CNP-201 for Peanut Allergy

Recruiting at 17 trial locations

Overseen By Jerry Staser

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: COUR Pharmaceutical Development Company, Inc.

Must not be taking: Th2 inhibitors, β-blockers, Biologics, others

Disqualifiers: Severe anaphylaxis, Severe asthma, Cardiac disease, others

Compensation: Varies

Number of Visits: 6

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment called CNP-201 to see if it is safe and how it affects the body. It includes people who meet specific health criteria. The treatment is given through an IV infusion, and researchers will monitor its safety and effects.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, if you are using certain drugs like Th2 cytokine inhibitors, β-blockers, or angiotensin-converting enzyme inhibitors, you may need to stop them unless your condition is well controlled and the medication won't interfere with the trial. It's best to discuss your specific medications with the trial investigator.

What data supports the effectiveness of the treatment CNP-201 for peanut allergy?

A study on peanut immunotherapy showed that subjects treated with peanut extract had a significant reduction in symptoms and skin test reactivity, indicating potential effectiveness in reducing peanut allergy symptoms. ^{1 2 3 4 5}

What safety data exists for CNP-201 or similar treatments for peanut allergy?

A phase 1 study of a similar treatment, EMP-123, for peanut allergy noted that immunotherapy may be limited by the risk of adverse reactions, indicating potential safety concerns. ^{3 6 7 8 9}

How is the treatment CNP-201 for peanut allergy different from other treatments?

CNP-201 is unique because it may involve a novel approach to allergen-specific immunotherapy (AIT) that could potentially be administered subcutaneously (under the skin), unlike current peanut allergy treatments that are typically given orally. ^{10 11 12 13 14}

Research Team

Jerry Staser

Principal Investigator

COUR Pharmaceuticals

Eligibility Criteria

This trial is for men and women aged 16-55 with a physician-diagnosed peanut allergy or documented history of it. They must weigh at least 31.25 kg, have been on a peanut-free diet for at least 14 days prior to screening, and agree to avoid peanuts during the study. Participants need a specific level of peanut-specific IgE or positive skin test results for peanuts. Women can't be pregnant or breastfeeding, and all participants must use effective contraception.

Inclusion Criteria

Men and non-pregnant women, ages 16 to 55 years inclusive

Subjects who are self-reported to be on a peanut free diet with no suspected peanut exposure, including any peanut food challenge, for at least 14 days prior to Screening and agreement to continue restriction to peanut exposure during the study

Female subjects who agree to not donate ova starting at initial Screening and continuing to Day 60

Exclusion Criteria

You have experienced severe allergic reactions in the past, like difficulty breathing, swelling, or low blood pressure, due to food or medications other than peanuts.

You have a condition called eosinophilic esophagitis or another similar condition affecting your gastrointestinal system.

Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/ antibody as determined at Screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Escalation Phase

Multiple cohorts receive ascending doses of CNP-201 to identify a safe and tolerable dose

8 days

2 visits (in-person)

Expansion Phase

Subjects receive either a safe dose of CNP-201 or Placebo

8 days

2 visits (in-person)

Post-Dosing Follow-up

Participants are monitored for safety and tolerability after dosing

52 days

Multiple visits (in-person)

Double-Blind, Placebo-Controlled Food Challenge

Participants undergo a food challenge to assess response to peanut and placebo

2 days

2 visits (in-person)

Treatment Details

Interventions

• CNP-201

Trial Overview The trial is testing CNP-201 against a placebo in people with peanut allergies over multiple doses to find a safe amount that's tolerable. It has two phases: an Escalation Phase to determine the right dose levels, followed by an Expansion Phase where these levels are tested on more subjects.

Participant Groups

Group I: CNP-201 8 mg Experimental Treatment 1 Intervention

intravenous infusion on Day 1 and Day 8: 8 mg CNP-201

Group II: CNP-201 4 mg Experimental Treatment 1 Intervention

intravenous infusion on Day 1 and Day 8: 4 mg CNP-201

Group III: CNP-201 2 mg Experimental Treatment 1 Intervention

intravenous infusion on Day 1 and Day 8: 2 mg CNP-201

Group IV: CNP-201 1 mg Experimental Treatment 1 Intervention

intravenous infusion on Day 1 and Day 8: 1 mg CNP-201

Group V: Placebo Placebo Group 2 Interventions

200 ml intravenous infusion on Day 1 and Day 8: CNP-201 Placebo

Who Is Running the Clinical Trial?

