Clinical Studies

Timapiprant

Completed Studies

Phase 2a study in atopic dermatitis

This study demonstrated no significant differences between timapiprant and placebo in the primary or secondary endpoints. timapiprant was well tolerated with a similar safety profile compared to previous studies.

Phase 2a study in allergic asthmatics

This one month POC study showed that timapiprant led to improvement in FEV1 as primary endpoint.

This study was in steroid naïve subjects with moderate persistent asthma. timapiprant was administered in capsules (without formulation). The study demonstrated an improvement in lung function and symptoms and a reduction in sputum eosinophilia and respiratory infections (Barnes et al., 2012).

Phase 2a study in allergic rhinitis and conjunctivitis

This POC Vienna Challenge Chamber study demonstrated reduction in both nasal and eye symptoms in allergic subjects exposed to grass pollen out of season (Horak et al., 2012).

Phase 2b study in mild-to-moderate asthma

This three month dose ranging study was in steroid naïve mild-to-moderate persistent asthmatics. It demonstrated that timapiprant is effective when administered as a low dose (25 mg) once a day in subjects with the eosinophilic Th2 high phenotype. Subjects showed improvements in both lung function, as measured by the primary endpoint of FEV1, and quality of life resulting from an improvement in other symptoms (Pettipher et al., 2014).

Timapiprant phase2a study in eosinophilic asthma

Current Studies

Phase 2 POC study for severe, steroid-resistant, eosinophilic asthmatics

The Phase 2 trial is designed to evaluate the effect of timapiprant on induced sputum eosinophil count. Subjects will be treated with either placebo or timapiprant once daily for a period of 12 weeks, at which point their induced sputum eosinophil count will be measured and compared to baseline. The study is expected to enrol up to 40 patients and will be conducted in the United Kingdon. Professor Ian Pavord, Univerity of Oxford, is the principal investigator.

Phase 2a study on response of asthmatics to rhinovirus infection (common cold)

This study is sponsored by Imperial College and is grant funded through the Biomedical Catalyst programme, and led by Professor Sebastian Johnston and Dr David Jackson, Imperial College. The primary endpoint is the Lower Respiratory Symptom Score.

Phase 3 study (Russia) in mild to moderate eosinophilic asthmatics

This is a Russian Registration study of lung function in mild/moderate eosinophilic asthmatics which is sponsored by Eleventa LLC. The study looks at the effect of timapiprant vs placebo measured by FEV1 at 12 weeks.

ATX2417

Current Studies

Phase 1 SAD/MAD study

This is a Phase 1 study in volunteers evaluating single ascending doses and multiple ascending doses of ATX2417, together with an assessment of the effects of food.