GS-5745 for CF Lung Inflammation in Cystic Fibrosis

GS-5745 is a monoclonal antibody that may help reduce inflammation in the lungs, leading to improved lung function in people with cystic fibrosis (CF).1

How GS-5745 works

GS-5745 inhibits matrix metalloproteinase 9 (MMP-9) — an extracellular enzyme involved in matrix remodeling, tumor growth, and metastasis — and has antineoplastic potential. Once administered, GS-5745 binds to MMP-9 and inhibits its enzymatic activity. This prevents extracellular matrix protein degradation and, potentially, blocks tumor growth, invasion, and metastasis. MMP-9 plays an important role in the degradation of collagens and proteoglycans, and increased MMP-9 activity has been linked to increased invasion and cancer metastasis.2

GS-5745 studies

Preclinical studies showed that blocking MMP-9 alters the tumor microenvironment, and it is associated with greater chemotherapy penetration and improved anti-tumor immunity.3

A Phase 2 study to evaluate the effect of GS-5745 on FEV1 (forced expiration in one second, a measure of lung health) in adults with cystic fibrosis (NCT02759562) is recruiting participants. The study will evaluate GS-5745’s effect on pre-bronchodilator FEV1 in adults with CF after eight weeks of treatment. There will be two parts to the study: In the first, GS-5745 at 600 mg or placebo will be administered for eight weeks. In the second, GS-5745 at 300 mg, 150 mg, or placebo will be administered for eight weeks. Part 2 will be initiated once Part 1 is completed.

Its primary goal is absolute change in pre-bronchodilator FEV1 percent predicted, as measured from baseline to week eight.

The study is expected to be completed in March 2019.

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