Acute kidney injury

Aurinia Presents Breadth of Data from AURORA Clinical Program Underscoring Value of LUPKYNISⓇ (voclosporin) for Patients with Lupus Nephritis at ACR 2023

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Health, Science, Research, Clinical Trials, Patient, Lupus nephritis, Week, American College, CNI, EGFR, Human, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., TAC, AURORA, Safety, University of California, CSA, VCS, Lupus, Society, Mouse, Acute kidney injury, Ciclosporin, Division, Clinical trial, Efficacy, Physiology, Biopsy, MMF, University, Tacrolimus, Glucocorticoid, ACR, Conditional sentence, Proteinuria, Lithium toxicity, Pharmaceutical industry, Rheumatology, Black, ALMS, Aurinia, Medicine, UPCR, LN

Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.

Key Points: 
  • Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.
  • In AURORA 1, patients received LUPKYNIS® 23.7 mg BID in combination with MMF (target dose 2 g/day) and oral glucocorticoids (starting dose of 25 mg/day tapered to 2.5 mg/day by Week 16).
  • The data showed an improved safety profile over the first six months of treatment with LUPKYNIS® in combination with low-dose glucocorticoids and lower-dose MMF without compromising efficacy.
  • Additional data assessed the disposition of cyclosporine (CSA), tacrolimus (TAC), and voclosporin (VCS) in mouse kidneys relative to its systemic drug exposure.

ZyVersa Therapeutics Announces Article in Peer-Reviewed Journal, Ecotoxicology and Environmental Safety, Linking Air Pollution with Development and Progression of Chronic Kidney Disease That Can Be Attenuated by Inhibiting Inflammasome NLRP3 Activation

Retrieved on: 
Monday, November 6, 2023
Inflammasome, Policy, Biomass, Inflammation, ASC, Kidney, NLRP3, Air pollution, Research, Journal, Security, Chronic kidney disease, Acute kidney injury, Cell death, Particulates, Kidney disease, Therapy, Super Meat Boy, Disability, Fire, Pyroptosis, Pharmaceutical industry, Vaccine, Ecotoxicology

ZyVersa is developing Inflammasome ASC Inhibitor IC 100 which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation.

Key Points: 
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation.
  • Inhibiting the inflammasome NLRP3 pathway, including downstream caspase-1, rescued the kidneys from PM2.5-induced cell death.
  • The authors stated, “We further provided evidence that NLRP3-mediated pyroptosis plays critical roles in the progression of kidney injury induced by PM2.5 exposure.
  • Inhibiting the activation of NLRP3 inflammasome can remarkably protect the renal tubular epithelial cells from PM2.5-induced proptosis.” To read the article, Click Here .

XORTX Sponsored Study Presented at the American Society of Nephrology – Kidney Week 2023

Retrieved on: 
Thursday, November 2, 2023
Uric acid, Session, University of Colorado Colorado Springs, ADPKD, Xanthine oxidase, Polycystic kidney disease, Effect, Cytokine, Research, Society, American Society of Nephrology, Acute kidney injury, PKD, ASN, Hyperuricemia, Kidney disease, University, Diet, Nephrology, Therapy, Patient, Oxipurinol, Pharmaceutical industry, Phosphorus, Prognosis

CALGARY, Alberta, Nov. 02, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the presentation of new research findings at the American Society of Nephrology meeting being held November 3, 2023 in Philadelphia. The abstract entitled "The Effect of Lowering Uric Acid with a Xanthine Oxidase Inhibitor on PKD in Mice” was reviewed by the ASN review panel for scientific merit and novel discoveries. The studies were conducted at the University of Colorado in the independent laboratory of Dr. Charles Edelstein and were sponsored by XORTX. The studies will be presented at Kidney Week during the Session Title: Genetic Diseases: Cystic - Therapeutic Investigations and Prognosis, November 2, 2023.

