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| Phase I/II trial in moderate, persistent allergic asthmatics (NCT00598104) was withdrawn due to the lack of enrolment and complexity of design | |||||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.