What is the mechanism of action of this treatment?

Eosinophilic Esophagitis (EoE) is commonly treated through dietary management, proton pump inhibitors (PPIs), topical corticosteroids, and biologics. Dietary management involves eliminating specific allergens to reduce eosinophil infiltration. PPIs reduce acid production, which can decrease eosinophil activity and inflammation. Topical corticosteroids, such as fluticasone or budesonide, are swallowed to directly reduce esophageal inflammation. Biologics, like anti-IL-5 or anti-IL-13 antibodies, target specific pathways in the immune response to reduce eosinophil levels. Zemaira (Alpha-1 Trypsin Inhibitor) is being studied for its potential to inhibit proteases that may contribute to inflammation and tissue damage in EoE. Understanding these mechanisms is crucial for EoE patients as it helps tailor treatments to effectively manage symptoms and prevent long-term esophageal damage.

What side effects are associated with this type of intervention?

Common treatments for Eosinophilic Esophagitis include proton pump inhibitors (PPIs), topical corticosteroids, and dietary management. PPIs can cause side effects such as headache, diarrhea, and abdominal pain. Topical corticosteroids, like fluticasone and budesonide, may lead to oral thrush, hoarseness, and, rarely, adrenal suppression. Dietary management, which involves eliminating specific allergens, generally has fewer side effects but can lead to nutritional deficiencies if not properly managed. Specific side effects of alpha-1 trypsin inhibitors, like Zemaira, are not well-documented in the context of EoE, but they may include injection site reactions and an increased risk of infections.

What prior FDA approvals exist?

The provided context does not mention any specific FDA-approved treatments for Eosinophilic Esophagitis (EoE). However, it does reference a pilot study examining the effects of Zemaira (Alpha-1 Trypsin Inhibitor) in patients with EoE. Other treatments mentioned include Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, which has shown efficacy in a Phase 2 trial for adults with active EoE. No other specific FDA-approved drugs for EoE are detailed in the context.

What other types of research exist?

Promising novel alternatives to Zemaira for Eosinophilic Esophagitis patients include Dupilumab, an IL-4 receptor alpha antagonist, and Tezepelumab, a thymic stromal lymphopoietin (TSLP) inhibitor. Both have shown efficacy in related allergic conditions and are being explored for their potential in treating EoE.

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Proteinase Inhibitor

Alpha-proteinase Inhibitor for Eosinophilic Esophagitis (ZEEPS Trial)

Phase 2

Recruiting

Led By Marc Rothenberg

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Summary

This trial is testing Zemaira, a medication that protects tissues from damage, in patients with Eosinophilic Esophagitis. These patients have chronic inflammation in their esophagus due to an overactive immune response. Zemaira works by blocking harmful enzymes to reduce inflammation and prevent further damage.

Who is the study for?

Adults aged 18-70 with Eosinophilic Esophagitis (EoE) who've had moderate to severe abdominal/chest pain or swallowing difficulties at least twice a week, and whose symptoms weren't controlled by standard treatments. Participants must be willing to maintain their current diet and medical management for EoE throughout the study.

What is being tested?

The trial is testing Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis. It's an open-label study, meaning both researchers and participants know what treatment is being given, focusing on how effective this drug is for treating EoE.

What are the potential side effects?

Potential side effects of Zemaira may include allergic reactions or hypersensitivity following infusion, which could manifest as rash, itching, difficulty breathing, or swelling of the face/lips/tongue/throat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Change in esophageal alpha1 anti-trypsin (A1AT) concentration

Secondary study objectives

Change in serine protease activity

Side effects data

From 2019 Phase 4 trial • 10 Patients • NCT03126370

20%

Renal events deemed possibly, probably or related

100%

80%

60%

40%

20%

Study treatment Arm

TDF With a Boosted PI

TAF With a Boosted PI

TAF With a Boosted PI and LDV/SOF

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active DrugExperimental Treatment1 Intervention

Zemaira alpha-proteinase inhibitor

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Eosinophilic Esophagitis (EoE) is commonly treated through dietary management, proton pump inhibitors (PPIs), topical corticosteroids, and biologics. Dietary management involves eliminating specific allergens to reduce eosinophil infiltration. PPIs reduce acid production, which can decrease eosinophil activity and inflammation. Topical corticosteroids, such as fluticasone or budesonide, are swallowed to directly reduce esophageal inflammation. Biologics, like anti-IL-5 or anti-IL-13 antibodies, target specific pathways in the immune response to reduce eosinophil levels. Zemaira (Alpha-1 Trypsin Inhibitor) is being studied for its potential to inhibit proteases that may contribute to inflammation and tissue damage in EoE. Understanding these mechanisms is crucial for EoE patients as it helps tailor treatments to effectively manage symptoms and prevent long-term esophageal damage.