Key Points: 
  • The studies were conducted at the University of Colorado in the independent laboratory of Dr. Charles Edelstein and were sponsored by XORTX.
  • The studies will be presented at Kidney Week during the Session Title: Genetic Diseases: Cystic - Therapeutic Investigations and Prognosis, November 2, 2023.
  • This poster reports amalgamated results of studies in either rat and mouse models of polycystic kidney disease (“PKD”) challenged with low to moderate circulating uric acid.
  • The effect of increased uric acid on cyst growth – kidney size - and kidney function, as well as inflammatory markers was measured.

Nuwellis’ Strategic Partner, SeaStar Medical, Receives FDA Approvable Letter for Its Pediatric Selective Cytopheretic Device

Retrieved on: 
Tuesday, October 31, 2023
FDA, HDE, Food, SCD, MD, Acute kidney injury, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, AKI, Dialysis, Immune system, SeaStar, Intensive care medicine, CKRT, Letter, Hospice and palliative medicine, Sepsis, End organ damage, Patient, Label, Failure, Pharmaceutical industry

MINNEAPOLIS, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its strategic partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its pediatric Selective Cytopheretic Device (SCD-PED).

Key Points: 
  • MINNEAPOLIS, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its strategic partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its pediatric Selective Cytopheretic Device (SCD-PED).
  • The Approvable Letter indicates that SeaStar Medical’s Humanitarian Device Exemption (HDE) application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization.
  • For the SCD-PED, these include revisions to product labeling and minor modifications to the post-approval study plan.
  • Nuwellis and SeaStar Medical previously announced an exclusive U.S. license and distribution agreement for Nuwellis to distribute the SCD-PED.

PaxMedica Acquires Suramin Research Assets from Rediscovery Life Sciences to Accelerate NDA Submission for PAX-101

Retrieved on: 
Tuesday, October 31, 2023
FDA, IBN, African trypanosomiasis, CMC, Acquisition, Acute kidney injury, Research, Chronic kidney disease, Suramin, DSM-IV codes, NDA, RLS, Pharmaceutical industry

TARRYTOWN, New York, Oct. 31, 2023 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica , Inc. (Nasdaq: PXMD ), a pioneering biopharmaceutical company specializing in cutting-edge treatments for neurological disorders, announced today the successful acquisition of certain suramin research assets from Rediscovery Life Sciences (RLS).

Key Points: 
  • TARRYTOWN, New York, Oct. 31, 2023 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica , Inc. (Nasdaq: PXMD ), a pioneering biopharmaceutical company specializing in cutting-edge treatments for neurological disorders, announced today the successful acquisition of certain suramin research assets from Rediscovery Life Sciences (RLS).
  • These assets were previously dedicated to the study of suramin's potential efficacy in treating acute kidney injury resulting from chronic kidney disease.
  • The integration of the valuable data from Rediscovery Life Sciences will serve as a complementary component in the planned submission for the NDA, further solidifying the company's progression toward this critical milestone.
  • In a recent statement, Howard Weisman , Chairman and CEO of PaxMedica, emphasized the significance of this acquisition, stating, "Acquiring the research assets from Rediscovery Life Sciences marks a significant leap forward in our journey to expedite the NDA submission process for PAX-101.

FDA Issues Approvable Letter for SeaStar Medical’s Selective Cytopheretic Device for Pediatric Patients

Retrieved on: 
Monday, October 30, 2023
FDA, Standard of care, Center for Biologics Evaluation and Research, HDE, Humanitarian Device Exemption, Food, SCD, Mortality, MD, Acute kidney injury, Inflammation, AKI, Hepatorenal syndrome, Dialysis, Cardiorenal syndrome, SeaStar, Intensive care medicine, CKRT, Letter, Neutrophil, Hospice and palliative medicine, Monocyte, Sepsis, Patient, Label, Infection, ICU, Pharmaceutical industry, Medical device, Research

As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.

Key Points: 
  • As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.
  • The issuance by the FDA of an Approvable Letter is a standard step in the approval process of a Humanitarian Device Exemption (HDE) application.
  • The Approvable Letter indicates that SeaStar Medical’s HDE application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization.
  • The SCD-PED-01 (weight range ≥15 kg) and PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively.

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

Retrieved on: 
Saturday, November 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.

