Table. 2—

Interleukin(IL)-4/IL-13 modulators

CompanyProductMolecular typeIndicationRouteClinical perspective
AerovanceAerovant (AER-001; BAY-16-9996; Pitrakinra)IL-4 variantAsthma (phase II)InhaledPhase III trial in uncontrolled asthmatics is planned
Phase II in atopic asthma (NCT00535028, NCT00535431)
Phase IIb in asthmatics not fully controlled on current therapy (NCT00801853)
AerovanceAeroderm AER-003Pegylated human IL-4 variantAtopic dermatitis (phase II)s.c.Pegylated version of Aerovant
Phase II in atopic dermatitis (NCT00676884) was completed
Amgen; TakedaAMG-317Anti-IL4R mAb (human)Asthma (phase II)Phase II in moderate-to-severe asthma (NCT00436670) : interim results showed biological activity, but clinical efficacy did not meet “expectations” [59]
GenentechMILR1444AAnti-IL-13 mAb (humanised)Asthma (phase II)s.c.Phase II in mild allergic asthma (NCT00781443)
MedImmuneCAT-354Anti-IL-13 mAbAsthma (Phase II)Phase II in moderate-to-severe asthma (NCT00873860)
NovartisQAX576Anti-IL-13 mAbIPF (phase II), asthma (phase I) and rhinitis (phase II)i.v.Phase II in idiopathic pulmonary fibrosis (NCT00843999, NCT00532233, NCT00581997)
Phase II in seasonal allergic rhinitis (NCT00584584)
Phase I/II trial in moderate, persistent allergic asthmatics (NCT00598104) was withdrawn due to the lack of enrolment and complexity of design
Phase I in healthy volunteers (NCT00417196) was completed
WyethAnrukinzumab; IMA-638Anti-IL-13 mAb (humanised)Asthma (phase II)s.c.Phase II in persistent asthma (NCT00425061) was completed
Phase I in mild, atopic asthma (NCT00410280) was completed
Phase I in healthy Japanese subjects (NCT00340327) was completed
Phase I in subjects with asthma (NCT00339872) was completed
ISIS AltairISIS-369645; AIR-645IL-4R antisenseAsthma (phase I) and rhinitis (pre-clinical)Inhaled, weeklyA second-generation antisense inhibitor of IL-4Rα
Phase II trials are expected in 2009, pending positive results from phase I trials (form 10-K, Isis, 2008)
Phase I in healthy subjects and subjects with controlled asthma (NCT 00658749)
WyethIMA-026Anti-IL-13 mAbAsthma (phase I)s.c.; i.v.Phase I in mild, atopic asthma (NCT00725582)
Phase I in healthy Japanese male subjects (NCT00528099)
ApogenixAPG-201IL-4R peptide antagonistCancer
CentocorCNTO-607Anti-IL-13 mAbAsthma
CSL; MerckMK-6105Human anti-IL-13Rα1 mAbAsthma (pre-clinical)
UCBIL-13 mAbIL-13 mAbAsthma (pre-clinical)
Domantis (GSK)DOM-0910Dual anti-IL-4/IL-13 human domain AbAsthmaNo development reported since 2006 (previously undergoing pre-clinical studies)
RegeneronIL-4/IL-13 trapAsthmaNo development reported since 2006 (previously in phase I studies)
SynairgenIL-4/IL-13 inhibitorPeptideAsthma and COPDIt is at the lead optimisation stage [60]
In vitro studies demonstrated inhibition of IL-4 and IL-13
Synairgen is using its proprietary in vivo disease models to demonstrate efficacy of the peptide, which it will then develop and optimise
No development reported since 2007
  • mAb: monoclonal antibody; Ab: antibody; COPD: chronic obstructure pulmonary disease.