This is a Phase IIa, multi-centre study conducted at 3 sites in Singapore (SGH and NUHS, KTPH). 70 patients with diabetes mellitus (DM) and peripheral arterial disease (PAD) will be randomised in a ratio 1:1 to receive normal saline control or MEDI6570 400mg by monthly subcutaneous injection for 9 months.

Start Date15 Jun 2023

Sponsor / Collaborator

National Heart Centre of Singapore Pte Ltd.

[+3]

NCT04610892 / CompletedPhase 2

A Phase IIB, Randomized, Double Blinded, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants With a Prior Myocardial Infarction and Persistent Inflammation

A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.

Start Date04 Nov 2020

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT03654313 / CompletedPhase 1

A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus.

To evaluate the safety, tolerability, PK and immunogenicity of single and multiple ascending doses of MEDI6570 in subjects with Type 2 Diabetes Mellitus

Start Date28 Sep 2018

Sponsor / Collaborator

MedImmune LLC

100 Clinical Results associated with MEDI-6570

100 Translational Medicine associated with MEDI-6570

100 Patents (Medical) associated with MEDI-6570

Literatures (Medical) associated with MEDI-6570

07 Feb 2023·Journal of the American Heart Association

Lectin‐Like Oxidized Low‐Density Lipoprotein Receptor 1 Inhibition in Type 2 Diabetes: Phase 1 Results

Article

Author: Koren, Michael J. ; Yang, Ye ; George, Richard T. ; Varma, Vijayalakshmi ; Collén, Anna ; Ongstad, Emily L. ; Gupta, Ruchi ; Jones, Christopher ; Karathanasis, Sotirios K. ; Quartino, Angelica L. ; Abuhatzira, Liron ; Goodman, Joanne ; Dubois, Vincent F. S. ; Antoniades, Charalambos ; Sinsakul, Marvin ; Vavere, Andrea L.

BackgroundBlockade of the lectin‐like oxidized low‐density lipoprotein receptor‐1 (LOX‐1) is a potentially attractive mechanism for lowering inflammatory and lipid risk in patients with atherosclerosis. This study aims to assess the safety, tolerability, and target engagement of MEDI6570, a high‐affinity monoclonal blocking antibody to LOX‐1.Methods and Results This phase 1, first‐in‐human, placebo‐controlled study (NCT03654313) randomized 88 patients with type 2 diabetes to receive single ascending doses (10, 30, 90, 250, or 500 mg) or multiple ascending doses (90, 150, or 250 mg once monthly for 3 months) of MEDI6570 or placebo. Primary end point was safety; secondary and exploratory end points included pharmacokinetics, immunogenicity, free soluble LOX‐1 levels, and change in coronary plaque volume. Mean age was 57.6/58.1 years in the single ascending doses/multiple ascending doses groups, 31.3%/62.5% were female, and mean type 2 diabetes duration was 9.7/8.7 years. Incidence of adverse events was similar among cohorts. MEDI6570 exhibited nonlinear pharmacokinetics, with terminal half‐life increasing from 4.6 days (30 mg) to 11.2 days (500 mg), consistent with target‐mediated drug disposition. Dose‐dependent reductions in mean soluble LOX‐1 levels from baseline were observed (>66% at 4 weeks and 71.61–82.96% at 10 weeks in the single ascending doses and multiple ascending doses groups, respectively). After 3 doses, MEDI6570 was associated with nonsignificant regression of noncalcified plaque volume versus placebo (−13.45 mm 3 versus −8.25 mm 3 ). ConclusionsMEDI6570 was well tolerated and demonstrated dose‐dependent soluble LOX‐1 suppression and a pharmacokinetic profile consistent with once‐monthly dosing.Registration URL: https://clinicaltrials.gov/ ; Unique identifier: NCT03654313.

