Summary of Clinical Use

Phase 1 clinical trial NCT01777243 was completed in patients with systemic amyloidosis to assess treatment with GSK2398852 in combination with miridesap (GSK2315698, a SAP depleting chemical [1]). Development in amyloidosis was discontinued, and phase 2 study NCT03044353 was terminated.

Mechanism Of Action and Pharmacodynamic Effects

Amyloidosis is a rare disease that results from accumulation of misfolded proteins, or amyloids. SAP stabilises amyloid fibrils and protects them from proteolytic breakdown [5]. and plays a role in the pathogenesis of systemic amyloidosis [2]. Antibodies against SAP are reported to effectively clear visceral amyloid deposits in mice by inducing a potent, complement dependent, macrophage-derived giant cell reaction [1].

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT01777243	A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis	Phase 1 Interventional	GlaxoSmithKline		3-4
NCT03044353	Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698	Phase 2 Interventional	GlaxoSmithKline