Table. 2—

Interleukin(IL)-4/IL-13 modulators

Company	Product	Molecular type	Indication	Route	Clinical perspective
Aerovance	Aerovant (AER-001; BAY-16-9996; Pitrakinra)	IL-4 variant	Asthma (phase II)	Inhaled	Phase 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)
Aerovance	Aeroderm AER-003	Pegylated human IL-4 variant	Atopic dermatitis (phase II)	s.c.	Pegylated version of Aerovant
					Phase II in atopic dermatitis (NCT00676884) was completed
Amgen; Takeda	AMG-317	Anti-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]
Genentech	MILR1444A	Anti-IL-13 mAb (humanised)	Asthma (phase II)	s.c.	Phase II in mild allergic asthma (NCT00781443)
MedImmune	CAT-354	Anti-IL-13 mAb	Asthma (Phase II)		Phase II in moderate-to-severe asthma (NCT00873860)
Novartis	QAX576	Anti-IL-13 mAb	IPF (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					Phase I/II trial in moderate, persistent allergic asthmatics (NCT00598104) was withdrawn due to the lack of enrolment and complexity of design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
Wyeth	Anrukinzumab; IMA-638	Anti-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 Altair	ISIS-369645; AIR-645	IL-4R antisense	Asthma (phase I) and rhinitis (pre-clinical)	Inhaled, weekly	A 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)
Wyeth	IMA-026	Anti-IL-13 mAb	Asthma (phase I)	s.c.; i.v.	Phase I in mild, atopic asthma (NCT00725582)
					Phase I in healthy Japanese male subjects (NCT00528099)
Apogenix	APG-201	IL-4R peptide antagonist	Cancer
Centocor	CNTO-607	Anti-IL-13 mAb	Asthma
CSL; Merck	MK-6105	Human anti-IL-13Rα1 mAb	Asthma (pre-clinical)
UCB	IL-13 mAb	IL-13 mAb	Asthma (pre-clinical)
Domantis (GSK)	DOM-0910	Dual anti-IL-4/IL-13 human domain Ab	Asthma		No development reported since 2006 (previously undergoing pre-clinical studies)
Regeneron	IL-4/IL-13 trap		Asthma		No development reported since 2006 (previously in phase I studies)
Synairgen	IL-4/IL-13 inhibitor	Peptide	Asthma and COPD		It 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.