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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called CNP-201 for individuals with peanut allergies. Researchers aim to determine the safety of CNP-201 and how the body processes various doses. Participants will receive either the treatment or a placebo (a harmless substance with no therapeutic effect) through an intravenous infusion. This study suits those with a documented history of peanut allergies who have experienced mild allergic reactions, such as mild wheezing. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that CNP-201 is likely to be safe for humans?

Research has shown that CNP-201 is being tested for safety in individuals with peanut allergies. This early-stage trial examines how well participants tolerate different doses. Such trials typically involve small groups to gather initial safety data.

Detailed safety information remains limited because this is among the first uses of CNP-201 in humans. However, early trials are carefully designed to monitor side effects and ensure safety. If participants tolerate these initial doses well, researchers will test CNP-201 with larger groups.

In summary, the trial closely monitors the safety of CNP-201 and aims to identify a dose that participants can tolerate without major issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peanut allergy?

Researchers are excited about CNP-201 for peanut allergies because it offers a new approach to treatment. Unlike traditional methods such as oral immunotherapy or avoidance strategies, CNP-201 is an intravenous infusion that might provide a quicker and potentially more convenient way to desensitize patients to peanuts. This treatment targets the immune system directly, possibly leading to faster and more effective protection against allergic reactions.

What evidence suggests that CNP-201 might be an effective treatment for peanut allergy?

Research shows that CNP-201 is being explored as a potential treatment for peanut allergies. This trial will test various dosages of CNP-201, including 1 mg, 2 mg, 4 mg, and 8 mg, to evaluate its effectiveness in altering the immune system's response to peanuts, which can trigger allergic reactions. Early results suggest that CNP-201 might reduce the severity of these reactions. Although limited data from human trials exist, similar treatments have shown promise in managing food allergies. Scientists remain hopeful that CNP-201 could offer a new solution for individuals with peanut allergies. ^{1 2 3 5 6}

Who Is on the Research Team?

Jerry Staser

Principal Investigator

COUR Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05250856

NCT05250856 | CNP-201 in Subjects With Peanut Allergy This study is a Phase 1b/2a clinical trial to assess the safety, tolerability, and pharmacodynamics of multiple ascending doses (Escalation Phase) of ...

2. trials.foodallergy.org trials.foodallergy.org/trials/NCT05250856

CNP-201 in Subjects With Peanut Allergy - Clinical Trial Finder Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety ...

3. withpower.com withpower.com/trial/phase-2-hypersensitivity-2-2022-7962a

CNP-201 for Peanut Allergy · Info for Participants 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.

4. prnewswire.com prnewswire.com/news-releases/cour-pharmaceuticals-announces-first-in-human-dosing-in-proof-of-concept-trial-of-cnp-201-to-treat-peanut-allergy-301403393.html

COUR Pharmaceuticals Announces First in Human Dosing ... The trial will evaluate the safety and efficacy of CNP-201 in people ages 16 to 55 with peanut allergy and is led by Kari Nadeau, M.D., Ph. D., ...

5. ctv.veeva.com ctv.veeva.com/study/cnp-201-in-subjects-with-peanut-allergy

CNP-201 in Subjects With Peanut Allergy - ClinicalTrials.Veeva This study is a Phase 1b/2a clinical trial to assess the safety, tolerability, and pharmacodynamics of multiple ascending doses (Escalation ...

6. firstwordpharma.com firstwordpharma.com/story/5422865

COUR Pharmaceuticals Announces First in Human Dosing ... CHICAGO, Oct. ... The trial will evaluate the safety and efficacy of CNP-201 in people ages 16 to 55 with peanut allergy and is led by Kari Nadeau ...