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
ImmunologyView entire presentation