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]

NCT02667223

/ TerminatedPhase 1

A Phase 1, Open Label, Randomized, Single Dose, Dose Escalation Study To Assess The Subcutaneous Pharmacokinetics And Pharmacodynamics Of Bococizumab (pf 04950615) Alone And In Co Mixture With Recombinant Human Hyaluronidase (rhuph20, Pf 06744547) In Healthy And Hypercholesterolemic Adult Subjects

This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single subcutaneous injection. Subjects will remain confined at the research clinic for approximately 2 days. After discharge, subjects will return to the research clinic 15 times during 12 weeks.

Start Date01 Feb 2016

Sponsor / Collaborator

Pfizer Inc.

[+1]

100 Clinical Results associated with Bococizumab

100 Translational Medicine associated with Bococizumab

100 Patents (Medical) associated with Bococizumab

Literatures (Medical) associated with Bococizumab

01 Jul 2025·Open Heart

PCSK9 targeting therapies for familial hypercholesterolaemia: a meta-analysis of efficacy on lipid biomarkers and safety in adults and children across 23 RCTs

Review

Author: Giorgi, Juliana ; Leucker, Thorsten M ; Arrighini, Giang Son ; Walia, Hemank ; Barbagelata, Alejandro ; Ho, Vinh Q T ; Nguyen, Nhan ; Downes, David ; Ho, Tri Huynh Quang ; Tran, Nghi Bao ; Dandamudi, Mrunalini ; Ferrara, Victoria Zecchin

Background:

Familial hypercholesterolaemia (FH) is a hereditary disorder characterised by elevated low-density lipoprotein cholesterol (LDL-C) levels, substantially increasing the risk of atherosclerotic cardiovascular disease. Proprotein convertase subtilisin/kexin type 9 (PCSK9) targeting therapies, including monoclonal antibodies and small interfering RNA (siRNA) agents, have emerged as effective lipid lowering therapies.

Objective:

To assess the efficacy and safety of PCSK9-targeting therapy on lipid biomarkers and adverse events in patients with FH, compared with placebo on the background of standard lipid-lowering therapy.

Methods:

A systematic review and meta-analysis were conducted, incorporating data from 23 randomised controlled trials involving adult and paediatric FH patients treated with PCSK9 inhibitors (PCSK9i) or siRNA, including alirocumab, bococizumab, evolocumab, tafolecimab and inclisiran. Eligible studies reported changes in LDL-C, apolipoprotein B (ApoB), lipoprotein a (Lp(a)), triglycerides (TGL) and adverse effects. Pooled mean differences (MDs) and ORs with 95% CIs were calculated using random-effects models, and heterogeneity was assessed with I² statistic. This meta-analysis was registered on PROSPERO (CRD42025631510).

Results:

A total of 4282 patients were included. PCSK9-targeting therapies significantly reduced LDL-C levels compared with control therapies (MD=−46.64%; 95% CI −50.77% to –42.52%; p<0.00001) and TGL (MD=−15.18%; 95% CI –19.34% to –11.03%; p<0.00001). Significant reductions were also observed for ApoB (MD=−34.94%; 95% CI –40.89% to –28.99%; p<0.00001) and Lp(a) (MD=−22.7%; 95% CI −25.95% to –19.44%; p<0.00001). LDL-C, TGL and ApoB reduction were more significant in heterozygous FH patients than in homozygous patients. The safety profile of these therapies was favourable, with adverse event rates comparable to those of the controls.

Conclusions:

PCSK9i and Inclisiran demonstrate significant and sustained reductions in LDL-C, ApoB, Lp(a) and TGL in FH patients, especially in heterozygous FH patients. These agents are generally well-tolerated and represent effective treatment options for FH patients inadequately controlled by standard lipid-lowering therapies.

