Quantum Leap Healthcare Collaborative (QLHC), the sponsor of the I-SPY COVID Trial, announced that apremilast (Otezla), made by Amgen, has been dropped for futility. Apremilast was chosen for testing in the I-SPY COVID Trial because it is a phosphodiesterase-4 (PDE4) inhibitor hypothesized to blunt the cytokine storm that accompanies critical illness associated with COVID-19.

The I-SPY COVID Trial is a phase II, open label, adaptive platform trial being conducted in critically ill COVID-19 patients who are receiving high flow oxygen or mechanical ventilation. The trial was designed to rapidly screen agents to find those with the best chance of reducing time to recovery (defined as reduction in oxygen demand) by approximately 50% and reducing risk of death.

The I-SPY COVID Trial identified the initial agents for the study through a unique partnership with the COVID R&D Alliance, and apremilast was the first agent identified and approved to go forward through this mechanism.

QLHC discontinued testing of apremilast (Otezla) in the I-SPY COVID Trial because, after 67 patients enrolled, the agent met the predefined futility criterion, defined as at least 90% probability that the hazard ratio for time to recovery is less than 1.5 compared to the control arm.

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