Albuminuria

Study Design and Baseline Characteristics of Prespecified, Exploratory Pooled Analysis to Investigate Effect of Finerenone on Cardio-Kidney Outcomes in Patients with CKD and Type 2 Diabetes and/or Heart Failure Shared at Heart Failure 2024 Congress

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星期一, 五月 13, 2024
Research, Diabetes, Clinical Trials, Cardiology, Biotechnology, Other Health, Health, Pharmaceutical, Science, Type 2 diabetes, Patient, LVEF, HF, Finerenone, Heart failure, ESC, FACP, Chronic kidney disease, CKM, CKD, Albuminuria, Natriuresis, Bayer, EGFR, Glomerular filtration rate, History, Pharmaceutical industry

The study design and baseline characteristics of FINE-HEART, a new prespecified, exploratory pooled analysis of three Phase III trials with finerenone1, were presented today as a Late-Breaking Science Session at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC) in Lisbon.

Key Points: 
  • The study design and baseline characteristics of FINE-HEART, a new prespecified, exploratory pooled analysis of three Phase III trials with finerenone1, were presented today as a Late-Breaking Science Session at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC) in Lisbon.
  • Finerenone is marketed as Kerendia® and approved for the treatment of adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 70 countries worldwide, including the United States.
  • The data presented here may discuss a use outside of the approved indication.
  • FINE-HEART is designed to investigate the effects of finerenone on cardio-kidney outcomes based on data from over 19,000 patients with varying combinations of heart failure (HF), CKD and T2D across three Phase III finerenone studies – FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF.1
    Over 92% of patients included in the analysis had overlapping cardio-kidney-metabolic (CKM) conditions—78% had two (HF and CKD, HF and T2D or CKD and T2D), while 14.7% had all three.

Lexicon Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update

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星期四, 五月 2, 2024
Shift, FDA, Albuminuria, Investment, Research, Webcast, Chronic kidney disease, Endothelium, PROGRESS, American College of Cardiology, ASN, ID, AAK1, Overalls, Heart failure, Treatment, Conference, HCM, Neuropathic pain, Quality of life, Diabetes, Patient, SGLT2 inhibitor, Travel, Diabetic ketoacidosis, Obesity, CKD, Marketing, Research and development, American College, Vessel, Insulin, Diabetes management, Inhibitor, NDA, Coagulation, Administration, Society, Lexicon, Risk, Growth, Lexicon Pharmaceuticals, Pharmaceutical industry

Net sales for the quarter were $1.1 million reflecting 63 percent growth from the previous quarter.

Key Points: 
  • Net sales for the quarter were $1.1 million reflecting 63 percent growth from the previous quarter.
  • Lexicon is initiating a Phase 3 study of sotagliflozin in HCM, with an expected study start mid-year 2024.
  • Results from Two Large US Integrated Health System
    Revenues: Revenues for the first quarter of 2024 were $1.1 million, primarily from the commercialization of INPEFA.
  • Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update.

Skye Announces Clinical Development Plan in Obesity for Differentiated Peripheral CB1 Inhibitor, Nimacimab

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星期一, 十二月 11, 2023
GIP, NAFLD, Traffic barrier, Cholesterol, Food, Șaeș, IND, Non-alcoholic fatty liver disease, Drug discovery, FDA, Kidney disease, Weight loss, Syringe, Trial of the century, Half-life, Obesity, Investigational New Drug, Chronic kidney disease, OTCQB, CNS, CB1, Biomarker, Prediabetes, Central nervous system, Patient, Safety, Albuminuria, Pharmaceutical industry

SAN DIEGO, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye"), a pharmaceutical company developing drugs targeting the endocannabinoid system, announced today that it plans to develop nimacimab, the Company’s monoclonal antibody recently acquired from Bird Rock Bio, for weight loss and the treatment of obesity. The Company has filed an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for the initiation of a Phase 2 clinical study of nimacimab in patients with obesity and chronic kidney disease.

Key Points: 
  • Nimacimab is a negative-allosteric modulating antibody targeting the cannabinoid 1 receptor ("CB1"), which has been implicated as an important target in multiple cardiometabolic diseases including obesity and renal complications.
  • Obesity and kidney disease are highly correlated: 80% of patients who have kidney disease are also obese; 30% of obese patients have kidney disease.
  • Nimacimab effectively inhibits CB1 signaling and, based on preclinical and early clinical studies, is devoid of the CNS liabilities typically seen by small molecule drugs that target the CB1 receptor because it does not cross the blood-brain barrier.
  • Skye owns the worldwide rights to nimacimab, with patents issued in the U.S. and other territories including claims to cannabinoid 1 receptor antibodies with inverse agonist function.

ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT®) for Diabetic CKD and Provides Corporate Updates

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星期一, 十一月 13, 2023
Chronic kidney disease, Webcast, QP, Renal replacement therapy, GMP, Specialization, International, Physician, Kidney failure, Kidney disease, CVS Health, Risk, Surgeon, Glomerular filtration rate, Data, Patient, Framingham Heart Study, Dialysis, CKD, Boston University, Internal medicine, Baxter International, Albuminuria, Documentation, Health, Nephrology, Business administration, Conference, REACT, Trial of the century, EGFR, Quality of life, Memorial University of Newfoundland, Kellogg School of Management, Commercialization, Medical device, Pharmaceutical industry, Cryptocurrency

Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients.

Key Points: 
  • Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients.
  • Updated interim REACT RMCL-002 study data support continued investigation of REACT’s potential to benefit patients with moderate and high-risk diabetic CKD.
  • The ongoing Phase 2 clinical study assessed adverse events and changes in kidney function as measured by estimated glomerular filtration rate (eGFR), as primary study endpoints.
  • Further, you may listen to the presentation by dialing 1-877-407-0784 (US) or 1-201-689-8560 (International) and entering the Conference ID: 13742672.

Maze Therapeutics Announces Initiation of Dosing in Phase 1 Trial Evaluating MZE829, a Novel Oral APOL1 Inhibitor, as a Potential Treatment for APOL1 Kidney Disease

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星期四, 十二月 14, 2023
Stem Cells, Biotechnology, Pharmaceutical, General Health, Health, Genetics, Clinical Trials, Other Health, Chronic kidney disease, Black, Drug, Research, Safety, APOL1, Therapy, Kidney, Pathology, Kidney disease, Risk, Patient, Pharmacokinetics, Albuminuria, Drug discovery, Human, L1, Pharmaceutical industry, Maze

Maze Therapeutics, a company translating genetic insights into new precision medicines, today announced the initiation of dosing in the company’s Phase 1 trial of MZE829 in healthy volunteers.

Key Points: 
  • Maze Therapeutics, a company translating genetic insights into new precision medicines, today announced the initiation of dosing in the company’s Phase 1 trial of MZE829 in healthy volunteers.
  • MZE829 is an oral, small molecule apolipoprotein L1 (APOL1) inhibitor designed to block APOL1 pore function and ameliorate manifestations of APOL1 kidney disease.
  • Genetic variants of the gene (G1 and G2) are associated with increased risk for a spectrum of progressive kidney diseases in the Black community.
  • Maze anticipates reporting data from the trial in the second half of 2024 to support advancement into the Phase 2 clinical program in patients.

Mineralys Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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星期二, 十一月 7, 2023
JAMA, Nissen, Insurance, BP, Obesity, Biotechnology, American Medical Association, Blood pressure, Treatment, American Heart Association, Uncontrolled, Albuminuria, Conference, Journal, R, Poster, Society, Chronic kidney disease, Cleveland, ASN, Hypertension, Research and development, Medicare Part D, CKD, Safety, AHA, Therapy, Patient, Investment, Cleveland Clinic, Administration, Conference call, Pharmaceutical industry, Cryptocurrency, Part

RADNOR, Pa., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the quarter ending September 30, 2023, and provided a corporate update.

Key Points: 
  • ET –
    RADNOR, Pa., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the quarter ending September 30, 2023, and provided a corporate update.
  • Research and Development (R&D) expenses were $22.5 million for the quarter ended September 30, 2023, compared to $6.1 million for the quarter ended September 30, 2022.
  • General and Administrative (G&A) expenses were $3.8 million for the quarter ended September 30, 2023, compared to $1.4 million for the quarter ended September 30, 2022.
  • Net loss was $22.8 million for the quarter ended September 30, 2023, compared to $6.7 million for the quarter ended September 30, 2022.

Maze Therapeutics Highlights New Preclinical Data Supporting Advancement of APOL1 Inhibitor Candidate Toward Clinical Evaluation for APOL1 Kidney Disease

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星期六, 十一月 4, 2023
Stem Cells, Biotechnology, Pharmaceutical, General Health, Health, Genetics, Clinical Trials, Other Health, Kidney, Apolipoprotein L1, Biomarker, APOL1, Human, Pathology, Albuminuria, APOL, Research, Society, Acute kidney injury, Medicine, Risk, Kidney disease, Therapy, Pharmaceutical industry, Maze

Maze Therapeutics, a company translating genetic insights into new precision medicines, today announced findings from preclinical studies demonstrating the potential of a novel APOL1 inhibitor to reverse disease manifestations of APOL1 kidney disease in a chronic APOL1 kidney disease mouse model.

