A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Bococizumab (Pf-04950615) In Asian Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab 150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for CV events. The study will enroll a total of approximately 750 subjects from 4 - 5 Asian countries/areas (including China mainland); of which approximately 600 subjects will be from sites in China. Subjects will be randomized into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.

Start Date31 Oct 2016

Sponsor / Collaborator

Pfizer Inc.

NCT02524106

/ TerminatedPhase 3IIT

Bococizumab HIV Evaluation (B-HIVE) Study: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Bococizumab, a PCSK9 Inhibitor, in HIV-Infected Subjects

B-HIVE is a Phase 3, double blind, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of bococizumab 150 mg subcutaneously every 2 weeks to bococizumab placebo subcutaneously every 2 weeks for LDL-C lowering in HIV-infected subjects.

Start Date01 Aug 2016

Sponsor / Collaborator

The University of California, San Francisco

[+2]

CTR20160159

/ SuspendedPhase 3

评估Bococizumab减少高危受试者主要心血管事件发生风险的疗效、安全性和耐受性的III期研究

[Translation] A Phase III study to evaluate the efficacy, safety, and tolerability of Bococizumab in reducing the risk of major cardiovascular events in high-risk subjects

本临床试验的主要目的是在接受背景降脂治疗但LDL-C≥70 mg/dL（1.81 mmol/L）或非HDL-C≥100 mg/dL（2.59 mmol/L）的主要心血管事件高危或极高危受试者中证明Bococizumab在降低主要心血管事件风险方面的疗效优于安慰剂。主要心血管事件是一个包括经裁定并证实的心血管死亡、非致死性心肌梗死、非致死性卒中及因需要紧急血运重建的不稳定型心绞痛住院的复合终点。

[Translation]

The primary objective of this clinical trial was to demonstrate that bococizumab is superior to placebo in reducing the risk of major cardiovascular events (a composite endpoint of adjudicated and confirmed cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina requiring urgent revascularization) in subjects at high or very high risk for major cardiovascular events who had LDL-C ≥70 mg/dL (1.81 mmol/L) or non-HDL-C ≥100 mg/dL (2.59 mmol/L) while receiving background lipid-lowering therapy.

Start Date09 Jul 2016

Sponsor / Collaborator

Pfizer Inc.

[+2]

100 Clinical Results associated with Bococizumab

100 Translational Medicine associated with Bococizumab

100 Patents (Medical) associated with Bococizumab

Literatures (Medical) associated with Bococizumab

01 Nov 2024·Health Science Reports

PCSK9 Inhibitors: The Evolving Future

Article

Author: Kapoor, Kapil ; Jeswani, Bijay Mukesh ; Bhatheja, Rohit ; Nazir, Abubakar ; Rathore, Sawai Singh ; Sharma, Shubhangi

ABSTRACT:

Introduction:

PCSK9 inhibitors are a novel class of medications that lower LDL cholesterol (LDL‐C) by increasing LDL receptor activity, promoting clearance of LDL‐C from the bloodstream. Over the years, PCSK9 inhibitors have been explored as adjunct therapies to statins or as monotherapy in high‐risk cardiovascular patients.

Aim:

This review aims to provide an updated perspective on PCSK9 inhibitors, assessing their clinical efficacy, safety, and significance, especially in light of recent clinical trials.

Methods:

The review examines the role of PCSK9 in cholesterol regulation and summarizes the results of major cardiovascular trials, including FOURIER, SPIRE‐1, SPIRE‐2, and ODYSSEY Outcomes. It also discusses emerging treatments like small interfering RNA (siRNA) therapies and evaluates PCSK9 inhibitor effects on LDL‐C and lipoprotein(a) levels.

