DKD

ProKidney Announces Publication of Trial Design for Phase 2 Multicenter Clinical Trial of REACT for Late Stage 4 Diabetes-Related Chronic Kidney Disease

Retrieved on: 
Tuesday, January 10, 2023
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WINSTON-SALEM, N.C., Jan. 10, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced the publication of the trial design and early data analysis from REGEN-003, a Phase 2 clinical study of Renal Autologous Cell Therapy (REACT®), in the Journal of Blood Purification. The paper, titled Renal Autologous Cell Therapy (REACT) in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis, was published online and will appear later this year in the print edition of the Journal (DOI: doi.org/10.1159/000527582).

Key Points: 
  • The paper, titled Renal Autologous Cell Therapy (REACT) in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis, was published online and will appear later this year in the print edition of the Journal (DOI: doi.org/10.1159/000527582 ).
  • “This is a high-risk patient population with seriously reduced kidney function.
  • At 15 months, two patients (20%) had preservation of their kidney function and had not advanced to renal replacement therapy.
  • We believe that REACT has the potential to have a significant, positive impact on patients’ health and quality of life.

Renalytix Completes Agreement with Veterans Administration to Integrate KidneyIntelX Testing across all Electronic Health Record systems

Retrieved on: 
Monday, January 9, 2023
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LONDON and SALT LAKE CITY, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced the execution of a Co-operative Research and Development Agreement (CRADA) with the U.S. Veterans Health Administration Innovation Ecosystem (VHA IE) to install the KidneyIntelX solution inside the VA Health System’s Cloud Infrastructure and interface it with the VA Electronic Health Record Systems.

Key Points: 
  • LONDON and SALT LAKE CITY, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced the execution of a Co-operative Research and Development Agreement (CRADA) with the U.S. Veterans Health Administration Innovation Ecosystem (VHA IE) to install the KidneyIntelX solution inside the VA Health System’s Cloud Infrastructure and interface it with the VA Electronic Health Record Systems.
  • By installing the KidneyIntelX platform inside the VA infrastructure through this innovative approach, one of the first such implementations by the VA, the stringent requirements for the security of Veteran’s health information and data will be assured.
  • According to the March 17, 2020, Veterans Health Administration (VHA) Directive 1053, approximately 960,000 Veterans, or 11%, meet the established criteria for chronic kidney disease (CKD).
  • However, less than half of those Veterans, 320,000, or 5%, have been formally diagnosed with CKD.

Journey Biosciences launches NaviDKD™ for people with diabetes to predict long-term kidney complications

Retrieved on: 
Thursday, December 1, 2022
Diagnosis, Kidney disease, Kidney, Compass, Multimedia, Risk, Certification, Biotechnology, DKD, Biomarker, CLIA, Diabetes, LDT, Pharmaceutical industry

LEBANON, N.H., Dec. 1, 2022 /PRNewswire/ -- Journey Biosciences, Inc., a biotechnology company offering biomarker-based predictive risk screening technologies for diabetes-related complications, today announced the launch of its flagship product NaviDKD.

Key Points: 
  • LEBANON, N.H., Dec. 1, 2022 /PRNewswire/ -- Journey Biosciences, Inc. , a biotechnology company offering biomarker-based predictive risk screening technologies for diabetes-related complications, today announced the launch of its flagship product NaviDKD.
  • NaviDKD, a biomarker-based blood test, proactively assesses the risk of kidney disease in people with diabetes years before clinical signs or symptoms appear.
  • Along with its proprietary Compass reporting platform, NaviDKD provides actionable insights for preventing and managing kidney complications before they occur.
  • "For the one-in-three people with diabetes who will develop diabetic kidney disease, NaviDKD provides an opportunity to fundamentally change their ultimate health outcomes," said Adam Graybill, Chief Executive Officer of Journey Biosciences.

Primary Care Use of KidneyIntelX in Early Stage CKD Improved Clinical Care Delivery and Outcomes

Retrieved on: 
Thursday, December 1, 2022
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By integrating a simple, actionable KidneyIntelX risk assessment result, primary care physicians are able to determine the appropriate and cost-effective treatment plan for their individual patients based on their risk level.