31 Dec 2024·mAbs

Nonclinical immunogenicity risk assessment for knobs-into-holes bispecific IgG ₁ antibodies

Article

Author: Tsai, Wen-Ting K. ; Tran, Peter ; Brumm, Jochen ; Peng, Kun ; Wu, Patrick ; Li, Yinyin ; Phung, Qui ; Cohen, Sivan ; Tam, Sien ; Ye, Zhengmao ; Spiess, Christoph ; Carter, Paul J. ; Qin, Dan ; Wong, Manda ; Yin, Zhaojun ; Zhou, Zhenru

Bispecific antibodies, including bispecific IgG, are emerging as an important new class of antibody therapeutics. As a result, we, as well as others, have developed engineering strategies designed to facilitate the efficient production of bispecific IgG for clinical development. For example, we have extensively used knobs-into-holes (KIH) mutations to facilitate the heterodimerization of antibody heavy chains and more recently Fab mutations to promote cognate heavy/light chain pairing for efficient in vivo assembly of bispecific IgG in single host cells. A panel of related monospecific and bispecific IgG₁ antibodies was constructed and assessed for immunogenicity risk by comparison with benchmark antibodies with known low (Avastin and Herceptin) or high (bococizumab and ATR-107) clinical incidence of anti-drug antibodies. Assay methods used include dendritic cell internalization, T cell proliferation, and T cell epitope identification by in silico prediction and MHC-associated peptide proteomics. Data from each method were considered independently and then together for an overall integrated immunogenicity risk assessment. In toto, these data suggest that the KIH mutations and in vitro assembly of half antibodies do not represent a major risk for immunogenicity of bispecific IgG₁, nor do the Fab mutations used for efficient in vivo assembly of bispecifics in single host cells. Comparable or slightly higher immunogenicity risk assessment data were obtained for research-grade preparations of trastuzumab and bevacizumab versus Herceptin and Avastin, respectively. These data provide experimental support for the common practice of using research-grade preparations of IgG₁ as surrogates for immunogenicity risk assessment of their corresponding pharmaceutical counterparts.

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 ; Honda, Masaki ; Kubo, Chiyomi ; 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.

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

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperlipidemia, Familial Combined	Phase 3	China	Pfizer Inc.	31 Oct 2016
Atherosclerosis	Phase 3	United States	Pfizer Inc.	01 Aug 2016
Carotid Stenosis	Phase 3	United States	Pfizer Inc.	01 Aug 2016
Coronary Artery Disease	Phase 3	United States	Pfizer Inc.	01 Aug 2016
Dyslipidemias	Phase 3	United States	Pfizer Inc.	01 Aug 2016
HIV Infections	Phase 3	United States	Pfizer Inc.	01 Aug 2016
Hypertension	Phase 3	United States	Pfizer Inc.	01 Aug 2016
Peripheral Arterial Disease	Phase 3	United States	Pfizer Inc.	01 Aug 2016
Cardiovascular Diseases	Phase 3	Chile	Pfizer Inc.	29 Oct 2013
Cardiovascular Diseases	Phase 3	India	Pfizer Inc.	29 Oct 2013