News (Medical) associated with MEDI-6570

25 Apr 2024

·www.fiercebiotech.com

AstraZeneca drops GOLDILOX and the porcupine in R&D update

AstraZeneca kicked MEDI6570 out alongside two partnered phase 1 programs. AstraZeneca’s first-quarter results (PDF) put a twist on a fairy tale, telling the lesser-known story of GOLDILOX and the porcupine. The drugmaker axed a cardiovascular disease prospect after wrapping up the phase 2 GOLDILOX trial while stopping work on early-stage assets bought in from Ionis Pharmaceuticals and Redx Pharma. The drugmaker is locking the three assets away in its tower as part of a strategic portfolio prioritization. MEDI6570, an antibody that blocks ligands to the LOX-1 scavenger receptor, is the most advanced asset affected by the quarterly cull. AstraZeneca took the molecule into a phase 2 trial in 2020 to assess whether it improves outcomes in patients with a history of heart attacks. Having wrapped the study up in November, AstraZeneca removed the asset from its pipeline Thursday. Earlier studies implicated LOX-1 in all the main stages of the buildup of plaque in arteries, but the clinical data have failed to persuade AstraZeneca that the molecule is a good use of its money. Aradhana Sarin, chief financial officer at AstraZeneca, discussed the termination on a media conference call, explaining that the action was based on the company’s “internal evaluation” and was “just part of our normal prioritization process.” AstraZeneca kicked MEDI6570 out alongside two partnered phase 1 programs. The drugmaker picked up the rights to RXC006, a porcupine inhibitor, for fibrotic diseases from Redx for $17 million in near-term payments in 2020. Porcupine is a key enzyme in the Wnt signaling pathway that is implicated in diseases such as idiopathic pulmonary fibrosis. In theory, targeting porcupine could address lung scarring. To test that theory, AstraZeneca ran four phase 1 clinical trials between 2021 and 2023. The drugmaker has said little publicly about what it learned in the studies but has decided it has seen enough and cut the program from its pipeline. The third asset to land on the discard pile is AZD7503, an antisense oligonucleotide AstraZeneca was developing with Ionis. AstraZeneca took the molecule through a series of early-phase trials, culminating in the initiation of a study in people with suspected non-cirrhotic nonalcoholic steatohepatitis in 2023. The liver condition is now known as metabolic dysfunction-associated steatohepatitis (MASH). Ionis designed AZD7503, also known as ION455, to treat MASH by inhibiting production of a protein that is associated with the progression of the condition in mice and humans. Genetic changes in the gene encoding for the protein, HSD17B13, correlate to the occurrence and severity of MASH, but the molecule failed to survive AstraZeneca’s portfolio prioritization.

