BioInvent International AB (OMXS:BINV) today announced data from the
GLACIER phase IIa study evaluating BI-204 in patients with stable
atherosclerotic vascular disease. BioInvent is developing BI-204 in
collaboration with Genentech, a member of the Roche Group (SIX: RO, ROG;
OTCQX: RHHBY).
In the study, BI-204 was administered either as a single dose or in
multiple doses over a twelve week period in addition to
standard-of-care. The primary endpoint of the study was the relative
change in inflammatory activity in an index arterial vessel after twelve
weeks, as measured by FDG-PET/CT imaging ([18F]-2-deoxyglucose
positron emission-tomography/computed tomography). No statistically
significant reduction between placebo and the two active treatment arms
was observed. Thus, the study did not meet its primary endpoint.
Based on preliminary safety data review, BI-204 was well-tolerated and
no drug-related safety signals were identified. An analysis of
additional safety and efficacy data will be available at a later date.
Svein Mathisen, CEO of BioInvent, comments: "We conclude that BI-204 did
not meet the primary objective set out in the GLACIER study. Before
deciding on the future of BI-204, we and our partner Genentech need to
finalize the full data analysis. We expect to provide an update later
this year."
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