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

Inclusion Criteria:

* Able to read, understand, and sign an informed consent 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
* ACQ-5 score ≥1.25 to ≤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

Exclusion Criteria:

* Recent moderate or severe asthma exacerbation (within 4 weeks before screening)
* History of life-threatening asthma
* Other significant pulmonary disease
* Recent bronchial thermoplasty (within 2 years)
* Uncontrolled current or recurrent concomitant illness
* Recent use of biologic therapies for asthma (within 6 months or 5 half-lives)
* Require immunosuppressive medications or frequent systemic corticosteroids
* Current smokers or former smokers with significant smoking history
* Uncontrolled hypertension
* Significant hepatic impairment