A	B	C	D	E	F
1	Main
2		Brand Name	Arcalyst, fka IL-1 TRAP
3		Generic Name	rilonacept
4		Indication	Gout and CAPS (CIAS1-associated periodic syndrome, Cryopyrin-Associated Periodic Syndromes).
5			1000 patients WW
6		Mechanism	IL-1 receptor.
7			IL1 is a Protein secreted naturally by the body
8			acts as a messenger to help regulate immune and inflammitory responses by attaching to cell surface receptors in cells that participate in the immune system
9			In excess it is harmful and has been linked to a variety of inflammitory diseases
10			The Il 1 trap is designed to attach to and neutralize IL1 in the bloodstream before it can generate signals that can trigger disease activity
11			Once attached to the trap, IL1 cannot bind to the cell surface and is flushed from the body together with the trap
12		Clinical Trials
13			6/10/2005 - Phase II results
14			preliminary results from once weekly dosing of interleukin-1 trap in patients with cias1 associated periodic syndrome (caps)
15				(a family of autoinflammitory diseases)
16			all 4 patients enrolled to date experienced a positive response to a subcutaneous loading dose regimen
17				this includes a sizable reduction in daily patient diary scores and acute phase reactant levels
18			the study was conducted with the National Institute of Arthriits and Musculoskeletal and Skin Diseases
19				The senior investigators in this study are Raphaela Goldbach-Mansky, M.D., Staff Clinician with NIAMS, and Daniel Kastner, M.D., Ph.D., Chief, Genetics and Genomics Branch with NIAMS
20
21			Phase 3 gout study (n = 248)
22			16 week study, Arcalyst dosed SC.
23				PBO	80 mg Arcalyst	160 mg Artcalyst
24			# gout flares	1.23	0.35	0.34
25
26			Drug appears to reduce gout flares, which occur even with urate inhibitors.
27			Would be used when patients start on urate inhibitors, but just be used short term. REGN estimates ~750K/year in US.
28			sBLA expected to be filed in 2011.