Phase 1Phase 2Oligonucleotide

25 Apr 2024

·www.biospace.com

Sanofi and AstraZeneca Scrap Several Early-Stage Programs in Q1

Pictured: Exterior of Sanofi's U.S. headquarters in Bridgewater, N.J./ iStock/JHVEPhoto On Thursday, European drugmakers Sanofi and AstraZeneca announced several pipeline cuts in their respective first-quarter 2024 financial results, including assets to treat Sjögren’s syndrome and cardiovascular disease. According to Sanofi’s first-quarter results, the development of the CD40L antibody frexalimab in Sjögren’s syndrome was halted due to unfavorable Phase II study data. While Sanofi touted the safety and “pharmacologic activity” of the drug, the candidate did not reach the “necessary efficacy outcomes” to move forward. However, frexalimab will continue on in Phase III trials in multiple sclerosis (RMS) and secondary-progressive multiple sclerosis (SPMS) as well as Phase II trials in type 1 diabetes and systemic lupus erythematosus. In February 2024, frexalimab secured positive mid-stage results in RMS demonstrating a slowing in disease activity. The drug is also one of Sanofi’s “pipeline-in-a-product” assets that the company contends can potentially generate annual sales of €5 billion ($5.3 billion). Sanofi is also halting a Phase II study of the molecule venglustat to treat the rare genetic disorder GM2 gangliosidosis. The company said there was an “absence of positive trends” for its clinical endpoints in the trial. The molecule aims to slow disease progress by inhibiting the abnormal accumulation of glycosphingolipids. In 2021, Sanofi stopped a Phase II/III trial of venglustat in kidney disease as it did not reach the futility criteria. In neurology, Sanofi discontinued a Phase II study of the RIPK1 inhibitor oditrasertib in amyotrophic lateral sclerosis (ALS) as the trial failed to reach the primary endpoint of improvement based on the ALS Functional Rating Scale-Revised. Sanofi said it will share the complete safety and efficacy data at an upcoming medical meeting and continue the Phase II study of oditrasertib in MS patients. Sanofi’s pipeline cuts come amid announced layoffs last week as part of the company’s restructuring of its U.S. vaccine operations. Thursday’s Q1 earnings also saw AstraZeneca putting the kibosh on several early-stage medicines, including MEDI6570, designed to block multiple ligands to the LOX-1 receptor. The asset was in a Phase IIb trial, called GOLDILOX, for post-myocardial infarction but was stopped due to a “strategic portfolio prioritization.” Other AstraZeneca assets nixed for portfolio prioritization include the metabolic dysfunction-associated steatohepatitis (MASH) candidate AZD7503. The ligand-conjugated antisense (LICA) drug originally belonged to Ionis Pharmaceuticals and is designed to inhibit the production of hydroxysteroid 17-beta dehydrogenase 13 (HSD17B13). The other asset to get axed is the oral porcupine inhibitor AZD5055, which was in Phase I trials for Idiopathic pulmonary fibrosis (IPF) and other Interstitial lung diseases (ILDs) with progressive fibrosis. The candidate was picked up from Redx Pharma in 2020 for $17 million and $360 million, respectively, in potential milestone payments. For Sanofi’s Q1 results, the pharma reported over €10.4 billion ($11.2 billion) in sales, driven by its blockbuster drug Dupixent which increased 24.9% compared to the same period. AstraZeneca meanwhile pulled in $12.1 billion in sales for the quarter, a 15% boost from Q1 of 2023, with its oncology products bringing in more than $5.1 billion, a 23% bump from the previous quarter. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Phase 2Phase 1AcquisitionFinancial StatementClinical Result

26 Jan 2023

·www.prnewswire.com

Myocardial Infarction (MI) Market is Projected to Grow at a Minimal CAGR of 1.61% During the Study Period (2019-2032) | Assesses DelveInsight

