More woes for Teva as two late-stage asthma studies bomb
pharmafile | January 23, 2018 | News story | Manufacturing and Production, Research and Development | Teva, asthma, pharma
In yet more bad news for Teva, it has emerged that two of the firm’s late-stage studies in asthma have bombed, failing to meet their primary endpoints.
Both trials involved the Israeli company’s drug reslizumab. The first, investigating the efficacy of the treatment when administered subcutaneously in patients with uncontrolled asthma and blood eosinophil levels of more than 300/mcL, found that reslizumab failed to adequately reduce the frequency of clinical asthma exacerbations (CAEs). In the second study, investigating the drug’s efficacy in patients with oral corticosteroid (OCS)-dependent asthma, reslizumab could not bring down daily OCS doses, failing its primary endpoint.
However, Teva has attempted to spin the news, arguing that, despite the failure of the trials, an analysis of a subgroup of the patient population used in the first study found that 80% of those with baseline blood eosinophil counts of at least 400/mcL responded well to treatment, showing a significant reduction in CAE risk.
“These results reinforce the role of eosinophils in severe asthma disease biology and the importance of defining the right blood eosinophil cut-off point for patient selection,” commented Tushar Shah, Senior Vice President of Specialty Clinical Development and Medical Affairs at Teva. “We continue to see the positive impact of the intravenous formulation as a clinically effective…weight-based dosing option in patients with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care therapy.”
Matt Fellows
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