On February 5, Advagene Biopharma, a biotech company listed on the Emerging Stock Market, announced that its investigational nasal spray therapy AD17002 for severe asthma has successfully met its safety and efficacy endpoints in an exploratory Phase II clinical trial. The trial results demonstrate significant improvements in lung function, reduced inflammation, and decreased eosinophil levels in both blood and sputum. These findings will be presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in early March.
According to Dr. Yu Shen Hsu, CEO of Advagene Biopharma, the Phase II exploratory clinical trial of AD17002 was led by Dr. Han-Pin Kuo, a distinguished pulmonologist and professor at Taipei Medical University, specializing in asthma research and treatment. The study focused on patients with uncontrolled moderate-to-severe eosinophilic asthma, aiming to explore the drug’s underlying mechanisms and verify its therapeutic potential.
The trial enrolled 16 patients, who were divided into three dosage groups and self-administered the nasal spray twice weekly for five consecutive weeks. Following more than a year of follow-up observations, the results confirmed that AD17002 met expectations for both safety and efficacy.
In terms of efficacy, patients treated with AD17002 showed improvements in forced expiratory volume in one second (FEV1), with a peak improvement of approximately 260 mL, indicating better lung function. In addition, biomarkers associated with airway inflammation, such as fractional exhaled nitric oxide (FeNO), IL-4, and IL-5, were significantly reduced, further confirming the drug’s anti-inflammatory effects.
Eosinophil levels—a key indicator for diagnosing severe asthma and assessing prognosis—were also evaluated in both blood and sputum samples. The results showed that AD17002 treatment led to a 36% reduction in blood eosinophils and a 16.25% reduction in sputum eosinophils, whereas the placebo group showed no significant improvement.
Dr. Hsu emphasized that asthma is a chronic inflammatory respiratory disease that severely impacts patients' quality of life, often causing chest tightness, shortness of breath, and difficulty breathing. The primary treatment for asthma involves inhaled corticosteroids (ICS) to control symptoms and prevent exacerbations. However, patients with severe asthma often fail to achieve adequate disease control with ICS alone and may face persistent risks of acute exacerbations and permanent lung function decline. Given this, the positive results from AD17002’s exploratory Phase II clinical trial mark a significant breakthrough.
AD17002 is an immune-modulating protein therapy developed using Advagene Biopharma’s proprietary detoxified LTh(αK) technology platform. It is also one of the few innovative nasal spray-based protein drugs currently in development worldwide. The therapy works by inducing interferon type I production in airway epithelial cells, thereby regulating multiple inflammatory factors, including eosinophils. The promising outcomes from this Phase II clinical trial, led by Dr. Kuo, suggest that AD17002 can effectively control and improve moderate-to-severe eosinophilic asthma. Encouraged by these results, Advagene Biopharma plans to advance to the next stage of development, with a New Drug Application (NDA)-ready Phase II trial scheduled for mid-2025. The company aims to expand the trial through a multi-center study to strengthen the reliability of its clinical data and accelerate market approval, ultimately providing patients with a more effective and convenient treatment option.
Asthma prevalence continues to rise globally despite advancements in healthcare and hygiene, affecting an estimated 350 million people worldwide. Data suggests that one in five asthma patients struggles with inadequate disease control, contributing to over 400,000 asthma-related deaths annually and placing a significant financial burden on healthcare systems. At the same time, the asthma treatment market presents a substantial opportunity. According to a Value Market Research (VMR) report, the global asthma treatment market, valued at $32.08 billion in 2023, is projected to reach approximately $53.47 billion by 2032, with a compound annual growth rate (CAGR) of 5.84%.
Resource: 昱厚生技嚴重氣喘鼻噴新藥 探索性二期臨床數據達標
