A currently recruiting Phase 2 clinical trial from Sanofi, “Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (ESTAIR),” will be investigating how a novel antibody treatment may help patients with idiopathic pulmonary fibrosis (IPF). The novel therapeutic, SAR156597, will be tested against a placebo to determine if it is efficacious in improving lung function in patients with IPF.
SAR156597 was granted Orphan Drug Designation by the FDA in September 2011. It is a bi-specific monoclonal antibody, meaning that it binds specifically to two targets: interleukin 4 (IL4) and interleukin 13 (IL13). “Therapeutic Targeting of IL-4- and IL-13-responsive Cells in Pulmonary Fibrosis,” a research study investigating different types of pulmonary fibrosis that was published in Immunologic Research, concluded that IL4 and IL13 are necessary for pulmonary fibrosis to start and progress. This study highlighted the importance of therapeutics such as SAR156597 that are targeted against IL4 and IL13.
A Phase 1/2 clinical trial has already been completed for SAR156597: “To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF).” The goal of the study was to assess the safety and tolerability of subcutaneously delivered weekly doses of SAR156597 over a period of six weeks. Patient pulmonary function and drug distribution throughout the body were also assessed.
After investigating the safety of different doses, Sanofi has decided on two dosing schemes to use in the current Phase 2 trial that will last for one year of patient dosing, followed by a 12-week follow-up period. Patients will be treated either once every week or once every two weeks with a subcuatneous formulation of SAR156597. This time, the primary focus of the study is to establish the efficacy of SAR156597 in improving IPF patient lung function. The secondary foci are to establish efficacy in slowing disease progression and to further explore the safety profile of patients treated with weekly injections of SAR156597.
An estimated 300 patients will enroll in the study, which began in May 2015. Sanofi estimates the trial will be completed in July of 2017, at which time they will conduct the final data collection for primary efficacy outcomes. Thereafter, data analysis will indicate if SAR156597 is a promising treatment for patients with IPF.