Article Text
Abstract
Objective A large body of literature suggests that prevention of fibrosis – which contributes to chronicity of lupus nephritis (LN) - may significantly improve long-term prognosis. Bone morphogenetic protein-7 (BMP-7) was first identified as a therapeutic option in this context decades ago and evidence of its benefit in the context of fibrosis in various conditions, including LN, is ever-increasing. Despite these facts, BMP-7 is not being implemented as therapy in the context of renal disease. Our objective was to understand the hurdles to implementation of this promising therapeutic modality.
Methods A comprehensive review of the peer-reviewed (rheumatic and non-rheumatic) literature on BMP-7 was conducted to identify potential physiological risks which may preclude implementation of BMP-7 as treatment in the context of LN. In addition, information on commercial BMP-7 drug development initiatives was collated, to assess potential economic reasons for lack of BMP-7-based pharmaceuticals. Finally, we conducted a general search of literature to find potential solutions to the high cost of clinical trials in general, to enable recommendations on ways in which to increase feasibility of BMP-7 clinical trials.
Results From a large body of literature consulted, no significant risk of adverse outcome could be identified for BMP-7. In the context of pharmaceutical manufacturing itself, high production cost was identified as a potential limiting factor. The choice of primary disease focus in initial clinical trials seem to be another significant indicator of early failure of a potential drug, as well as the generally high cost of clinical trials.
Conclusion We concluded that modern technology should be integrated into modern medicine as a priority to increase drug development success rate and propose a bench-to-bedside pipeline by which this may be achieved.
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