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).
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).
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).
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.
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.