In July 2023, Enzyvant, now Sumitomo Pharma America, a subsidiary of Sumitomo Pharma, announced an update on their Phase 2 ELEVATE 2 study of Rodatristat Ethyl for PAH. The Phase 2b study failed to lower pulmonary vascular resistance, as measured by right heart catheterization, at Week 24.
Sumitomo undertook a very rigorous evaluation of Rodatristat Ethyl in PAH. This included evaluating the molecule in animal models, as well as in both single and multi-dose studies in healthy people. The structure of their Phase 2 study was excellent, incorporating the best learnings from the past 20 years of clinical trials in the space.
The Rodatristat Ethyl story reminds us that there is still much we don’t understand about PAH, the mechanisms that lead to the disease and the potential medications that might be of benefit. Developing innovative, safe and effective medicines is a hard undertaking and success is not guaranteed. Yet even still, based on the results of this study, we have advanced our understanding of the biology of PAH and the potential role of serotonin in PAH.
There is no guarantee in life and there is no guarantee in drug development. Only through perseverance and a continued commitment to innovation will we make further progress in PAH.