APG777 for Asthma

Not currently recruiting at 22 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Apogee Therapeutics, Inc.

Must be taking: Short-acting beta-agonists, Inhaled corticosteroids

Must not be taking: Biologics

Disqualifiers: Life-threatening asthma, Smoking, others

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called APG777, an experimental therapy, to determine its safety and tolerability for individuals with mild-to-moderate asthma. Researchers aim to compare its effects with a placebo, a harmless pill with no active drug, to assess its efficacy. Participants must have had asthma for at least a year, with stable symptoms and no recent severe asthma attacks. The study spans about a year and includes various stages such as screening, treatment, and follow-up. 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 this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that your asthma medications like inhaled corticosteroids or leukotriene receptor antagonists be stable for a certain period before starting the trial.

Is there any evidence suggesting that APG777 is likely to be safe for humans?

Previous studies have shown that APG777 is well tolerated by patients. Research indicates its safety is comparable to other drugs in its category, with no unexpected side effects. One study found that APG777 was safe for humans, reporting no major safety issues over six months. Although APG777 remains under study, these findings suggest it is generally safe for use. However, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for asthma, like inhaled corticosteroids or bronchodilators, work by reducing inflammation or relaxing airway muscles. But APG777 works differently, targeting specific pathways involved in the body's immune response to allergens. Researchers are excited about APG777 because it could offer more precise control of asthma symptoms, potentially leading to fewer side effects and improved quality of life for patients. Unlike traditional treatments, which often require ongoing use, APG777 may provide longer-lasting relief with less frequent dosing.

What evidence suggests that APG777 might be an effective treatment for asthma?

Research has shown that APG777, which participants in this trial may receive, offers promising results for treating asthma. In an earlier study, APG777 met all main goals, indicating high effectiveness. This treatment targets IL-13, a protein that causes inflammation in asthma, potentially making it a strong option for symptom management. Clinical data suggest that APG777 remains active in the body longer than other treatments, which could enhance its effectiveness. These findings provide a solid basis for its potential benefits in managing asthma. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adults with mild-to-moderate asthma are eligible for this study. Specific details about who can join or reasons why someone might be excluded were not provided, so interested individuals should contact the trial organizers for full eligibility criteria.

Inclusion Criteria

Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted normal value at Screening

Asthma Control Test (ACT) score > 19 at Screening

Women of childbearing potential and male participants to use a highly effective form of contraception

Exclusion Criteria

Known history of illicit drug abuse, harmful alcohol use

I have used biologic medications for asthma.

I currently smoke or have smoked a lot in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either APG777 or placebo as per protocol

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• APG777

Trial Overview

The trial is testing APG777 against a placebo to assess its safety and how it's processed by the body (pharmacokinetics) in adults with asthma. Participants will be randomly assigned to either the drug or placebo group and won't know which they're receiving (double-blind).

How Is the Trial Designed?

Group I: APG777 Experimental Treatment 1 Intervention

Participants will receive protocol specified dose of APG7777

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo

Who Is Running the Clinical Trial?

Apogee Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

390+

Published Research Related to This Trial

The study of CAT-354, a human anti-IL-13 antibody, involved 23 adults with asthma and demonstrated a linear pharmacokinetic profile, with a half-life of 12-17 days and low clearance, indicating it can be safely administered in multiple doses.

Most adverse events were mild to moderate and unrelated to the medication, suggesting that CAT-354 has an acceptable safety profile for treating asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma. Singh, D., Kane, B., Molfino, NA., et al.[2021]

In the phase 2b PATHWAY study involving 550 adults with severe, uncontrolled asthma, tezepelumab significantly reduced asthma exacerbations by up to 71% and improved lung function and quality of life compared to placebo.

Tezepelumab treatment led to higher rates of patient-reported outcomes, with up to 82% of patients showing improved asthma control and quality of life, indicating its effectiveness in managing severe asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Corren, J., Garcia Gil, E., Griffiths, JM., et al.[2021]

Citations

1.

investors.apogeetherapeutics.com

investors.apogeetherapeutics.com/news-releases/news-release-details/apogee-therapeutics-announces-positive-16-week-data-phase-2-apex

Release Details - Investor Relations | Apogee Therapeutics, Inc.

Apogee Therapeutics Announces Positive 16-Week Data from Phase 2 APEX Clinical Trial of APG777, its Potentially Best-in-Class Anti-IL-13 ...

2.

investors.apogeetherapeutics.com

investors.apogeetherapeutics.com/news-releases/news-release-details/apogee-therapeutics-provides-pipeline-progress-and-reports-1

Apogee Therapeutics Provides Pipeline Progress and Reports ...

Positive 16-week data from APEX Phase 2 Part A met all primary and key secondary endpoints for APG777, a potentially best-in-class ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06920901

NCT06920901 | A Study to Evaluate the Safety, Tolerability ...

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12419008/

In vitro potency and pharmacokinetics of APG777, a novel ...

Clinical data from a phase 1 study in healthy human volunteers demonstrated that APG777 has a half-life in humans that is 2 to 3 times longer than those of ...

5.

investors.apogeetherapeutics.com

investors.apogeetherapeutics.com/static-files/4829866c-fcd6-45ed-a8ef-fd505b47934c

APEX Phase 2 Part A readout

NOTE: APG777 injections per year based on preliminary PK data and PK simulations. 1 Injections per year in maintenance after an induction ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12589665/

Preclinical Safety of APG777, A Novel Extended Half-Life ...

The safety and efficacy of APG777 are currently being investigated in a Phase 2 clinical trial (NCT06395948) in patients with moderate-to-severe ...

7.

investors.apogeetherapeutics.com

investors.apogeetherapeutics.com/news-releases/news-release-details/apogee-therapeutics-provides-pipeline-progress-and-reports-2

Apogee Therapeutics Provides Pipeline Progress and Reports ...

APG777 was well tolerated with a safety profile consistent with other agents in the class. The Phase 1b trial of APG777 in patients with mild-to ...

8.

annallergy.org

annallergy.org/article/S1081-1206(24)00731-2/fulltext

APG777, ANTI-IL-13 MONOCLONAL ANTIBODY ...

Results of the first study of APG777 in humans, including safety, PK, and PD, are reported through 6 months. Methods. This trial evaluated safety, PK, and PD of ...