Key Points: 
  • By integrating a simple, actionable KidneyIntelX risk assessment result, primary care physicians are able to determine the appropriate and cost-effective treatment plan for their individual patients based on their risk level.
  • The ability to predict CKD risk early could improve care and outcomes by reducing cardiovascular events, hospitalizations and emergency room visits.
  • Medicare alone spends an estimated $85 billion on early stage CKD care each year, more than double the $37 billion spent on end stage kidney disease care.
  • By addressing kidney disease early, providers can better allocate resources and reduce costs across all stages of the disease.

Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

Retrieved on: 
Tuesday, November 29, 2022
Health, Diabetes, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, DN, Doctor of Philosophy, European Renal Association – European Dialysis and Transplant Association, T2D, Metabolic disorder, Conditional sentence, CB1, Kidney disease, Hypertriglyceridemia, DKD, Patient, Fatty liver disease, Diabetic nephropathy, HTG, T1D, NASH, Pancreas, Chronic kidney disease, Disease, Standard of care, Diabetes, Muscle, IPF, Obesity, Liver, Idiopathic pulmonary fibrosis, Pharmaceutical industry, MD

Inversago Pharma Inc. (Inversago), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD).

Key Points: 
  • Inversago Pharma Inc. (Inversago), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD).
  • Participants will receive once-daily oral doses of 10 or 25mg of INV-202 or placebo during the 16-week study.
  • This study builds on positive Phase 1b data that will be presented at a future scientific conference.
  • INV-202 is a small molecule CB1 inverse agonist being developed by Inversago for the potential treatment of a range of cardiometabolic and fibrotic conditions, including diabetic kidney disease.

The World's First ETa-specific Monoclonal Antibody: Gmax Biopharm's GMA131 Approved by the US FDA for Clinical Study on (DKD) Diabetic Kidney Disease

Retrieved on: 
Monday, November 14, 2022
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announced today that its application of investigation of New Drug (IND) for GMA131 injection, the first global ETa-specific monoclonal antibody, was approved by the US FDA on Nov 11, 2022 for clinical study on diabetic kidney disease (DKD).

Key Points: 
  • announced today that its application of investigation of New Drug (IND) for GMA131 injection, the first global ETa-specific monoclonal antibody, was approved by the US FDA on Nov 11, 2022 for clinical study on diabetic kidney disease (DKD).
  • Dr. Shuqian Jing, Founder and Chairman of Gmax Biopharm, said, "GMA131 is the first genuine ETa-specific monoclonal antibody developed by Gmax Biopharm.
  • GMA131 is the same molecule as GMA301 which is currently in a Phase Ib trial of pulmonary arterial hypertension (PAH) in China/USA.
  • DKD, the leading cause of chronic kidney disease and end stage renal disease (ESRD), is one of the most important complications of diabetes.

RheoMeditech to Showcase "Automatic Platelet Function Analyzer (ANYSIS)" and "ESR system (RheoESR)" at MEDICA 2022

Retrieved on: 
Wednesday, November 9, 2022
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SEOUL, South Korea, Nov. 9, 2022 /PRNewswire/ -- MEDICA 2022 takes places from 14-17, November 2022 in Dusseldorf, Germany.

Key Points: 
  • SEOUL, South Korea, Nov. 9, 2022 /PRNewswire/ -- MEDICA 2022 takes places from 14-17, November 2022 in Dusseldorf, Germany.
  • RheoMeditech is currently looking for strategic partners to explore the overseas markets together.
  • ANYSIS system is a platelet function analyzer which can test anti-platelet response and bleeding risk management using four different types of test cartridges Aspirin, P2Y12, ADP, Epinephrine in one device.
  • RheoMeditech is also launching ESR system and is designated to show the RheoESR system for the first time in MEDICA 2022.

