Pipeline Overview
Aerovance is a privately held biopharmaceutical company focused on developing breakthrough medicines for respiratory, allergic and inflammatory diseases. There are currently two lead products in clinical development: AEROVANT™ for moderate to severe asthma is in Phase 2b and Aeroderm™ for eczema is in pre-clinical development. Other clinical stage products in Aerovance’s pipeline include Aerolytic™ for cystic fibrosis (CF) and Pulmolytic™ for chronic obstructive pulmonary disease (COPD).
* A non-PEGylated subcutaneous formulation of Aeroderm (AER 001) successfully completed phase 2a.
Clinical Products:
Aerovance focuses on developing and commercializing biologic molecules primarily for respiratory, allergic and related inflammatory indications that have significant unmet medical needs. With this focus, Aerovance emphasizes novel but validated mechanisms of action, explores related sets of indications, and evaluates new dosage forms and delivery device/product combinations.
AEROVANT
AEROVANT is a first-in-class clinical stage molecule (AER 001) that targets a root cause of asthma by blocking the T helper type 2 (Th2) immune response that causes inflammation in the lungs of asthmatics. In two phase 2a trials, AEROVANT demonstrated a significant reduction in the late asthmatic response (The Lancet 2007, 370: 1422-31). AEROVANT is currently being developed as an inhaled dry powder and has begun a phase 2b trial, AeroTrial, in 500 patients with moderate to severe asthma.
Aeroderm
Aeroderm is a PEGylated, modified form of AER 001 that is in preclinical development. Aeroderm targets a root cause of eczema by inhibiting the abnormal immune response to allergens in patients’ skin. Aeroderm blocks the pro-inflammatory effects of IL-4 and IL-13 through inhibition of their ability to bind to the IL4Rά receptor. In a phase 2a trial where the IL-4/-13 antagonist (AER 001) was administered via subcutaneous injections twice-daily, the treatment group experienced a significant reduction in the number and severity of eczema exacerbations. Aeroderm is currently being developed as a PEGylated molecule for subcutaneous administration for severe uncontrolled eczema, targeting once-weekly to twice-monthly dosing.
Pipeline Development
Aerolytic is a molecule (AER 002) for the treatment of cystic fibrosis (CF) that targets an upstream defect in the pathology of CF lung disease, with the goal of normalizing lung function through its ability to block prostasin, a serine protease that regulates sodium channel activity and mucociliary clearance. Phase 2a results from a 100 patient study in patients living with cystic fibrosis treated with Aerolytic demonstrated that AER 002 was biologically active. Further evaluation is needed to determine the potential for Aerolytic in the treatment of cystic fibrosis.
Pulmolytic is an additional potential indication for Aerolytic for the treatment of chronic obstructive pulmonary disease (COPD). Inhibition of prostasin and the resulting improved mucosal clearance may have therapeutic utility in treating the symptoms of COPD and specifically reducing exacerbations and impeding lung deterioration. Initial proof-of-concept was validated with Aprotinin®, a bovine paralog of Pulmolytic, which increased sputum clearance and improved lung function in chronic bronchitis patients. Exploratory phase 2a results from a 17 patient study in COPD patients treated with Pulmolytic demonstrated that AER 002 was biologically active. Further evaluation is needed to determine the potential for Pulmolytic in the treatment of COPD.