Results:

Clinical trials have shown PCSK9 inhibitors reduce LDL‐C by up to 60%. In the FOURIER trial, evolocumab reduced LDL‐C by 59% and major cardiovascular events by 15%–20%. The SPIRE‐2 trial, despite early termination, showed a 21% risk reduction in the primary composite endpoint with bococizumab. The ODYSSEY Outcomes trial reported a 57% LDL‐C reduction with alirocumab, alongside a 15% reduction in adverse events. Emerging treatments like Inclisiran offer long‐term LDL‐C control with fewer doses. PCSK9 inhibitors are generally well‐tolerated, with the most common side effect being injection site reactions.

Conclusion:

PCSK9 inhibitors significantly lower LDL‐C and reduce cardiovascular events, offering promising therapies for high‐risk patients, including those with familial hypercholesterolemia (FH) and those who cannot tolerate statins. Future research will focus on optimizing these inhibitors, integrating complementary therapies, and exploring gene‐editing technologies to improve patient outcomes.

31 Dec 2023·mAbs

Rapid in vitro assessment of the immunogenicity potential of engineered antibody therapeutics through detection of CD4 ⁺ T cell interleukin-2 secretion

Article

Author: Mishima, Masayuki ; Ikuno, Tatsuya ; Mizuno, Hideaki ; Takeiri, Akira ; Yano, Mariko ; Arata, Yoshiyuki ; Motoyama, Shigeki ; Nishito, Yukari ; Yabuki, Nami ; Tabo, Mitsuyasu ; Matsushita, Tomochika ; Kiyokawa, Jumpei ; Suzuki, Hiromi ; Ito, Shunsuke ; Chiba, Shuichi ; Kubo, Chiyomi ; Honda, Masaki ; Sampei, Zenjiro

Therapeutic antibodies sometimes elicit anti-drug antibodies (ADAs) that can affect efficacy and safety. Engineered antibodies that contain artificial amino acid sequences are potentially highly immunogenic, but this is currently difficult to predict. Therefore, it is important to efficiently assess immunogenicity during the development of complex antibody-based formats. Here, we present an in vitro peripheral blood mononuclear cell-based assay that can be used to assess immunogenicity potential within 3 days. This method involves examining the frequency and function of interleukin (IL)-2-secreting CD4⁺ T cells induced by therapeutic antibodies. IL-2-secreting CD4⁺ T cells seem to be functionally relevant to the immunogenic potential due to their proliferative activity and the expression of several cytokines. The rates of the donors responding to low and high immunogenic proteins, mAb1, and keyhole limpet hemocyanin were 1.3% and 93.5%, respectively. Seven antibodies with known rates of immunogenicity (etanercept, emicizumab, abciximab, romosozumab, blosozumab, humanized anti-human A33 antibody, and bococizumab) induced responses in 1.9%, 3.8%, 6.4%, 10.0%, 29.2%, 43.8%, and 89.5% of donors, respectively. These data are comparable with ADA incidences in clinical settings. Our results show that this assay can contribute to the swift assessment and mechanistic understanding of the immunogenicity of therapeutic antibodies.

01 Dec 2023·CPT: pharmacometrics & systems pharmacology

Population PK/PD modeling of low‐density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti‐PCSK9 monoclonal antibody

Article

Author: Yunis, Carla ; Sweeney, Kevin ; Gibiansky, Leonid ; Wang, Ellen Q ; Plowchalk, David ; Kaila, Nitin

Abstract:

