Biogen: Phase 2/3 Study in X-Linked Retinitis Pigmentosa Didn't Meet Primary Objective
By Michael Dabaie
Biogen Inc. said the Phase 2/3 Xirius study of cotoretigene
toliparvovec as a one-time therapy for patients with X-linked
retinitis pigmentosa didn't meet its primary objective.
The company said that data indicated positive trends in several
prespecified secondary endpoints, such as a clinically relevant
measure of visual acuity.
XLRP is a rare, inherited retinal disease that is associated
with progressive vision loss as the light-sensing cells of the
retina gradually deteriorate.
The study didn't meet its primary endpoint of demonstrating a
statistically significant improvement in the proportion of treated
study eyes with >=7 dB improvement from baseline at >=5 of
the 16 central loci of the 10-2 grid assessed by macular integrity
assessment microperimetry, the company said.
"Although the Phase 2/3 Xirius study of cotoretigene
toliparvovec did not meet its primary endpoint, we are encouraged
by positive trends in other pre-specified clinically relevant
endpoints, such as a measure of visual acuity under low light
conditions," said Katherine Dawson, head of the therapeutics
development unit at Biogen.
Biogen said it will communicate next steps for the program after
analyzing the complete data set.
Write to Michael Dabaie at email@example.com
(END) Dow Jones Newswires
May 14, 2021 08:14 ET (12:14 GMT)
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