Simtuzumab, also known as GS-6624, is a pipeline drug under development by Gilead Sciences for the treatment of idiopathic pulmonary fibrosis and related conditions including cirrhosis from non-alcoholic steatohepatitis (NASH).
History of Simtuzumab
Following preclinical studies in animal models and safety tests in humans, Gilead is conducting Phase 2 clinical trials to test the safety, efficacy, histologic progression and tolerability of the drug in patients with IPF or advanced pulmonary fibrosis.
How Simtuzumab Works
Simtuzumab is a humanized monoclonal antibody with immunomodulatory qualities. It binds to the scavenger receptor cysteine rich domain 4 (SRCR4) on the lysil oxidase-like 2 (LOXL2) enzyme and blocks its ability to recruit fibroblasts and allow cross-linking of collagen. This leads to inhibiting synthesis of growth factors and stopping chemokines, cell growth, differentiation and proliferation. LOXL2 is essential in synthesis of connective tissues. It helps cross-linking of collagen and elastin. As a result, inhibition of LOXL2 is crucial for preventing excess formation of connective tissue and consequent fibrosis.
Next Steps For Simtuzumab
A Phase 2b, dose-ranging, randomized, double-blind, placebo-controlled trial is currently underway, with 222 patients who range in age from 18 to 65. The study, initiated in December 2012, is scheduled to continue through December 2023.
Enrollment for another Phase 2, randomized, double-blind, placebo-controlled, multi-center study wazs opened for enrollment in February 2013. The study aims to enroll 500 patients aged 45 -85 and will likely be completed by January 2018.
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