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news.Clinical Data’s Stedivaze (apadenoson), an agonist of the adenosine A2A receptor subtype in development as a pharmacologic stress agent for myocardial perfusion imaging (MPI), has demonstrated overall safety and tolerability in patients with asthma and chronic obstructive pulmonary disease (COPD) in a Phase I study.
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In the Phase 1 trial Stedivaze was administered to patients with mild to moderate asthma as a single IV bolus, the same as utilized in the ongoing Phase III ASPECT 1 trial.
Results from the trial showed that treatment with Stedivaze did not have any effects on pulmonary function and did not induce bronchoconstriction.
Additionally, results of the trial support the tolerability of Stedivaze and continued study in patients with mild or moderate asthma.
In another Phase I, placebo-controlled study, Stedivaze was administered to patients with moderate to severe COPD as a single IV bolus, the same as utilized in the ongoing Phase III ASPECT 1 trial.
Results from the trial showed that treatment with Stedivaze did not have any effects on pulmonary function and there appeared to be no association between severity of disease and the overall incidence or severity of treatment emergent adverse events.
Clinical Data executive vice president and chief medical officer Carol Reed said that they are planning an expanded safety study of Stedivaze in patients with asthma and COPD, while continuing to evaluate the efficacy and potential for superior tolerability of Stedivaze in our ongoing Phase III ASPECT 1 trial.