EC5026 for Parkinson's Disease

(STEP Trial)

Overseen By William K Schmidt, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: EicOsis Human Health Inc.

Must be taking: L-dopa

Must not be taking: Corticosteroids, Chemotherapy, CYP3A4 inducers

Disqualifiers: Atypical parkinsonism, PD psychosis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, EC5026, to determine its safety and effectiveness for people with Parkinson's Disease. Researchers will assess whether the drug targets the correct pathways and measure its levels in the blood and spinal fluid. Participants will take either EC5026 or a placebo daily for 28 days and attend regular checkups. The study seeks adults diagnosed with idiopathic Parkinson's Disease who are stable on their current medication. 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 drug.

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

You can continue taking your current Parkinson's medications like L-dopa, as long as the doses have been stable for at least 30 days before the trial and remain stable during the study. However, you must avoid using any other investigational drugs or certain medications that affect liver enzymes (CYP3A4 inducers or inhibitors) during the trial.

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

Research shows that EC5026 is generally safe for humans. Earlier studies found that this drug targets specific areas without causing safety issues. However, these results come from initial trials with smaller groups. While the findings are encouraging, more research is needed to confirm its safety in larger populations. Participants in the current trial will contribute to understanding its safety and effectiveness in treating Parkinson's Disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

EC5026 is unique because it offers a novel approach to treating Parkinson's disease by potentially targeting inflammation linked to neurodegeneration. Unlike standard treatments like Levodopa or dopamine agonists, which primarily focus on replenishing dopamine, EC5026 might modulate inflammatory pathways. This new mechanism of action could offer symptom relief and possibly slow disease progression, giving researchers hope for improved outcomes for patients.

What evidence suggests that EC5026 might be an effective treatment for Parkinson's Disease?

Research shows that EC5026 targets specific brain areas potentially involved in Parkinson's Disease. It blocks certain enzymes that might contribute to the disease's symptoms. In previous studies, patients treated with enzyme blockers like EC5026 showed improvement in brain swelling and related conditions. The current trial focuses on the safety and efficacy of EC5026 in targeting these brain pathways. Early results suggest it might help reduce Parkinson's symptoms. Ongoing studies aim to confirm these findings and assess EC5026's effectiveness in treating Parkinson's Disease. ^{1 2 4 6 7}

Who Is on the Research Team?

William K Schmidt, PhD

Principal Investigator

EicOsis Human Health Inc.

Lin Zhang, MD, PhD

Principal Investigator

UC Davis Health

Are You a Good Fit for This Trial?

Adults with Parkinson's Disease are eligible for this trial. Participants will take EC5026 or a placebo daily for 28 days and undergo regular clinic visits, blood tests, spinal fluid tests, and questionnaires. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

My Parkinson's is less severe than Stage 3.

Abstention from use of other investigative or non-approved drugs for the duration of the trial

Able to understand the consent form, and to provide voluntary written informed consent

Exclusion Criteria

Participants with difficulty in swallowing oral medications

Clinically significant medical, surgical, or laboratory abnormalities in the judgement of the Investigator

Participants who have used any other investigational drug within 1 month or 5 half-lives, whichever is longer, prior to enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EC5026 or placebo daily for 28 consecutive days

4 weeks

Frequent checkups, blood tests, spinal fluid tests, and questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EC5026

Trial Overview The trial is testing the safety of EC5026, an oral drug candidate for treating Parkinson's Disease. It examines the drug levels in blood and spinal fluid over 28 days of administration and its impact on disease pathways. The study also explores potential symptom improvement compared to a placebo.

How Is the Trial Designed?

Group I: EC5026 4 mg daily Experimental Treatment 1 Intervention

Once-daily, oral dose of 4 mg of EC5026 for 28 consecutive days

Group II: EC5026 2 mg daily Experimental Treatment 1 Intervention

Once-daily, oral dose of 2 mg of EC5026 for 28 consecutive days

Group III: Placebo Placebo Group 1 Intervention

Once-daily, matching placebo for each dose cohort, orally for 28 consecutive days.

Who Is Running the Clinical Trial?

EicOsis Human Health Inc.

Lead Sponsor

Trials

5

Recruited

140+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Trials

117

Recruited

537,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07142044

Safety, Tolerability and Exploratory Efficacy of EC5026 in ... The goal of this clinical trial is to learn if the oral drug candidate EC5026 is safe and targets the correct pathways to treat Parkinson's ...

2. michaeljfox.org michaeljfox.org/grant/assessing-safety-and-efficacy-novel-enzyme-inhibitor-reducing-neuroinflammation-and-enhancing

Assessing the Safety and Efficacy of a Novel Enzyme ... This study will assess the safety, tolerability and efficacy of EC5026 administered at two doses escalated over a 28-day treatment period. Impact on Diagnosis/ ...

3. ctv.veeva.com ctv.veeva.com/study/safety-tolerability-and-exploratory-efficacy-of-ec5026-in-parkinsons-disease-step-study

Safety, Tolerability and Exploratory Efficacy of EC5026 in ... The goal of this clinical trial is to learn if the oral drug candidate EC5026 is safe and targets the correct pathways to treat Parkinson's ...

4. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/parkinsons-disease

Parkinson's Disease clinical trials at University of California ... The goal of this clinical trial is to learn if the oral drug candidate EC5026 is safe and targets the correct pathways to treat Parkinson's ...

5. eicosis.com eicosis.com/about/newsletters/newsletter-2025q1/

EicOsis Quarterly Newsletter April 2025 The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to ...

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

EC5026 Safety: EC5026 is reported to be very selective for its target and an initial clinical trial found no safety concerns. Still, there is no data in large groups ...

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

Randomized, double‐blind, phase 1a single‐ascending dose ... These first‐in‐man clinical studies were designed to evaluate the safety, pharmacokinetics, and food effect of single‐dose exposures of EC5026 in humans.