involved in inflammation called soluble epoxide hydrolase (sEH). This unique mechanism may help reduce pain more effectively and with fewer side effects than current options. Researchers are excited about EC5026 because it represents a new approach that could offer relief to patients who don't respond well to existing therapies.

What evidence suggests that EC5026 might be an effective treatment for neuropathic pain?

Research has shown that EC5026, which participants in this trial may receive, could effectively treat nerve pain. Studies have found that it provides strong pain relief in early tests for both nerve and inflammatory pain. EC5026 blocks an enzyme related to pain and swelling, reducing pain without the addiction risk associated with opioids. Early results indicate that EC5026 is safe and well-tolerated in people with pain from spinal cord injuries. This suggests that EC5026 could be a helpful treatment for managing nerve pain. ^{1 2 5 6 7}

Who Is on the Research Team?

William K Schmidt, PhD

Principal Investigator

EicOsis Human Health Inc.

Are You a Good Fit for This Trial?

This trial is for U.S. Veterans aged 18+ with spinal cord injury (SCI) and neuropathic pain lasting over a year. Participants must be in stable health, have no major psychiatric disorders, not use opioids regularly, and agree to contraception if applicable. They should not have significant medical conditions or recent infections, cancer history within 5 years (except nonmetastatic skin cancer), or plans to receive a COVID-19 vaccine during the study.

Inclusion Criteria

I am a US Veteran aged 18 or older.

I have passed a drug test, except for marijuana, and my alcohol level is low.

Subjects must be willing to provide written informed consent to participate in the study

Exclusion Criteria

Subjects with clinically significant abnormalities on screening vital signs, laboratory tests, and/or ECG. Subjects with poor venous access will also be excluded

My pain is not daily or typically nerve-related.

I only experience numbness without any spontaneous pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days. They undergo physical exams, vital signs assessments, ECGs, and blood draws, and complete assessments of pain, sleep, functional status, and perception of change.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including adverse events and changes in pain scores.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EC5026

Trial Overview The trial tests EC5026 against a placebo to see if it's safe and can help manage neuropathic pain from SCI. Patients will take the oral tablet daily for two weeks while undergoing physical exams, ECGs, blood tests, and assessments of their pain levels and overall well-being.

How Is the Trial Designed?

Group I: EC5026 Experimental Treatment 1 Intervention

Multiple oral doses of EC5026

Group II: Placebo Placebo Group 1 Intervention

Matching oral placebo

Who Is Running the Clinical Trial?

EicOsis Human Health Inc.

Lead Sponsor

Trials

5

Recruited

140+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11413051/

Randomized, double‐blind, phase 1a single‐ascending dose ... Our data show that EC5026 produces potent analgesia and a favorable dose–response relationship in multiple preclinical neuropathic pain and inflammatory pain ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7917437/

Movement to the Clinic of Soluble Epoxide Hydrolase Inhibitor ... This report describes the development of an orally active analgesic that resolves inflammation and neuropathic pain without the addictive potential of opioids.

3. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2022.1100524/full

Soluble epoxide hydrolase inhibition alleviates ... The experiments we report use soluble epoxide hydrolase inhibitors (sEHI) which relieved this intractable pain in preclinical models.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211383521003609

Structure-guided discovery of potent and oral soluble ... Oral dosing of A20 at 3 mg/kg/day in the SD rat with neuropathic pain symptom induced by SNI showed a robust increasing of the PWT level, and analgesic effect ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/547475

Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic ... ... EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04228302

Safety, Tolerability, and Pharmacokinetics of Oral EC5026 ... The purpose of the study is to provide initial safety, tolerability, and pharmacokinetics data of single ascending oral doses of EC5026 in healthy subjects.

7. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/EC5026_(drug_in_development).pdf

EC5026 EC5026 is an oral sEH inhibitor developed by EicOsis that inhibits sEH at picomolar concentrations. It is currently in trials for neuropathic pain. One Phase 1a ...