Immune-modulating, clinical-stage product candidates targeting underserved conditions and offering the potential for differentiation.

Pipeline

Program & Target
Preclinical
Phase 1
Phase 2
Phase 3
Commercial
Kiniksa rights

PROGRAM & TARGET

Cardiovascular Franchise

ARCALYST®
(rilonacept)1,2

IL-1α & IL-1β

PHASE: COMMERCIAL

Recurrent Pericarditis
Worldwide4
(Excluding MENA)
Kiniksa Rights
Worldwide4
(Excluding MENA)

PROGRAM & TARGET

Cardiovascular Franchise

Mavrilimumab3

GM-CSFRα

PHASE: 1

Evaluating development in rare cardiovascular diseases
Worldwide4
Kiniksa Rights
Worldwide4

PROGRAM & TARGET

Autoimmune Franchise

KPL-404

CD40/CD154

PHASE: 2

Rheumatoid Arthritis
Worldwide
Kiniksa Rights
Worldwide
Vixarelimab
OSMRβ
Roche and Genentech
GLOBAL rights FOR ALL INDICATIONS5

1 Approved in the U.S; ARCALYST is also approved for cryopyrin-associated periodic syndromes (CAPS) and deficiency of the interleukin-1 receptor antagonist (DIRA);

2 The FDA granted Breakthrough Therapy designation to ARCALYST for recurrent pericarditis in 2019; the FDA granted Orphan Drug exclusivity to ARCALYST in March 2021 for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older. The European Commission granted Orphan Drug designation to ARCALYST for the treatment of idiopathic pericarditis in 2020;

3 Phase 2 clinical trials of mavrilimumab in rheumatoid arthritis and giant cell arteritis achieved their primary and secondary endpoints with statistical significance;

4 Kiniksa granted Huadong Medicine exclusive rights in the Asia Pacific Region, excluding Japan;

5 In September 2022, Kiniksa granted Genentech and Roche exclusive global rights to develop and commercialize vixarelimab; 

IL-1α = interleukin-1α ; IL-1β = interleukin-1β; GM-CSFRα = granulocyte macrophage colony stimulating factor receptor alpha; OSMRβ = oncostatin M receptor beta; MENA = Middle East and North Africa.

 

Patient Support & Treatment Access