ENP-501 for Peanut Allergy

Overseen By Balraj Sangha

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: N-Fold, LLC

Must not be taking: Tricyclics, Immunosuppressants, ß-blockers, others

Disqualifiers: Severe anaphylaxis, Asthma, Atopic dermatitis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ENP-501 to determine its safety and effectiveness for people with peanut allergies. It includes both individuals with a peanut allergy and those without, assessing their reactions to the treatment or a placebo (a harmless, inactive substance). Ideal participants either regularly consume peanuts without an allergic reaction or have a doctor-verified peanut allergy with symptoms such as sneezing or throat tightness. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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

Yes, you may need to stop certain medications. The trial excludes participants using oral or IV corticosteroids, tricyclic antidepressants, antihistamines, omalizumab, other immunomodulatory therapies, biologic therapies, immunosuppressive drugs, and ß-blockers. Please consult with the trial team for specific guidance on your medications.

Is there any evidence suggesting that ENP-501 is likely to be safe for humans?

Research has shown that ENP-501 is being tested for safety in individuals with and without peanut allergies. As an early trial, the primary goal is to assess how well participants tolerate this treatment. In these studies, ENP-501 has shown promise, but researchers continue to monitor it for any side effects or problems.

As a Phase 1/2 study, this marks one of the first times ENP-501 is tested in humans, so scientists are still learning about its effects. At this stage, the focus remains on safety. So far, no detailed reports of serious issues have emerged, but more information is needed for certainty.

Early trials like this aim to identify potential safety concerns before testing on larger groups. Considering participation offers a chance to contribute to important research while being closely monitored by experts. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for peanut allergies, which often includes avoidance of peanuts and the use of antihistamines or epinephrine for reactions, ENP-501 offers a new approach. This treatment is exciting because it uses a novel mechanism that aims to desensitize the immune system to peanuts, potentially reducing allergic reactions significantly. Researchers are particularly interested in ENP-501's ability to potentially provide long-term relief from peanut allergies, which could improve the quality of life for many sufferers.

What evidence suggests that ENP-501 might be an effective treatment for peanut allergy?

Research shows that ENP-501, which participants in this trial may receive, is being tested to help people with peanut allergies. Although detailed information from human studies remains limited, this treatment aims to help the body handle peanuts better. It might help people with peanut allergies experience milder reactions upon contact with peanuts. Similar treatments have shown promise in reducing the severity of allergic reactions, especially in controlled studies. Early results suggest that ENP-501 could effectively lessen allergic reactions, but further research is needed for confirmation. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with a peanut allergy. Specific criteria will determine eligibility, but the main requirements are not provided in the given information.

Inclusion Criteria

Willing and able to avoid peanut and peanut contaminants for the duration of the trial

For Part 1 Cohort 2 (PA Participants): A documented clinical history of peanut allergy with symptoms verified by a physician and at least two of the three following requirements: 1. Positive Skin Prick Test (SPT) (wheal diameter of ≥8 mm) to peanut, 2. An elevated serum peanut specific IgE level ≥7 kUA/L (ImmunoCAP®), 3. An Ara-h2 IgE level of ≥2 kUA/L (ImmunoCAP®)

For Part 2: A documented clinical history of peanut allergy with symptoms verified by a physician, at least two of the three specified requirements at screening, willingness and ability to complete a DBPCFC, and experience dose-limiting symptoms at or before the 300 mg challenge dose of peanut protein during a Double Blind, Placebo Controlled Food Challenge (DBPCFC) conducted in accordance with Practical Issues in Allergology, Joint United States/European Union Initiative (PRACTALL) guidelines

Exclusion Criteria

History of severe anaphylactic event requiring mechanical ventilation or use of intravenous (IV) vasopressor drugs

Clinically significant screening electrocardiogram (ECG) abnormality or corrected QTcF >/= 450 msec at Screening

FEV1 value < 80% predicted at Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ENP-501 or placebo to evaluate safety and clinical activity

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ENP-501

Trial Overview The study is testing ENP-501, a potential treatment for peanut allergies, against a placebo. It aims to assess safety and effectiveness in both non-allergic and allergic participants.

How Is the Trial Designed?

Group I: ENP-501 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

N-Fold, LLC

Lead Sponsor

CBCC Global Research

Collaborator

Trials

8

Recruited

1,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07117669?aggFilters=status:,phase:2

Study of ENP-501 in Peanut-Allergic and Non- ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a ...

2. withpower.com withpower.com/trial/phase-2-peanut-hypersensitivity-7-2025-93ffe

ENP-501 for Peanut Allergy · Info for Participants It aims to assess safety and effectiveness in both non-allergic and allergic participants. How Is the Trial Designed?

3. ctv.veeva.com ctv.veeva.com/study/study-of-enp-501-in-peanut-allergic-and-non-allergic-participants

Study of ENP-501 in Peanut-Allergic and Non-Allergic ... This is a Phase 1/2 study to evaluate the safety and clinical activity of ENP-501 in non-peanut allergic (NPA) healthy participants and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12511798/

Immunotherapy in Peanut Allergy: The Present and ... In the PEPITES trial involving children aged 4–11 years, EPIT for 12 months resulted in improved desensitization to oral peanut challenge ...

5. withpower.com withpower.com/clinical-trials/for-peanut-allergy

Top Peanut Allergy Clinical Trials | Power This trial is testing a treatment to see if it can help adults with peanut allergies tolerate peanuts better. People involved in the study will take the ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0001825

Peanut Hypersensitivity (DBCOND0001825) The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy ... Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants.

7. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07117669

ENP-501 in Peanut Allergy - Clinical Trials Registry - ICH GCP This is a Phase 1/2 study to evaluate the safety and clinical activity of ENP-501 in non-peanut allergic (NPA) healthy participants and ...