Kiniksa sees 2024 ARCALYST net product revenue $360M-$380M

Portfolio Execution: ARCALYST: ARCALYST net product revenue was $71.2 million and $233.1 million for the fourth quarter and full year 2023, respectively. Since launch in April 2021, more than 1,700 prescribers have written ARCALYST prescriptions for recurrent pericarditis. As of the end of the fourth quarter of 2023, average total duration of ARCALYST therapy in recurrent pericarditis increased to approximately 23 months. As of the end of the fourth quarter of 2023, approximately 9% of the target 14,000 multiple-recurrence patients were actively on ARCALYST treatment. Kiniksa increased the size of its salesforce to approximately 85 representatives by the end of 2023 to help drive further physician adoption and patient enrollments in 2024. Kiniksa expects 2024 ARCALYST net product revenue of between $360 million and $380 million. Abiprubart: Kiniksa announced that the Phase 2 clinical trial of abiprubart in rheumatoid arthritis met its primary efficacy endpoint, change from baseline in Disease Activity Score of 28 Joints Using C-reactive Protein versus placebo. In Cohorts 1 and 2 multiple doses of abiprubart were well-tolerated and enabled the proof-of-concept portion of the study. Although these cohorts were not powered for DAS28-CRP, the following results were observed: In Cohort 1, in the abiprubart 2 mg/kg subcutaneous biweekly dosing group the mean change from baseline in DAS28-CRP at Week 12 was -3.16 points compared to -1.09 points in pooled placebo recipients. In Cohort 2, in the abiprubart 5 mg/kg SC biweekly dosing group, the mean change from baseline in DAS28-CRP at Week 12 was -3.44 points compared to pooled placebo recipients. In Cohort 3, in the abiprubart 5 mg/kg SC weekly dosing group, the Least Squares mean change from baseline in DAS28-CRP at Week 12 was -2.21 points compared to -1.65 points in placebo recipients. In Cohort 3, in the abiprubart 5 mg/kg SC biweekly dosing group, the LS mean change from baseline in DAS28-CRP at Week 12 was -2.00 points compared to -1.65 points in placebo recipients. Abiprubart significantly reduced Rheumatoid Factor by over 40% in both Cohort 3 dose levels. Abiprubart was well-tolerated, with no dose-related adverse experiences observed. Kiniksa has now completed enrollment in a fourth cohort of the Phase 2 clinical trial of abiprubart in rheumatoid arthritis. Cohort 4 will evaluate a fixed dose level administered as a single subcutaneous injection once monthly. The company expects data from Cohort 4 in the second quarter of 2024. Mavrilimumab: Kiniksa is now evaluating potential partnership opportunities to advance development of mavrilimumab, which has generated positive data in mid-stage clinical trials across multiple indications.