• Pipeline Overview
• AEROVANT
• Aeroderm
• Pipeline Development

AEROVANT™ (AER 001, pitrakinra) is a 15 kDa recombinant human protein targeting a receptor that plays a key role in the action of two key cytokines (IL-4 and IL-13) implicated in the pathogenesis of asthma. Aerovance has completed two Phase 2a studies with AEROVANT, demonstrating safety and proof-of-concept activity in patients with mild-to-moderate asthma. The drug will be delivered to the airways in a dry powder formulation using a small, easy to use capsule-based delivery device and the initial clinical target is for the chronic treatment of asthma in adults and children who are not well controlled on inhaled corticosteroids (ICS) or the combination of ICS and long-acting beta2- agonists (LABA).

Mechanism of Action:

AEROVANT is a recombinant dual antagonist of both IL-4 and IL-13 action. IL-4 and IL-13 are the primary cytokines associated with the allergic inflammation and airway hyper-responsiveness of asthma. They are secreted mainly by T helper type 2 (Th2) cells and tend to have some redundancy in signaling due to a shared subunit in their receptor complexes. By inhibiting the activity of both cytokines AEROVANT targets one of the root causes of asthma.

AEROVANT (AER 001)

AER 001 is a human IL-4 mutein that inhibits assembly of IL2Rγ or IL13Rα into receptor complexes with IL-4Rα.

Clinical Development Summary:

Two Phase 2a studies using AEROVANT have been completed, one using subcutaneous administration and one using inhaled (nebulized) administration. Results from both studies showed that AEROVANT markedly reduced the severity of late asthmatic response and was found to be well tolerated. The data were presented at the European Respiratory Society conference in September 2007 and published in October 2007 (The Lancet 2007, 370: 1422-31). The dry powder formulation that will be used in the AEROVANT Phase 2b trial (AeroTrial™) was well tolerated in a Phase 1 study in asthmatics.

Aerovance is developing AEROVANT as a non-steroidal option for treating asthma in moderate to severe asthmatics not well controlled on their current therapies. The company initiated a phase 2b randomized, double-blind, placebo-controlled study of inhaled dry powder AEROVANT in early 2009 to evaluate the ability of AEROVANT to reduce the number of exacerbations in a moderate to severe asthma patient population (n=500). Completion of the study is projected in mid-2010. By using a medication based on a protein occurring naturally in the body, AeroTrial™ seeks a non-steroidal solution to getting control of asthma.