The discovery and clinical development of RPR 106541: an airway-selective steroid for the treatment of asthma

Abstract

RPR 106541 (Rhône-Poulenc Rorer), a potential inhaled anti-asthmatic steroid, was developed in an environment which recognised the central role of glucocorticoids in the treatment of airway inflammation, but perceived the need to improve upon the tolerance profile of existing drugs. Preclinical candidate selection was based upon a screening program in which potential NMEs were tested alongside known drugs in tests of efficacy and safety. The subsequent clinical program targeted early (Phase I) assessments of performance against plasma and urine markers of tolerance and a surrogate end point of efficacy. Data from each of the above phases are presented and the value of the overall strategy is assessed against clinical outcomes in Phase IIa.

• asthma
• drug development strategy
• glucocorticoid
• inflammation
• RPR10541
• surrogate markers