Recurrent pericarditis (RP) is a painful and debilitating autoinflammatory cardiovascular disease.
Inhibitor of interleukin-1α (IL-1α) and interleukin-1β (IL-1β), cytokines that have been shown to play a key role in inflammatory diseases.
Health plan claims analysis (cross-validated with published estimates) supports that there are approximately 40,000 patients with RP in the United States seeking and receiving medical treatment for RP.
Breakthrough therapy designation granted by the US Food and Drug Administration (FDA) for rilonacept for the treatment of RP.
Final data from an open-label Phase 2 clinical trial of rilonacept in a range of RP populations showed improvements in the study on clinically meaningful outcomes associated with the unmet need in RP: resolution of pericarditis episodes, reduction in recurrences of pericarditis episodes while on treatment, tapering and discontinuation of corticosteroids without pericarditis recurrence, and improved quality-of-life scores. Safety data from this study were consistent with the known safety profile of rilonacept.
RHAPSODY is a double-blind, placebo-controlled, randomized-withdrawal (RW) design study with open-label extension in subjects with symptomatic RP. After a run-in period with stabilization and tapering of background medications to monotherapy rilonacept, clinical responders will be randomized to continued rilonacept or placebo injected subcutaneously weekly during the 24-week RW period. The primary efficacy endpoint is time to first pericarditis recurrence in the RW period. Topline data are expected in the second half of 2020.
We are not aware of any current therapies approved by the FDA for the treatment of RP.