Considering the expected launch of new upcoming therapies and greater integration of early patient screening, it can be safely assumed that the MI market will undergo a paradigm shift in the present decade holding new prospects and opportunities for those planning to carve out their niche during the forecast period [2022–2032] LAS VEGAS, Jan. 26, 2023 /PRNewswire/ -- DelveInsight's MI Market Insights report includes a comprehensive understanding of current treatment practices, MI emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. Key Takeaways from the MI Market Report As per DelveInsight analysis, the MI market size in the 7MM was approximately USD 21 billion in 2021 According to the assessment done by DelveInsight, the estimated total MI diagnosed prevalent cases in the 7MM was approximately 15 million in 2021 Leading MI companies such as AstraZeneca, Boehringer Ingelheim and Eli Lilly and Company, Amgen, Novartis, Idorsia Pharmaceuticals, Faraday Pharmaceuticals, CSL Behring, Immediate Therapeutics, Mitsubishi Chemical Group, Kancera, Bayer, Recardio, Mesoblast, and others are developing novel MI drugs that can be available in the MI market in the coming years The promising MI therapies in the pipeline include FARXIGA/FORXIGA (dapagliflozin), JARDIANCE (empagliflozin), Olpasiran (AMG860), Pelacarsen (TQJ230), Selatogrel, FDY-5301, CSL112, IMT-358, CL2020, MEDI6570, KAND567, Asundexian, Dutogliptin, MPC-25-IC , and others In November 2022, Amgen presented end-of-treatment data from its Phase II OCEAN (a)-DOSE study of olpasiran during the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions and simultaneously published in the New England Journal of Medicine As per the Q32022 investor presentation of AstraZeneca data, readouts from the Phase III (DAPA-MI) trial of FARXIGA/FORXIGA is anticipated by 2H 2023. With an estimated key regulatory submission acceptance after 2023 In June 2021, Idorsia announced the initiation of the Phase III registration study "SOS-AMI" to evaluate the efficacy and safety of self-administered SC selatogrel in suspected AMI In September 2020, the FDA granted Fast Track designation for the development of JARDIANCE to prevent hospitalization for heart failure and reduce the risk of mortality in patients with and without diabetes who have had an acute MI In July 2020, AstraZeneca was granted Fast Track designation in the US for the development of FARXIGA to reduce the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults following an AMI or heart attack Discover which therapies are expected to grab the major MI market share @ MI Market Report. MI Overview MI is pathologically defined as myocardial cell death caused by prolonged ischemia. The first ultrastructural changes are diminished cellular glycogen, relaxed myofibrils, and sarcolemmal disruption, which can be seen as early as 10-15 minutes after the onset of ischemia. Symptoms of MI include chest pain, which may initially manifest as a sensation of tightness or pressure. The pain usually radiates to the left arm, but it can also radiate to the lower jaw, neck, right arm, back, and upper abdomen. Sweating, nausea, vomiting, and fainting may accompany chest pain. The typical clinical features, ECG findings, and elevation of cardiac biomarkers are used for MI diagnosis. Cardiovascular catheterization is required for definitive diagnosis and serves diagnostic and therapeutic purposes. All patients suspected of having ACS should be considered for emergency revascularization; other MI treatment options include anticoagulation, antiplatelet therapy, statin therapy, and other adjunctive measures. MI Epidemiology Segmentation DelveInsight estimates that there were approximately 15 million diagnosed prevalent cases of MI in the 7MM in 2021. Among EU4 countries, Germany had the highest number of diagnosed prevalent cases of MI, while Spain had the lowest prevalent population among the 7MM. The MI market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Diagnosed Prevalent Cases Gender-specific Prevalence Type-specific Prevalence Download the report to understand which factors are driving MI epidemiology trends @ MI Epidemiological Insights. MI Treatment Market The goals of initial MI treatment are to relieve pain, immediately identify ST changes via 12-lead EKG, initiate reperfusion (if the patient is a candidate), and assess and treat hemodynamic abnormalities. Oxygen, nitroglycerin, and morphine sulfate are the most effective pain relievers. Reperfusion therapy is indicated for patients with ST-segment elevation or a new LBBB with symptoms lasting 12 hours or less. MI treatment may be divided into two paths depending on whether the patient has a STEMI or an NSTEMI. The pharmacologic MI treatment is further subdivided into several groups of medications that improve survival, reduce recurrent ischemic events, and provide symptomatic relief. Following the primary MI treatment, a multimodal regimen of therapies is used. To classify the disease, rapid diagnostic tests and serial biomarker analysis are used to begin MI treatment. The current MI market has been segmented into different commonly used therapeutic classes based on the prevailing MI treatment pattern across the 7MM, which exhibits minor variations in the overall prescription pattern. The major classes covered in the forecast model are antiplatelet