COUR Pharmaceutical Development Company, Inc.

Lead Sponsor

Trials

7

Recruited

250+

Findings from Research

Peanut allergy is increasingly common in children, particularly in developed countries, and while the exact reasons for this rise are unclear, it is a significant health concern that requires careful management.

Recent trials of peanut oral immunotherapy (OIT) have shown promise in desensitizing individuals to peanuts, offering a potential treatment option, although there is currently no cure for peanut allergy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peanut allergy. Pansare, M., Kamat, D.[2015]

In a phase 1 trial involving 15 participants (5 healthy adults and 10 peanut-allergic adults), the rectal administration of the modified peanut protein vaccine EMP-123 showed no significant adverse effects in healthy volunteers, but 50% of peanut-allergic subjects experienced adverse reactions, including severe allergic reactions in 20%.

Despite the adverse reactions, the treatment led to significant reductions in peanut skin test responses and basophil activation, indicating some immunologic effects, although no significant changes were observed in total IgE or peanut-specific IgE levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 study of heat/phenol-killed, E. coli-encapsulated, recombinant modified peanut proteins Ara h 1, Ara h 2, and Ara h 3 (EMP-123) for the treatment of peanut allergy. Wood, RA., Sicherer, SH., Burks, AW., et al.[2021]

The covalent heterobivalent inhibitor (cHBI) effectively prevented peanut allergy reactions in a humanized mouse model for over 2 weeks after administration before allergen exposure, demonstrating its potential as a preventive therapy.

cHBI not only prevented severe allergic reactions but also reduced symptoms and prevented fatal anaphylaxis when given shortly after symptoms began, indicating its efficacy in managing peanut-induced allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peanut allergen inhibition prevents anaphylaxis in a humanized mouse model. Alakhras, NS., Shin, J., Smith, SA., et al.[2023]

Peanut and tree nut allergies are common in children, often starting in early childhood, and they tend to persist, leading to severe allergic reactions that can be life-threatening.

The review highlights recent advancements in understanding the genetic basis and immunological characteristics of these allergies, as well as new treatment options being explored in animal models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peanut and tree nut allergy. Sicherer, SH., Sampson, HA.[2019]

In a study of 67 patients allergic to lipid transfer protein (LTP), 27% developed new food allergies over 1 to 16 years, primarily to Rosaceae/Prunoideae, tree nuts, and peanuts.

Patients who were monosensitized to LTP experienced more severe systemic reactions compared to those with additional sensitizations, highlighting the need for careful dietary management and monitoring for new allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergy to LTP: to eat or not to eat sensitizing foods? A follow-up study. Asero, R., Piantanida, M., Pravettoni, V.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Early clinical predictors of remission of peanut allergy in children. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of peanut allergy with rush immunotherapy. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Successful oral tolerance induction in severe peanut allergy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Peanut allergy. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnosis of Peanut Allergy in Preschool Children: The Impact of Skin Testing With a Novel Composition of Peanuts. [2021]

6. Denmark pubmed.ncbi.nlm.nih.gov

A phase 1 study of heat/phenol-killed, E. coli-encapsulated, recombinant modified peanut proteins Ara h 1, Ara h 2, and Ara h 3 (EMP-123) for the treatment of peanut allergy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Peanut allergen inhibition prevents anaphylaxis in a humanized mouse model. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The importance of dietary control in the development of a peanut allergy model in Brown Norway rats. [2015]

10. Switzerland pubmed.ncbi.nlm.nih.gov

From Allergen Molecules to Molecular Immunotherapy of Nut Allergy: A Hard Nut to Crack. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Peanut and tree nut allergy. [2019]

12. Italy pubmed.ncbi.nlm.nih.gov

Allergy to LTP: to eat or not to eat sensitizing foods? A follow-up study. [2019]

13. Denmark pubmed.ncbi.nlm.nih.gov

Effects of a pre-existing food allergy on the oral introduction of food proteins: findings from a murine model. [2014]

14. United States pubmed.ncbi.nlm.nih.gov

Elimination diet and the development of multiple tree-nut allergies. [2018]