A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of APG777 in Adults With Asthma
Research type
Research Study
Full title
A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma
IRAS ID
1011564
Contact name
Elizabeth Williams
Contact email
Sponsor organisation
Apogee Therapeutics, Inc.
Research summary
Asthma is one of the most common non-communicable diseases affecting an estimated 40 million adults and 12 million children in the United States, France, Germany, Italy, Japan, Spain, and United Kingdom. Asthma is a complex disease driven by genetic and environmental factors that influence airway tone, reactivity, and inflammation. Asthma is a chronic condition which presents most commonly with occasional shortness of breath, chest tightness or pain, and coughing and wheezing.
Treatment for asthma has historically focused on control of symptoms using short- and long-acting inhaled medications (e.g., beta agonists and corticosteroids) as well as reduction of asthma exacerbations though limiting exposures to factors that could precipitate events (e.g., allergens and exercise). Systemic treatments, such as biologics, have been approved for the treatment of moderate-to-severe uncontrolled asthma since the early 2000s with reductions in the annual asthma exacerbation rate of ~50 to 60%; however, these biologics must be injected every 2 to 8 weeks. Despite advances in care, there remains a high unmet medical need for treatment of asthma both in terms of improved efficacy and reduction in injection frequency.
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (how the drug being studied moves throughout the body), and immunogenicity (ability of your body to produce an immune response to the drug) of APG777 in patients with mild-to-moderate asthma. Additionally, results from this study will inform on biomarker response to APG777.
Approximately 32 patients aged 18-65, from the United States and United Kingdom, will take part in this study. Patients will come to the study site for a screening visit, a Treatment visit, and up to 14 follow up visits. Treatment will consist of a single dose of 2 injections given just under the skin of either study drug or placebo, assigned at random.REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0073
Date of REC Opinion
17 Apr 2025
REC opinion
Further Information Favourable Opinion