agents, anticoagulants, vasodilators, beta-blockers, lipid-lowering drugs, Angiotensin-converting enzyme (ACE) inhibitors, ARBs (Angiotensin-II receptor Blockers), and calcium channel blockers. In recent years, it has been demonstrated that pre-hospital thrombolysis has a role in the management of patients seen early after symptom onset in comparison/association with patients who had primary coronary intervention or elective primary coronary intervention. This is an important issue that is still being researched to prevent cardiac arrest, large scares, and again limit the transition to heart failure and improve the survival rate after AMI. To know more about MI treatment guidelines, visit @ MI Management. MI Pipeline Therapies and Key Companies FARXIGA/FORXIGA (dapagliflozin): AstraZeneca JARDIANCE (empagliflozin): Boehringer Ingelheim and Eli Lilly and Company Pelacarsen (TQJ230): Novartis Olpasiran: Amgen Selatogrel: Idorsia Pharmaceuticals FDY-5301: Faraday Pharmaceuticals CSL112: CSL Behring IMT-358: Immediate Therapeutics CL2020: Mitsubishi Chemical Group MEDI6570: AstraZeneca KAND567: Kancera Asundexian: Bayer Dutogliptin: Recardio MPC-25-IC: Mesoblast Learn more about the FDA-approved drugs for MI @ Drugs for MI Treatment. MI Market Dynamics The dynamics of MI market is anticipated to change in the coming years. The growing emphasis on secondary preventive measures to avoid recurrent/new events, lifestyle changes, and the growing number of smokers and cases of obesity, diabetes, hypertension, and others, are expected to fuel MI market growth. Moreover, heart attacks and strokes are major cost drivers in the 7MM healthcare system. The volume of the MI market is enormous. The patient is receiving multiple therapies at the same time. The smallest portion of the patient share can provide pharmaceutical companies with options worth millions of dollars in the MI market. However, several factors are likely to affect the growth of the MI market. Women appear to be underdiagnosed with MI, despite being at higher risk because medical training for healthcare professionals and public information has emphasized the identification of symptoms that typically affect men. This highlights the importance of gender differences in developing strategies for early MI detection and tailored secondary prevention after MI, which should result in a higher rate of MI detection in women. Moreover, off-label therapies and generics account for the majority of the current MI market because they are less expensive and more easily accessible to patients, thus, causing a dip in the MI market growth. Hence, all these factors mentioned above will hamper the MI market growth in the future. Scope of the MI Market Report Therapeutic Assessment: MI current marketed and emerging therapies MI Market Dynamics: MI market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, MI Market Access and Reimbursement Discover more about MI drugs in development @ MI Clinical Trials. Table of Contents Related Reports MI Pipeline MI Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key MI companies, including CSL Behring, Immediate Therapeutics, Mitsubishi Chemical Group, Kancera, Bayer, Recardio, among others. MI Epidemiology Forecast MI Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted MI epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Myocarditis Pipeline Myocarditis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myocarditis companies, including Cantargia AB, Cardiol Therapeutics, Apitope, among others. Dilated Cardiomyopathy Pipeline Dilated Cardiomyopathy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key dilated cardiomyopathy companies, including Longeveron, Bristol Myers Squibb, Berlin Cures, Tenaya Therapeutics, Cardior Pharmaceuticals, among others. Cardiac Biomarkers Testing Market Cardiac Biomarkers Testing Market Insight, Competitive Landscape, and Market Forecast – 2027 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key cardiac biomarkers testing companies, including Beckman Coulter, Inc, Siemens Healthcare GmbH, Abbott, among others. Dilated Cardiomyopathy Epidemiology Dilated Cardiomyopathy Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted dilated cardiomyopathy epidemiology in the 7MM. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Blogs Upcoming Cardiovascular Diseases Drugs Key Companies in the Cardiology Segment Heart Failure Market Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Connect with us on: LinkedIn | Facebook | Twitter. Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services. Logo - Contact Us: Shruti Thakur [email protected] +1(919)321-6187 SOURCE DelveInsight Business Research, LLP

Phase 3Fast Track

100 Deals associated with MEDI-6570

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Inflammation	Phase 2	ES	AstraZeneca PLC	04 Nov 2020
Inflammation	Phase 2	GB	AstraZeneca PLC	04 Nov 2020
Inflammation	Phase 2	PL	AstraZeneca PLC	04 Nov 2020
Inflammation	Phase 2	US	AstraZeneca PLC	04 Nov 2020
Inflammation	Phase 2	HU	AstraZeneca PLC	04 Nov 2020
Inflammation	Phase 2	CA	AstraZeneca PLC	04 Nov 2020
Inflammation	Phase 2	NL	AstraZeneca PLC	04 Nov 2020
Inflammation	Phase 2	AU	AstraZeneca PLC	04 Nov 2020
Inflammation	Phase 2	IT	AstraZeneca PLC	04 Nov 2020
Inflammation	Phase 2	CZ	AstraZeneca PLC	04 Nov 2020

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