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02524106 (B-HIVE, CTgov)	Phase 3	Cardiovascular Diseases \| Coronary Artery Disease \| Dyslipidemias ... View more	11	Bococizumab (Bococizumab)	zqkfniwxdy(bzvbyiegop) = ywsdzilkyj xzrdwykpty (ufbjeorrte, iwvfivmrpp - zkhjmspgik) View more	-	19 Jun 2019
				Placebo (Placebo)	zqkfniwxdy(bzvbyiegop) = tctwplzbxe xzrdwykpty (ufbjeorrte, pfagofyccg - sdlofpkkxd) View more
NCT02043301 (CTgov)	Phase 1	Hypercholesterolemia	75	Bococizumab (Bococizumab 150 mg Abdomen)	ujevlmntmd(dnevoanpua) = hoiescsedp fqemnwljcg (fhhtvsktih, 53) View more	-	31 May 2019
				Bococizumab (Bococizumab 150 mg Thigh)	ujevlmntmd(dnevoanpua) = eqshphbjas fqemnwljcg (fhhtvsktih, 30) View more
NCT02055976 (CTgov)	Phase 2	Hypercholesterolemia	218	Atorvastatin+PF-04950615 (Atorvastatin + PF-04950615 50 mg)	gawrrrmruw(ufvzgnhgzz) = yplyvoufds bkdbrxwfse (zhjpsjbdky, 15.748) View more	-	08 Feb 2019
				Atorvastatin+PF-04950615 (Atorvastatin + PF-04950615 100 mg)	gawrrrmruw(ufvzgnhgzz) = bdiwkuepgm bkdbrxwfse (zhjpsjbdky, 18.769) View more
NCT01243151 (CTgov)	Phase 1	Hypercholesterolemia	68	placebo+PF-04950615 (Placebo)	ytvanpfdea = cmiohmfbby eavojntqpw (pedufnsigy, lblrekhzru - faxtdaybsr) View more	-	22 Jan 2019
				PF-04950615 (PF-04950615 0.25 mg/kg)	ytvanpfdea = xigrtzrkcp eavojntqpw (pedufnsigy, gojigtmhrv - xtecskqfii) View more
NCT02458209 (Pubmed \| Clin Pharmacol Drug Dev)	Phase 1	-	470	PFS using DS manufactured by Pfizer	oxzutoqrjg(yhtnocipkt) = qjtridhxup eilbzbzbfr (auezvvoivw ) View more	-	01 Jan 2019
				PFS using DS manufactured by Boehringer Ingelheim Pharma	oxzutoqrjg(yhtnocipkt) = hxfoalyoev eilbzbzbfr (auezvvoivw ) View more
NCT01435382 (CTgov)	Phase 1	Hypercholesterolemia	49	PF-04950615 (PF-04950615 IV 200 mg)	epfpoeysya(qjvtaxtmng) = dehdczytar gyaxhghscw (talchoezfh, 14047) View more	-	23 Jul 2018
				PF-04950615 (PF-04950615 SC 200 mg (2 Injections of 1 mL))	epfpoeysya(qjvtaxtmng) = lirjdmdfns gyaxhghscw (talchoezfh, 18289) View more
NCT01975376 \| NCT01975389 (SPIRE-1 and SPIRE-2, Pubmed \| Circulation)	Phase 3	Inflammation high sensitivity C-reactive protein (hsCRP) \| LDL-C	9,738	Statin therapy and bococizumab	smnlfuvmxj(pozcbfeiab) = tecknrpref fgagfxjcnr (difkoiezzc, -61.2 to -59.8)	-	10 Jul 2018
NCT01968954 \| NCT01975376 \| NCT01968967 \| NCT01975389 \| NCT01968980 \| NCT02100514 (SPIRE, Pubmed \| J Clin Lipidol)	Phase 3	Hypercholesterolemia, Familial	1,578	bococizumab	qwpnsbgbrc(xsrsclxzry) = ryqyjsbole wykecfyxay (ygipsasvku )	-	01 Jul 2018
				bococizumab	qwpnsbgbrc(xsrsclxzry) = abqexxrggm wykecfyxay (ygipsasvku )
NCT01975389 (SPIRE-2, CTgov)	Phase 3	Cardiovascular Diseases	10,564	Placebo (Placebo)	shudkrtwvx = yhobszurkc wjxixmnfdf (utorexpscr, pusklmjxqb - azewhtfxby) View more	-	12 Jun 2018
				bococizumab (PF-04950615) (Bococizumab (PF-04950615))	shudkrtwvx = ndjtplzuij wjxixmnfdf (utorexpscr, kggjqidghg - txwnnutaxb) View more
NCT01975376 (SPIRE-1, CTgov)	Phase 3	Cardiovascular Diseases	16,784	Placebo (Placebo)	pjxrvxjqun = vdnrdvxpzt dtrrzbmicg (beqzqdluan, xgdgggpbpq - iusdkddiwn) View more	-	12 Jun 2018
				bococizumab (PF-04950615) (Bococizumab (PF-04950615))	pjxrvxjqun = ctttkgmeee dtrrzbmicg (beqzqdluan, mlskdqcygi - uejzfsfvnt) View more

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