Rilonacept is a recombinant fusion protein injected weekly under the skin.
The trial “met its prespecified primary and all major secondary efficacy endpoints, showing that rilonacept improved clinically meaningful outcomes,” the Hamilton, Bermuda, company said.
The Food and Drug Administration in 2019 granted Breakthrough Therapy designation to rilonacept to treat pericarditis, and Kiniksa later this year expects to submit a Supplemental Biologics License Application, it said.
“[Our] pivotal Phase III trial of rilonacept in recurrent pericarditis met its primary and all major secondary efficacy endpoints,” Chief Executive Sanj Patel said in a statement.
“Combined with a well-tolerated safety profile and a weekly dosing regimen, these data are an important step forward for patients. ... [Rilonacept] has the potential to be the first FDA-approved therapy for recurrent pericarditis.”
The trial tested 61 actively symptomatic recurrent pericarditis patients who were failing standard-of care-treatment. Rilonacept recipients saw a 96% reduction in risk of recurrent pericarditis events, Kiniksa said.
“Upon receipt of FDA approval for rilonacept in recurrent pericarditis, Kiniksa would assume the sales and distribution of rilonacept for the approved indications in the U.S. and will evenly split profits on sales with Regeneron,” Kiniksa said.
Kiniksa shares recently traded at $27.09, up 18%. They have more than doubled in the past three months.
Regeneron traded at $612.49, up 0.20%. It has climbed 37% in the past three months.