Date: 2012-07-11
Type of information:
phase: 2a
Announcement: results
Company: Bioinvent International (Sweden) Genentech a member of the Roche Group (USA-Switzerland)
Product: BI-204
Action
mechanism: BI-204 is a human antibody derived from BioInvent’s proprietary antibody library n-CoDeR®.The antibody targets oxidised forms of a lipoprotein (apoB100), which is a component of the LDL particle( “bad cholesterol”). Research in recent years has shown strong links between these oxidised particles and harmful inflammatory processes in the vessel walls. Such inflammation results in the formation of atherosclerotic plaque that may fragment and cause blood clots. Results support that the mechanism behind BI-204 is a modulation of the inflammatory process, resulting in a reduction of pro-inflammatory cells in treated plaques, which in turn leads to a reduction in new plaque formation and the regression of existing plaques. BI-204 is being developed for secondary prevention of cardiovascular events, such as myocardial infarctions, in patients with acute coronary syndromes.
Disease: atherosclerosis and acute coronary syndromes
Therapeutic area: Cardiovascular diseases
Country: USA, Canada
Trial
details: GLACIER (Goal of oxidised Ldl and ACtivated macrophage Inhibition by Exposure to a Recombinant antibody) enrolled 147 patients, exploring the anti-inflammatory effect of BI-204, administered either as a single dose or in multiple doses, compared to placebo on top of standard of care, including statins, in patients with stable atherosclerotic cardiovascular disease. Vascular inflammation was quantified by FDG-PET/CT imaging, with the primary endpoint defined as the target-to-background ratio in the most diseased segment (MDS-TBR), a ratio between the FDG uptake signal in the vessel wall and the background blood pool.
Latest
news: * On July 11, 2012, BioInvent International has announced data from the GLACIER phase IIa study evaluating BI-204 in patients with stable atherosclerotic vascular disease. 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. Before deciding on the future of BI-204, Bioinvent International and Genentech will finalize the full data analysis. The partners expect to provide an update later this year.
* On June 29,2012, BioInvent has announced that the company has decided to initiate negotiations with trade unions regarding organisational changes. The decision is due to the fact that development of the antithrombotic agent TB 402 has been stopped. The company’s resources will therefore be reprioritised to focus on the continued development of BI 204 for the treatment of acute coronary artery disease and new and existing cancer projects such as BI 505. The new organisation is planned to have 68 full-time employees compared with the current 89. The reduction in work force and other reprioritisations are expected to result in cost savings of around SEK 15 million on a full-year basis, fully effective from January 2013.
* On March 2, 2012, BioInvent International and Genentech have announced that all patients have completed enrollment in the GLACIER study, a phase IIa study with BI-204 in patients with stable atherosclerotic vascular disease. BioInvent expects to publicly release top-line data from the study in Q3 2012. The product candidate BI-204 (anti-oxLDL, MLDL1278A, RG7418) is being developed in collaboration with Genentech. Genentech holds the rights to North America while BioInvent retains the rights to all other territories.
* On March 14, 2011, BioInvent has announced that the first patient has been dosed in this Phase II study. This is a multicenter, randomized, double-blind, placebo-controlled study of BI-204, delivered intravenously to patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease. The trial will enrol 120 patients at approximately 20 centres in the United States and Canada. It is designed to demonstrate a reduction in plaque inflammation following treatment as quantified by FDG-PET imaging (18F 2 deoxyglucose positron emission tomography). Trial start triggers $ 15 million milestone from Genentech.
