Bococizumab
SPIRE trials: Bococizumab was insufficiently humanized for long-term use
The development of bococizumab, the third of the PCSK9 monoclonal antibodies, was discontinued by Pfizer in early November (1). Insights from a late breaker trial presentation provide some answers why this might be the case. SPIRE programme: lipid lowering trials The SPIRE program included 6…
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SPIRE-2: Cardiovascular benefit in very high risk patients
Evidence from the two cardiovascular outcomes studies with bococizumab, notably SPIRE-2, added to the buzz around FOURIER. According to PCSK9 Forum Editor Professor Philip Barter (University of New South Wales, Sydney, Australia): ‘Despite follow-up being short due to termination of the development of bococizumab, SPIRE-2…
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Bococizumab exits the PCSK9 stage: A response from PCSK9 Forum Editors
Pfizer announced on Tuesday, 1st November that it was discontinuing development of bococizumab, its PCSK9 inhibitor. According to the press release, the Company stated that: ‘The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering…
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SPIRE trials: Bococizumab met primary endpoint in 4 trials
Following on the tails of the first two licensed PCSK9 monoclonal antibodies, there are encouraging early results from Phase III trials with the third PCSK9 monoclonal antibody bococizumab. Topline results from studies in patients with heterozygous familial hypercholesterolemia (SPIRE-FH), high cardiovascular risk (SPIRE-HR), or elevated…
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SPIRE-2
Trial SPIRE-2: Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects ClinicalTrials.gov Identifier: NCT01975389 Aim To evaluate whether bococizumab compared to placebo reduces the occurrrence of major cardiovascular events in high risk subjects who are receiving background…
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SPIRE-1
Cardiovascular outcomes studies with bococizumab Trial SPIRE-1: Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects ClinicalTrials.gov Identifier: NCT01975376 Aim To evaluate whether bococizumab compared to placebo, reduces the occurrence of major cardiovascular events, including cardiovascular death, myocardial…
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SPIRE-LDL
Trial SPIRE-LDL: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events ClinicalTrials.gov Identifier: NCT01968967 Aim To assess the efficacy, safety and tolerability of bococizumab to lower LDL-C Study design Multicentre, double-blind, randomized, placebo-controlled, parallel-group study…
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SPIRE-LL
Trial SPIRE-LL: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events ClinicalTrials.gov Identifier: NCT02100514 Aim To assess the efficacy, safety and tolerability of bococizumab in subjects with hyperlipidemia on background statin therapy Study design…
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SPIRE-FH
Trial SPIRE-FH: A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia ClinicalTrials.gov Identifier: NCT01968980 Aim To assess the efficacy, safety and tolerability of bococizumab in subjects with heterozygous familial hypercholesterolemia Study design Multicentre double-blind, randomized, placebo-controlled,…
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SPIRE-HR
Trial SPIRE-HR: Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects with Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events ClinicalTrials.gov Identifier: NCT01968954 Aim To assess the efficacy, safety and tolerability of Pf-04950615 In subjects with primary hyperlipidemia or mixed dyslipidemia at risk of…
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SPIRE-AI
Trial SPIRE-AI: Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia ClinicalTrials.gov Identifier: NCT02458287 Aim To assess the efficacy, safety, tolerability and subcutaneous administration of bococizumab 150mg and 75mg with a pre-filled pen Study…
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SPIRE-SI
Trial SPIRE-SI: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins ClinicalTrials.gov Identifier: NCT02135029 Aim To demonstrate a superior lipid lowering effect of bococizumab compared to placebo in subjects who are statin intolerant Study design Multicentre, double-blinded, active- and placebo-controlled…
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ACC 2014 BMS-962476: First in man data
Trial BMS-962476: First in man data Aim To assess the effects of BMS-962476, a novel anti-PCSK9 agent Study design A randomised, double-blind, placebo-controlled, sequential panel, partial overlapping single ascending dose study Patient population Healthy subjects on diet with LDL-C levels >130 (3.4 mmol/L) and >190…
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Bococizumab: Phase II trial
Bococizumab: Phase II trial Reference: Ballantyne CM, Neutel J, Cropp A, et al. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, dose-ranging study in statin-treated subjects with hypercholesterolemia. Am J Cardiol 2015; 115:1212–21. Link: http://www.ncbi.nlm.nih.gov/pubmed/25784512 Trial Bococizumab:…
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