We sought to characterize the population pharmacokinetic/pharmacodynamic (PK/PD) relationship of bococizumab (RN316/PF‐04950615), a humanized IgG2Δa monoclonal antibody that binds to secreted human proprotein convertase subtilisin kexin type 9 (PCSK9), using data derived from 16 phase I, II, and III clinical studies (36,066 bococizumab observations, 46,790 low‐density lipoprotein cholesterol [LDL‐C] measurements, 3499 participants). A two‐compartment disposition model with parallel linear and Michaelis–Menten elimination and an indirect response model was used to characterize the population PK and LDL‐C response of bococizumab. Potential model parameters and covariate relationships were explored, and visual predictive checks were used for model assessment and validation. Key covariates included the effect of anti‐drug antibodies (ADAs) on exposure through impact on clearance and bioavailability; impact of statins on bococizumab elimination (maximal rate of metabolism); and impact of statins, Asian race, and male sex on LDL‐C efficacy (maximum effect). ADAs and neutralizing ADAs did not have additional effects on LDL‐C beyond the influence on bococizumab exposure. In conclusion, the population PK/PD model adequately describes bococizumab concentration and LDL‐C efficacy. The covariate effects are consistent with the presumed mechanism of action of PCSK9 inhibitors. With increasing availability of antibody‐based therapeutics, improved understanding of the effect of ADAs and statins on bococizumab PK/PD adds to the literature and enhances our pharmacological understanding of how immunogenicity and concomitant medications may impact the PK/PD of biotherapeutics.

News (Medical) associated with Bococizumab

28 Jul 2021

·www.globenewswire.com

Alkahest Strengthens Management Team with Addition of César

SAN CARLOS, Calif., July 28, 2021 (GLOBE NEWSWIRE) -- Alkahest, Inc., a clinical-stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases and a subsidiary of Grifols, today announced the appointment of Dr. César Cerezo M.D., Ph.D., as chief medical officer. He will be responsible for leading and providing strategic direction to the clinical development and medical teams. “Dr. Cerezo brings to Alkahest robust and broad experience both as a practicing and research physician, and as an experienced pharmaceutical and biotechnology industry leader. Having played a significant role in the advancement of multiple clinical development programs across different therapeutic areas at esteemed companies such as Amgen and Pfizer, we are confident that César will provide invaluable leadership and strategic insight to the continued development of Alkahest’s exciting portfolio of clinical candidates for age-related disease,” said Karoly Nikolich, Ph.D., chairman of the board of directors and chief executive officer of Alkahest. “We warmly welcome Dr. Cerezo to Alkahest as the chief medical officer and look forward to the clinical progress that his oversight and strategic acumen will bring to our team.” César Cerezo, chief medical officer of Alkahest, added: “I am pleased to join this passionate and innovative team during such an exciting time for its clinical pipeline, as the Company initiates and completes additional clinical programs to support its unique approach to treating disease. Through the development of a promising new class therapeutics focused on targeting the plasma proteome, Alkahest has established itself as leader in reimagining the way we treat age-related disease, and I am eager to begin working with the Alkahest team to propel clinical growth and strategy.” Prior to joining Alkahest, Dr. Cerezo served as Vice President and Therapeutic Area Head of Global Medical Affairs General Medicine at Amgen, in which he led the global and U.S. medical organizations across Amgen’s Cardiovascular/Metabolic, Bone, Nephrology, Neuroscience, Inflammation and Biosimilars divisions, overseeing strategies and execution of Medical plans for over 20 in-line and pipeline programs. Prior to this position, Dr. Cerezo held multiple leadership roles, including U.S. and Global Medical Lead of the Repatha program and additional cardio-metabolic portfolio programs at various stages of the development lifecycle. Prior to his time at Amgen, Dr. Cerezo held numerous roles of increasing responsibility at Pfizer, where he was the Senior Director of Global Medical Affairs for the Bococizumab program before becoming Global Medical Team Leader for Eliquis. Prior to joining the pharmaceutical industry, Dr. Cerezo was in clinical practice for over 15 years in different internal medicine units. In his last seven years he was a member of a specialized cardiovascular and renal unit, in which he served as a researcher and a practitioner, publishing and lecturing in multiple scientific relevant journals and forums. He also worked as a professor in clinical pharmacology, semiology, and epidemiology at European University in Madrid. César earned his M.D. in Medicine and Surgery from Complutense University in Madrid, Spain in 1998 and completed a residency in Family and Community medicine in 2002. He received his Ph.D. in cardiovascular disease from Autonoma University in Madrid in 2012, where his thesis focused on chronic renin-angiotensin system suppression effect on the albumin urinary excretion in patients with arterial hypertension. César also holds a specialist degree in vascular risk prevention from Complutense University in Madrid. For more information, please visit or . About Grifols Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services that are sold in more than 100 countries. Pioneers in the plasma industry, Grifols operates a growing network of donation centers worldwide. It transforms collected plasma into essential medicines to treat chronic, rare and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion. In addition, the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with nearly 24,000 employees in 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership. In 2020, Grifols’ economic impact in its core countries of operation was EUR 7.5 billion. The company also generated 140,000 jobs, including indirect and induced. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). Alkahest is a clinical stage biopharmaceutical company dedicated to discovering and developing treatments for neurodegenerative and age-related diseases with transformative therapies targeting the aging plasma proteome. The Alkahest pipeline includes multiple therapeutic candidates ranging from selected plasma fractions to protein-targeted interventions which aim to slow the detrimental biological processes of aging. For more information, please visit or . Media ContactMichael TattoryLifeSci Communications1 (646) 751-4362mtattory@lifescicomms.com Grifols Media Press Officemedia@grifols.com Tel. +34 571 00 02 LEGAL DISCLAIMERThe facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.

