- Preliminary data from an open-label Phase 2 pilot study evaluating Kiniksa Pharmaceuticals' (NASDAQ:KNSA) lead candidate rilonacept in patients with symptomatic recurrent pericarditis (inflammation of the saclike membrane surrounding the heart) showed a positive effect.
- 12 patients, each with at least three episodes of pericarditis, were enrolled in a six-week base treatment period. Each received a loading dose of 320 mg of rilonacept followed by weekly maintenance of 160 mg on top of NSAIDs and/or colchicine and/or corticosteroids.
- Average pericardial pain dropped 76% from baseline as measured by an 11-point scale (NRS) at week 6.
- Mean C-reactive protein, a heart inflammation biomarker, dropped 92% from baseline with a median time to normalization of nine days.
- Pericardial signs resolved.
- On the safety front, rilonacept was generally well-tolerated. There was one serious treatment-related adverse event, a skin abscess, which resulted in discontinuation but responded to treatment.
- A Phase 3 trial, RHAPSODY, is underway.
- Rilonacept is a subcutaneously administered recombinant fusion protein that blocks Interleukin-1α and Interleukin-1β signaling. It is marketed under the brand name Arcalyst by Regeneron Pharmaceuticals (NASDAQ:REGN). Kiniksa in-licensed exclusive rights for recurrent pericarditis and certain other indications.
- Management will host a conference call this morning at 9:00 am ET to discuss the results.
- Now read: Omeros collaborates University of Cambridge
Original article