Key Points: 
  • Maze Therapeutics, a company translating genetic insights into new precision medicines, today announced findings from preclinical studies demonstrating the potential of a novel APOL1 inhibitor to reverse disease manifestations of APOL1 kidney disease in a chronic APOL1 kidney disease mouse model.
  • The data are being presented today during a poster session at the American Society of Nephrology Kidney Week 2023 in Philadelphia.
  • “Leveraging our Maze Compass™ platform, our scientists have been able to uncover a more robust understanding of APOL1 kidney disease that gives us confidence in our approach to inhibiting APOL1 with an oral, small molecule.
  • Based on these findings, Maze plans to evaluate development candidate MZE829 as a treatment for APOL1 kidney disease with a Phase 1 healthy volunteer trial expected to begin by the end of 2023.

Zibotentan/dapagliflozin combination demonstrated significant albuminuria reduction in patients with chronic kidney disease and proteinuria in ZENITH-CKD Phase IIb trial

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星期五, 十一月 3, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, UACR, Phase, Albuminuria, Medical imaging, Medical device

Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Key Points: 
  • Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
  • Zibotentan in combination with dapagliflozin compared to dapagliflozin alone in patients with chronic kidney disease: A randomised active-controlled clinical trial.
  • Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial.
  • Burden of Chronic Kidney Disease by KDIGO Categories of Glomerular Filtration Rate and Albuminuria: A Systematic Review.

Boehringer Ingelheim achieves major milestone in chronic kidney disease: aldosterone synthase inhibitor on top of empagliflozin delivers promising results in Phase II trial

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星期五, 十一月 3, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Standard of care, University of Washington School of Medicine, Hyperkalemia, Oxford, Pressure, Albuminuria, SGLT2, Kidney, HIV disease progression rates, Society, American Society of Nephrology, Population 1 (album), Chronic kidney disease, Phase, Boehringer Ingelheim, Clinical trial, ASN, Hypertension, Aldosterone, Risk, Kidney disease, University, Serum, ASI, CKD, Safety, End organ damage, Patient, Ingelheim am Rhein, Pharmaceutical industry, UACR, Medicine

Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi).

Key Points: 
  • Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi).
  • “With over 1 billion people worldwide affected by these conditions, the potential to help reduce the pressure on healthcare systems and patients is immense.
  • We are proud to be leading the way in this field and are excited to move forward with the upcoming Phase III trial to further investigate the potential of this novel compound on top of standard of care including empagliflozin."
  • Hyperkalemia occurred at a rate typical for a CKD population,1 and most episodes did not require medical treatment or BI 690517 discontinuation.1

Only 40% of Diabetes Patients Get Recommended Kidney Health Testing

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星期三, 八月 30, 2023
Blood pressure, Heart, NCQA, CMS, Healthcare Effectiveness Data and Information Set, KED, American Diabetes Association, Chronic kidney disease, Education, Face, HEDIS, Centers for Medicare & Medicaid Services, Microalbuminuria, Public, Health information management, EGFR, Glomerular filtration rate, Research, Mayo Clinic Proceedings, CMO, Kidney, Doctor of Philosophy, Quality, Medicare, National Committee, MD, Patient, NKF, Risk, Albuminuria, Quality assurance, National Kidney Foundation, Diagnosis, CKD, ADA, Kidney disease, National Committee for Quality Assurance, Pharmaceutical industry, Medical device, Dietary supplement, Diabetes

NEW YORK, Aug. 30, 2023 /PRNewswire/ -- Not enough diabetes patients are getting their recommended kidney health screenings, according to a new study by the National Kidney Foundation (NKF) and the National Committee for Quality Assurance (NCQA).

Key Points: 
  • NEW YORK, Aug. 30, 2023 /PRNewswire/ -- Not enough diabetes patients are getting their recommended kidney health screenings, according to a new study by the National Kidney Foundation (NKF) and the National Committee for Quality Assurance (NCQA).
  • "Kidney health testing is pivotal to ensuring timely diagnosis & equitable treatment of CKD," said Dr. Vassalotti, CMO
    According to new data published in Mayo Clinic Proceedings: Innovations, Quality & Outcomes journal, less than 40% of patients with diabetes have been recommended at least annual kidney health screening tests.
  • NKF is calling on health professionals to prioritize kidney health screening for individuals with diabetes which is pivotal to ensuring timely diagnosis and equitable treatment of CKD.
  • "Kidney health testing is pivotal to ensuring timely diagnosis and equitable treatment of CKD," added Joseph Vassalotti, MD, NKF Chief Medical Officer.