Biosimilar

17 Jul 2017

·www.biospace.com

3 Tiny Biotechs Packed With Top Execs With Proven Track Records

July 17, 2017 By Mark Terry , BioSpace.com Breaking News Staff Because biotech companies face a litany of regulatory challenges, an experienced business leader or team of leaders can make all the difference between success and failure. Todd Campbell, writing for The Motley Fool , takes a look at three biotech companies that have the advantage of proven leaders. 1. Aurinia Pharmaceuticals Headquartered in Victoria, British Columbia, Aurinia ( AUPH ) is focused on developing voclosporin for lupus nephritis (LN). In mid-June, the company presented data from its global Phase IIB AURA-LV study in lupus at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrin, Spain. The data showed that the low-dose voclosporin statistically improved efficacy over the control arm at both 24 and 48 weeks, and doubled remission rates at 48 weeks compared to the control arm. The company’s chief executive officer and chairman is also a founder, Richard Glickman . He was co-founder, chairman and chief executive of Aspreva Pharmaceuticals ( ASPV ), and played an integral role in developing CellCept, or MMF, as the standard of care for lupus nephritis. Aspreva was bought by Galenica in 2008 for almost $1 billion. Campbell writes, “Aurinia Pharmaceuticals’ C-suite is packed with ex-Aspreva Pharmaceuticals executives who know a thing or two about lupus nephritis (LN)…. A Phase III study that could confirm its Phase II findings is already under way, with a completion date of 2020. If the trial’s a success, Glickman and his crew estimate voclosporin’s market opportunity could be $1 billion in the United States alone. Given that this company’s market cap is only $530 million, betting that this management team will succeed again could be profit-friendly.” Aurinia are currently trading for $7.02. 2. Axovant Sciences Based in Basel, Switzerland, Axovant Sciences was founded by multiple start guru Vivek Ramaswamy , who also launched Myovant and Roivant Sciences , and others. Axovant acquired initepirdine for mild-to-moderate Alzheimer’s disease for $5 billion from GlaxoSmithKline . In a Phase IIb trial, it’s shown a favorable safety and tolerability profile, with immediate and sustained efficacy over placebo. Topline results from its MINSET trial in 1,315 patients on a stable background therapy of donepezil (Aricept) are expected in late September 2017. In April, David Hung joined the company as chief executive officer. Hung was the founder, president and chief executive officer of Medivation until it was acquired by Pfizer in September 2016 for $14 billion. Campbell notes that Hung isn’t the only top exec at Axovant. “While the odds are stacked against it,” he writes, “Axovant Sciences’ management is one big reason investors might not want to bet on a failure. Its chief development officer is Lawrence Friedhoff , who beat the odds once before, when he developed Aricept, one of the globe’s most commonly used Alzheimer’s disease drugs.” Axovant are currently trading for $24.87. 3. Esperion Therapeutics Located in Ann Arbor, Michigan, Esperion is focused on developing a cholesterol drug. Campbell has argued before that Pfizer might consider acquiring Esperion. The rationale is that Pfizer had spent plenty of money on developing a new type of cholesterol medication, a PCSK9 inhibitor, called bococizumab, which functions differently than statins. And Pfizer’s Lipitor is a statin. There are PCSK9 inhibitors on the market, Amgen (AMGN)’s Repatha and Regeneron Pharmaceuticals and Sanofi ’s Praluent. However, bococizumab had some safety risks that led to Pfizer shuttering the program. Esperion, however, is developing another cholesterol drug that uses yet another mechanism of action. Its lead candidate is bempedoic acid. It is an oral drug and can be taken along with statins. Esperion’s founder is Roger Newton , who led the team that developed Lipitor at Warner-Lambert . After leaving Warner-Lambert, he started a biotech company in 1998 called (confusingly) Esperion Therapeutics , what might be considered Esperion 1.0. It produced positive results on a cholesterol drug, which Newton then sold to Pfizer for $1.3 billion in 2003. In 2008, Newton then launched the current Esperion, what might be dubbed Esperion 2.0, and recruited many of his former team from Esperion 1.0. Campbell notes, “In Phase II trials, pairing bempedoic acid up with statins reduced bad cholesterol by an additional 20 percent. Results from Esperion Therapeutics’ Phase III study are expected next year, and if they’re good, Newton may strike it rich in this indication yet again. Given his track record already, I’m not betting against him.” Esperion are currently trading for $49.01.

