ENP-501 for people with and without peanut allergy

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ENP-501 in Non-Peanut Allergic Participants and Participants With a Known Peanut Allergy

This trial will test whether ENP-501 is safe and how it affects people aged 14–50 who either have a confirmed peanut allergy or regularly eat peanuts without problems.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 14 Years to 50 Years
• Sex: All
• Sponsor: N-Fold, LLC (Industry-sponsored)
• Drugs / interventions: omalizumab, immunotherapy
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT07117669 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional study gives ENP-501 or placebo to two groups: people with an established peanut allergy and healthy people who regularly eat peanuts and have a negative skin prick test. Participants are aged 14–50, must be medically stable, able to perform spirometry, and agree to avoid peanut for the duration of the study. Safety and clinical activity outcomes will be monitored over the dosing period and follow-up visits. The protocol includes standard safety monitoring and comparisons between the ENP-501 and placebo groups.

Who should consider this trial

Good fit: Ideal candidates are medically healthy people aged 14–50 who can avoid peanuts during the study and either have a confirmed peanut allergy or regularly ingest peanuts without symptoms and have a negative skin prick test for peanut.

Not a fit: People outside the 14–50 age range, those with medical conditions that make them ineligible, those unable to avoid peanuts for the study period, or those who do not meet the allergy/non-allergy cohort definitions are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, ENP-501 could lead to a new option that reduces allergic reactions to peanuts or improves safety for people with peanut allergy.

How similar studies have performed: Other approaches to peanut allergy, such as oral immunotherapy, have shown benefit in prior studies, but ENP-501 is an investigational therapy and its effects are not yet established.

Eligibility criteria

Inclusion Criteria:

Part 1:

* 14-50 years of age (inclusive)
* Otherwise medically healthy and able to participate in the study
* Able to perform spirometry testing in accordance with the American Thoracic Society (ATS) guidelines (2019)
* All women of child-bearing potential, agree to either abstain from sexual activity or agree to use an adequate method of contraception for the duration of the study and for 30 days after the last dose of investigational product
* Signed and dated written informed consent from the participant and/or parent or guardian
* Signed and dated assent from participant under 18 in accordance with local IRB regulations
* Willing and able to avoid peanut and peanut contaminants for the duration of the trial

Part 1 Cohort 1 only (NPA Participants)

* No known clinical history of peanut allergy with regular exposure to peanuts in daily life, i.e ingests peanuts without symptoms
* Negative Skin Prick Test (SPT) (wheal diameter of \<3 mm) to peanut

Part 1 Cohort 2 only (PA Participants)

* A documented clinical history of peanut allergy, which includes the development of symptoms (e.g., urticaria, flushing, rhinorrhea and sneezing, throat tightness or hoarseness, wheezing, vomiting) verified by a physician
* 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®)

Part 2:

* 14 to 50 years of age (inclusive)
* A documented clinical history of peanut allergy, which includes the development of symptoms (e.g., urticaria, flushing, rhinorrhea and sneezing, throat tightness or hoarseness, wheezing, vomiting) verified by a physician
* At least two of the three following requirements at screening:

  1. Positive SPT (wheal diameter of ≥ 3 mm) to peanut
  2. Serum peanut-specific IgE level ≥ 0.7 kUA/L (ImmunoCAP®)
  3. An Ara-h2 IgE level of ≥ 0.5 kUA/L (ImmunoCAP®) within 1 year of enrollment
* Participant must be willing and able to complete a DBPCFC at screening and EOT (24-hours after last dose) 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
* Otherwise medically healthy and able to participate in the study
* Able to perform spirometry testing in accordance with the ATS guidelines (2019)
* All women of child-bearing potential, agree to either abstain from sexual activity or agree to use an adequate method of contraception for the duration of the study and for 30 days after the last dose of investigational product
* Signed and dated written informed consent from the participant and/or parent or guardian
* Signed and dated assent from participant under 18 in accordance with local IRB regulations
* Willing and able to avoid peanut and peanut contaminants for the duration of the trial

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
* Any hospitalization in the past year for asthma, \>1 course of oral steroids for asthma in the past 6 months, or any emergency room visit in the past 6 months for asthma
* Poorly controlled atopic dermatitis
* Eosinophilic gastrointestinal disease
* Use of oral or IV corticosteroids within 30 days of Screening
* Use of tricyclic antidepressants within 6 months of Screening
* Inability to discontinue antihistamines for at least 5 half-lives before skin testing
* Use of omalizumab or other immunomodulatory therapy (not including corticosteroids) or biologic therapy within one year of Screening
* Use of any food allergen-specific or other non-traditional form of allergen immunotherapy within one year of Screening
* Use of immunosuppressive drugs within 30 days of Screening
* Use of ß-blockers (oral)
* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis
* Pregnant or breast-feeding (if female)
* Behavioral, cognitive, or psychiatric disease that in the opinion of the Investigator affects the ability of the participant to understand and cooperate with the study protocol
* Known allergy to inactive ingredients of investigational product (active or placebo)
* Participation in another interventional clinical trial within 30 days of Screening or within 5 half-lives of the other IP
* Residing at the same address as another participant in this or any peanut immunotherapy study

Where this trial is running

Aurora, Colorado

• Research Site 001 — Aurora, Colorado, United States (Recruiting)

Study contacts

• Study coordinator: Balraj Sangha

Conditions Peanut Allergy; Peanut Hypersensitivity