KIACTA™ - AA Amyloidosis

KIACTA™ is a novel oral treatment in Phase III clinical development for the treatment of AA Amyloidosis.

Clinical Trials

Details of the current KIACTA™ trial can be found at: Clinicaltrials.gov. NCT01215747. This is an International Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Efficacy and Safety of KIACTA™ in Preventing Renal Function Decline in Patients with AA Amyloidosis. This trial is expected to be completed in the first half of 2016.

Orphan Disease- AA Amyloidosis

This orphan disease is caused by the accumulation of amyloid deposits in internal organs, particularly the kidneys, and eventually may lead to end-stage renal failure/dialysis and death. These abnormal amyloid deposits are similar to, but distinct from, the amyloid plaques in the brain associated with Alzheimer’s disease. AA Amyloidosis occurs most commonly in patients with chronic inflammatory diseases, and in particular rheumatoid arthritis.

AA amyloidosis is a progressive and fatal condition that affects approximately 50,000 people in the United States, Europe and Japan with chronic inflammatory diseases, including rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, and Crohn's disease. The disease also occurs in patients suffering from other conditions ranging from chronic infections to inherited inflammatory diseases such as Familial Mediterranean Fever. No specific treatment is currently available for this orphan disease. Auven believes that based on the currently available incidence data for the underlying conditions of AA Amyloidosis, KIACTA™ will be addressing a large unmet medical need. KIACTA™ has received Orphan Drug Status in the United States and Orphan Medicinal Product designation in Europe.