Clinical ResultPhase 2AcquisitionPhase 3Executive Change

03 Apr 2017

·www.biospace.com

Bristol-Myers Squibb Who? Why Pfizer Could be Making Googly Eyes at This Michigan Biotech Instead

April 3, 2017 By Mark Terry , BioSpace.com Breaking News Staff Rumors that Pfizer (PFE) might acquire Bristol-Myers Squibb rose again recently, after a research note to investors by Credit Suisse analyst Vamil Divan brought it up. Based on comments Pfizer’s executive team have made, it seems likely that Pfizer is in acquisition mode. Todd Campbell, writing for The Motley Fool , makes a case that Pfizer should look to acquire Ann Arbor, Mich.-based Esperion Therapeutics . All About Cholesterol Campbell’s argument revolves around Pfizer’s Lipitor, the best-selling cholesterol drug in the world. The first of the drug’s patents expired in 2010, allowing generic competition. At least partly in response to that, Pfizer spent a lot of money and resources on developing a PCSK9 inhibitor called bococizumab. PCSK9 inhibitors function differently than statins, and Lipitor is a statin. So far, there are two PCSK9 inhibitors on the market, Amgen ’s Repatha and Regeneron and Sanofi ’s Praluent. Campbell writes, “Although Pfizer’s program was trailing, management thought it could still capture significant share if a cardiovascular-outcomes trial showed that bococizumab safely lowered the risk of heart attack, stroke, or death in cardiovascular disease patients. Unfortunately, the company announced last fall that a review of the data instead revealed safety risks that were significant enough for Pfizer to shut down the study.” Esperion Therapeutics This is why Campbell thinks Pfizer should take a look at Esperion, which is developing another cholesterol medicine that uses yet another mechanism of action. Its lead candidate is bempedoic acid, which is an oral formulation, and can be taken along with statins. In mid-stage clinical trials, bempedoic acid and statins combined improved bad cholesterol levels by an additional 20 percent. The drug is now in Phase III clinical studies, with data expected sometime next year. The company is also investigating whether, in addition to improving cholesterol levels, the drug decreases the risk of major cardiac events such as heart attacks and stroke, as well as death. In addition to the strategic nature of an Esperion acquisition, Pfizer already has a previous relationship with the company (which is slightly confusing). The founder of Esperion is Roger Newton . He led the team that developed Lipitor at Warner-Lambert . After leaving Warner-Lambert, Newton launched a biotech company in 1998 called—here’s where the confusion comes in—Esperion Therapeutics. What Campbell refers to as Esperion 1.0, reported positive results on a cholesterol drug, and Newton sold the company to—you guessed it—Pfizer for $1.3 billion in 2003. Then in 2008, Newton created the current Esperion, what Campbell calls Esperion 2.0 . He recruited many of his former team from Esperion 1.0 . And that’s how they came up with bempedoic acid. Bristol-Myers Squibb is Expensive Any deal involving Bristol-Myers would likely cost around $100 billion. There aren’t many companies that could afford that large a deal, but Pfizer is one of them. Pfizer hasn’t been shy about taking shots at mega-mergers like the failed acquisition of Allergan . And at least part of Credit Suisse ’s recent focus on Pfizer and Bristol-Myers Squibb is due to activist investor Carl Icahn taking a stake in Bristol-Myers in February, and another activist investor, Jana Partners , acquiring a stake in the last quarter of 2016. At least some of the thinking is that BMS would make a great takeover target. Campbell notes that, “Only Pfizer knows its M&A plans, and Esperion Therapeutics might not be for sale anyways. Nevertheless, Esperion’s team has a track record that’s M&A-friendly, and bempedoic acid’s potential market opportunity is big enough that it could interest a player like Pfizer.”

