Aeroderm
Aeroderm™, a PEGylated mutein of AEROVANT, is being developed as a once-weekly to twice-monthly subcutaneous injectable treatment for patients diagnosed with severe eczema. Aeroderm, like AEROVANT, is a recombinant human protein that is a potent inhibitor of the IL-4 and IL-13 activity. IL-4 and IL-13 are the primary cytokines associated with persistent allergic inflammation present in severe eczema, and 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 IL-4 and IL-13, Aeroderm targets one of the root causes of eczema.
AEROVANT (AER 003)
Aeroderm (AER 003) is a PEGylated variant of AER 001, a human IL-4 mutein that inhibits assembly of IL2Rγ or IL13Rα into receptor complexes with IL-4Rα
Clinical Development Summary:
Aerovance has completed a randomized, double-blind Phase 2a trial of AER 001 (AEROVANT) in 25 patients (14 on placebo and 11 on drug) with moderate to severe eczema. 30 mg of AER 001 or placebo was administered via subcutaneous injection twice daily for 28 days with the primary endpoint of reduction in the EASI (Eczema Area and Severity Index) score, a validated measure of disease severity.
The study demonstrated that treatment with AER 001 led to a significant reduction in EASI score in the AER 001 group following 4 weeks of treatment. The trend toward improvement with AER 001 but not placebo was evident by 2 weeks of treatment (AER 001: p=0.064, 9.2-point reduction from baseline; placebo: p = 0.935, 2.3-point reduction from baseline). There were also statistically significantly fewer exacerbation days (eczema-related adverse events, p<0.001) and improvements in relevant immune biomarkers (IgE [p=0.003], and peripheral lymphocytes). AER 001 was well tolerated in this study.
Future studies will evaluate the efficacy and safety of the PEGylated longer acting molecule, Aeroderm, (AER 003) in moderate to severe patients living with eczema.