BioInvent: Announcement of topline results from the GLACIER study


BioInvent International AB (BINV.ST)(BINV.ST) 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."

BioInvent will host a teleconference today at 11 am CET addressing the outcome of the study. Participants are invited to dial in at: 08 505 20424 (Sweden) or +44 (0)203 003 2666 (International), password BioInvent.