AcquisitionPhase 3Clinical Result

100 Deals associated with Bococizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10621	Bococizumab	-	DB12456

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypercholesterolemia	Phase 3	China	Pfizer Inc.	31 Oct 2016
Dyslipidemias	Phase 3	United States	Pfizer Inc.	01 Aug 2016
HIV Infections	Phase 3	United States	Pfizer Inc.	01 Aug 2016
Ischemic stroke	Phase 3	United States	Pfizer Inc.	29 Oct 2013
Ischemic stroke	Phase 3	United States	Huizhi Pharmaceutical (Dalian) Co., Ltd.	29 Oct 2013
Ischemic stroke	Phase 3	Argentina	Pfizer Inc.	29 Oct 2013
Ischemic stroke	Phase 3	Argentina	Huizhi Pharmaceutical (Dalian) Co., Ltd.	29 Oct 2013
Ischemic stroke	Phase 3	Australia	Huizhi Pharmaceutical (Dalian) Co., Ltd.	29 Oct 2013
Ischemic stroke	Phase 3	Australia	Pfizer Inc.	29 Oct 2013
Ischemic stroke	Phase 3	Belgium	Pfizer Inc.	29 Oct 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SPIRE 1 and 2 (ESC2019)	Not Applicable	-	-	Bococizumab	rtmhoslsfn(hklgsuthal) = kfcubnncda fvzowkmfuw (jkckbfcanl )	-	03 Sep 2019
NCT02524106 (B-HIVE, CTgov)	Phase 3	Cardiovascular Diseases \| Dyslipidemias \| HIV Infections	11	Bococizumab (Bococizumab)	kjisbnqcxa(sczsztstsg) = bdxgjeaxrp ersbiyqmtd (whipffrlwo, kmzjtdowvu - tskbuoyvdx) View more	-	19 Jun 2019
				Placebo (Placebo)	kjisbnqcxa(sczsztstsg) = lkvplusksy ersbiyqmtd (whipffrlwo, wypmgijhzg - ogpenaoslb) View more
NCT02043301 (CTgov)	Phase 1	Hypercholesterolemia	75	Bococizumab (Bococizumab 150 mg Abdomen)	xyntswjueg(mifeaostrd) = onqumxqhtt blmljvfypi (vvfnkrcpaw, 53) View more	-	31 May 2019
				Bococizumab (Bococizumab 150 mg Thigh)	xyntswjueg(mifeaostrd) = odhgvmnmct blmljvfypi (vvfnkrcpaw, 30) View more
NCT02055976 (CTgov)	Phase 2	Hypercholesterolemia	218	Atorvastatin+PF-04950615 (Atorvastatin + PF-04950615 50 mg)	blwgktrwbp(ksidrsghyw) = uqzbkzergf byagreiclg (iwoeszwfwd, 15.748) View more	-	08 Feb 2019
