Roche Pharmaceutical Development and Sales Overview slide image

Roche Pharmaceutical Development and Sales Overview

Zinpentraxin alfa (PRM-151, RG6354) Recombinant human innate immunity protein pentraxin-2 Indication Idiopathic pulmonary fibrosis (IPF) Myelofibrosis Phase/study # of patients Design Primary endpoint Status Phase II N=117 Randomized, double-blind, placebo- controlled trial: 4-week screening period, 24-week randomized treatment period, 4- week follow-up visit (week 28) Zinpentraxin alfa at days 1, 3 and 5, then every 4 weeks vs placebo Least-squares mean change in FVC percentage of predicted value from baseline to week 28 Study met primary endpoint Data published in JAMA 2018;319(22):2299- 2307 and Lancet Respir Med 2019 Aug;7(8):657-664 Phase III STARSCAPE N=658 Randomized, double-blind, placebo- controlled trial: 4-week screening period, 52-week randomized treatment period Zinpentraxin alfa at days 1, 3 and 5, then every 4 weeks vs placebo Absolute change from baseline to week 52 in FVC FPI Q1 2021 Phase II N=125 Multiple dose study of zinpentraxin alfa Bone marrow response rate ■ Study completed Q1 2021 CT Identifier NCT02550873 FVC-Forced vital capacity, JAMA=Journal of the American Medical Association NCT04552899 NCT01981850 116 Roche Immunology
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