Chinook Therapeutics Presents Updated Data from Atrasentan Phase 2 AFFINITY IgA Nephropathy (IgAN) Patient Cohort, Preclinical Atrasentan Research and Ongoing Clinical Trials at the American Society of Nephrology (ASN) Kidney Week 2022

Retrieved on: 
Thursday, November 3, 2022
Blood pressure, RNA, Peripheral edema, Baylor College of Medicine, FSGS, EDT, Investor, Focal segmental glomerulosclerosis, University, FR, ETA, Inflammation, SEC, Proteinuria, Alport syndrome, Program, Treatment, Kidney, Western literature, Pharmacokinetics, Șaeș, GLOBE, Glomerulosclerosis, Fibrosis, MD Anderson Cancer Center, Urine, Nephritis, BNP, Forward-looking statement, Nephrology, Chronic kidney disease, Research, SGLT2, Kidney disease, Webcast, EGFR, COVID-19, RAS, Headache, Primary hyperoxaluria, Randomness, LDHA, Therapy, Acei, Industry, DKD, Biomarker, Conference, Immunoglobulin A, Nasdaq, Standard of care, Gene expression, ACE, Risk, Trial of the century, MD, Silviculture, Liquor, Vaccine, Pharmaceutical industry, Health insurance, Patient, Atrasentan, UPCR, Safety, IgA nephropathy, Chinook

We are encouraged by these results, and look forward to reporting topline proteinuria data from our ongoing phase 3 ALIGN trial in 2023.

Key Points: 
  • We are encouraged by these results, and look forward to reporting topline proteinuria data from our ongoing phase 3 ALIGN trial in 2023.
  • Key highlights from the presentation include the following:
    In the IgAN cohort, median baseline 24-hour urine protein excretion was 1.2 g/day.
  • As of the October 19, 2022 data cutoff, atrasentan was well-tolerated in patients with IgAN, with no treatment-related SAEs.
  • A trial-in-progress overview for the ongoing, global, phase 2, open-label AFFINITY basket study of atrasentan was presented as an informational poster.

KidneyIntelX Clinical Utility and Health Economics Validated in Multiple Data Releases at American Society of Nephrology

Retrieved on: 
Monday, October 17, 2022
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The new model with plasma sTNFR1, sTNFR2, and KIM-1 combined with clinical variables accurately risk-stratified AAs with and without APOL1 risk genotype for kidney outcomes.

Key Points: 
  • The new model with plasma sTNFR1, sTNFR2, and KIM-1 combined with clinical variables accurately risk-stratified AAs with and without APOL1 risk genotype for kidney outcomes.
  • Thursday, November 3, 2022 from 10:00 AM to 12:00 PM at the Exhibit Hall, Orange County Convention Center.
  • Initial results suggest that despite similar median eGFR and median UACR levels, African American patients tested with KidneyIntelX were three times more likely to be scored as high risk.
  • KidneyIntelX has received Breakthrough Device Designation from the U.S. Food and Drug Administration and Renalytix has submitted for De Novo marketing authorization.

Inversago Pharma Announces Appointment of Ed Mathers, BSc and Nanna Lüneborg, PhD, MBA to its Board of Directors

Retrieved on: 
Wednesday, October 19, 2022
Health, Diabetes, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Kidney disease, T2D, IPF, T1D, Socially responsible investing, General partnership, IPO, Patient, United Nations Principles of Medical Ethics, Hypertriglyceridemia, Bachelor of Science, MBA, Fibrosis, Diabetic nephropathy, Investment, EUR, New Enterprise Associates, Technology, HTG, NASH, Initial public offering, CB1, Company, Doctor of Philosophy, Health, DKD, Obesity, Board, NEA, BGV, Fatty liver disease, Board of directors, Progressive, Idiopathic pulmonary fibrosis, Fine chemical, Pharmaceutical industry

It is with great pleasure that I welcome both Ed and Nanna to our Board of Directors at this exciting time for the Company, said Franois Ravenelle, PhD, Chief Executive Officer of Inversago Pharma.

Key Points: 
  • It is with great pleasure that I welcome both Ed and Nanna to our Board of Directors at this exciting time for the Company, said Franois Ravenelle, PhD, Chief Executive Officer of Inversago Pharma.
  • Carlo Incerti, Chairman of the Board of Inversago Pharma, commented: We warmly welcome Ed and Nanna on their timely appointment to our board of directors and look forward to working together with them as the Company prepares for an imminent Phase 2 trial with its lead molecule INV-202.
  • I would also like to extend my appreciation to Tara Nickerson and Dennis Kim for their excellent service to Inversago during their board tenure.
  • For more information about Ed Mathers, Nanna Lneborg and our complete Board of Directors, please visit inversago.com .