				Atorvastatin+PF-04950615 (Atorvastatin + PF-04950615 100 mg)	blwgktrwbp(ksidrsghyw) = vwnloslwij byagreiclg (iwoeszwfwd, 18.769) View more
NCT01243151 (CTgov)	Phase 1	Hypercholesterolemia	68	placebo+PF-04950615 (Placebo)	uhyadxxjkr = nngbjycmcw yrgkyxravn (giwhzmfqbs, relwuylzdz - itxhllsxrk) View more	-	22 Jan 2019
				PF-04950615 (PF-04950615 0.25 mg/kg)	uhyadxxjkr = advlkezohb yrgkyxravn (giwhzmfqbs, wcqxrhuglt - ikqjjxfhji) View more
NCT01435382 (CTgov)	Phase 1	Hypercholesterolemia	49	PF-04950615 (PF-04950615 IV 200 mg)	ukgjddpfdt(cetcutfeyl) = jojqmaoltp vwgsuczusg (jkkdswfgpu, 14047) View more	-	23 Jul 2018
				PF-04950615 (PF-04950615 SC 200 mg (2 Injections of 1 mL))	ukgjddpfdt(cetcutfeyl) = otsardhxgu vwgsuczusg (jkkdswfgpu, 18289) View more
NCT01975389 (SPIRE-2, CTgov)	Phase 3	Cardiovascular Diseases	10,564	Placebo (Placebo)	uaskxoqoln = uptqfmnxkf khzbnahgmf (tnbkafhlfo, sccqksktib - ukcyoqjrlp) View more	-	12 Jun 2018
				bococizumab (PF-04950615) (Bococizumab (PF-04950615))	uaskxoqoln = vvcbxennwx khzbnahgmf (tnbkafhlfo, cigzysvemj - aeskyehwgd) View more
NCT01975376 (SPIRE-1, CTgov)	Phase 3	Cardiovascular Diseases	16,784	Placebo (Placebo)	mevavaaobl = spmiclesbi drfpjhtvvp (pevdjxtzxc, btkkyfvkhu - bymzjvydno) View more	-	12 Jun 2018
				bococizumab (PF-04950615) (Bococizumab (PF-04950615))	mevavaaobl = vuvquujaxk drfpjhtvvp (pevdjxtzxc, mrkzvigkyc - xdklnzyogn) View more
NCT02458287 (SPIRE-AI, CTgov)	Phase 3	Primary Hyperlipidemia \| Hyperlipidemia, Familial Combined	299	Placebo+Bococizumab (Placebo Matched to Bococizumab 150 mg)	azsqojeszx(inbrgoalew) = ndblvdlgnt rfqmgqtkoi (azppezvryv, 3.57) View more	-	19 Dec 2017
				Bococizumab (Bococizumab 150 mg)	azsqojeszx(inbrgoalew) = yjsmwhvxzx rfqmgqtkoi (azppezvryv, 2.57) View more
NCT02135029 (SPIRE-SI, CTgov)	Phase 3	Hyperlipidemias	184	Placebo for Bococizumab (PF-04950615;RN316)	tzfrkopotc(hjapspqyco) = exrzuomlcd phtufzutzc (dtailugegg, 12.86) View more	-	14 Dec 2017

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