ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults

Who May Qualify: - Able to read, understand, and sign an willing to sign a consent form form before any study procedures. - Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months. - Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening. - Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline. - Demonstrated bronchodilator reversibility, defined as ≥12% and ≥200 mL improvement in FEV₁ (or ≥20% increase in peak expiratory flow) after short-acting bronchodilator use. - ACQ-5 score ≥1.25 and ≤3.0 at screening and baseline. - History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care. Who Should NOT Join This Trial: - Had a moderate or severe asthma exacerbation within 4 weeks before screening. - Have a history of life-threatening asthma, including intubation or respiratory arrest. - Have any other significant pulmonary disease (e.g., COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, tuberculosis, lung cancer, or eosinophilic syndromes). - Had bronchial thermoplasty within 2 years before screening. - Used biologic therapies for asthma (e.g., benralizumab, mepolizumab, reslizumab, omalizumab, dupilumab, or tezepelumab) within 6 months or 5 half-lives prior to baseline. - Require immunosuppressive medications or frequent systemic corticosteroids (more than 3 courses in the past 6 months). - Are current smokers or former smokers with \>10 pack-year history or who quit within 6 months before screening. - Have uncontrolled hypertension (systolic ≥160 mmHg or diastolic \>95 mmHg). - Have significant hepatic impairment or any other condition that, in the investigator's opinion, would interfere with study participation or interpretation of results. Always talk to your doctor about whether this trial is right for you.