Aurinia Presents Breadth of Data at ASN 2023 Demonstrating Clinical Importance of LUPKYNISⓇ for Managing Lupus Nephritis

Retrieved on: 
Thursday, November 2, 2023
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Patient, Lupus nephritis, National Institutes of Health, CNI, EGFR, Kidney failure, AURORA, Safety, Lupus, Kidney, ALMS, Society, Acute kidney injury, Clinical trial, ASN, MMF, NIH, Histology, Glucocorticoid, UPCR, Conditional sentence, Bangladesh Technical Education Board, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Ohio State University Wexner Medical Center, Proteinuria, Toxic leukoencephalopathy, Pharmaceutical industry, Black, Aurinia, LN

Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.

Key Points: 
  • Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.
  • Activity scores for both arms improved to a similar degree, while the chronicity scores remained stable in both arms.
  • “The results presented at ASN this week demonstrate important clinical and mechanistic findings associated with LUPKYNISⓇ treatment.
  • Following is the complete guide to Aurinia’s presentations at ASN 2023:
    Title: Comparison of dual-immunosuppressive therapy and a voclosporin-based, triple-immunosuppressive regimen for lupus nephritis: a propensity analysis of ALMS and AURORA 1 studies

Mission Therapeutics to Present Abstract at American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Thursday, November 2, 2023
Kidney, Mitophagy, Trial of the century, Mission, Mitochondrion, Therapy, Treatment, DUB, Acute kidney injury, AKI, Society, Risk, Master of Science, Pharmacology, Nephrology, Safety, Patient, American Society of Nephrology, MS, Simulation, Pharmaceutical industry

CAMBRIDGE, England, Nov. 2, 2023 /PRNewswire/ -- Mission Therapeutics ("Mission"), a clinical-stage biotech company developing first-in-class therapeutics targeting mitophagy, today announces that it will present an oral abstract on its experimental drug candidate MTX652 at the American Society of Nephrology's Kidney Week in Philadelphia, from 2-5 November 2023.

Key Points: 
  • CAMBRIDGE, England, Nov. 2, 2023 /PRNewswire/ -- Mission Therapeutics ("Mission"), a clinical-stage biotech company developing first-in-class therapeutics targeting mitophagy, today announces that it will present an oral abstract on its experimental drug candidate MTX652 at the American Society of Nephrology's Kidney Week in Philadelphia, from 2-5 November 2023.
  • Mission Therapeutics is a world leader in discovering and developing novel therapeutics which promote the removal of dysfunctional mitochondria to maintain cell health and function.
  • The American Society of Nephrology is a major organization working toward a goal of a world without kidney diseases and we are excited to have the opportunity to share our progress at this important conference.
  • A Phase II trial of MTX652 in patients at risk of acute kidney injury following cardiac surgery is planned to start in Q1 2024.

Mission Therapeutics to Present Abstract at American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Thursday, November 2, 2023
Kidney, Mitophagy, Trial of the century, Mission, Mitochondrion, Therapy, Treatment, DUB, Acute kidney injury, AKI, Society, Risk, Master of Science, Pharmacology, Nephrology, Safety, Patient, American Society of Nephrology, MS, Simulation, Pharmaceutical industry

CAMBRIDGE, England, Nov. 2, 2023 /PRNewswire/ -- Mission Therapeutics ("Mission"), a clinical-stage biotech company developing first-in-class therapeutics targeting mitophagy, today announces that it will present an oral abstract on its experimental drug candidate MTX652 at the American Society of Nephrology's Kidney Week in Philadelphia, from 2-5 November 2023.

Key Points: 
  • CAMBRIDGE, England, Nov. 2, 2023 /PRNewswire/ -- Mission Therapeutics ("Mission"), a clinical-stage biotech company developing first-in-class therapeutics targeting mitophagy, today announces that it will present an oral abstract on its experimental drug candidate MTX652 at the American Society of Nephrology's Kidney Week in Philadelphia, from 2-5 November 2023.
  • Mission Therapeutics is a world leader in discovering and developing novel therapeutics which promote the removal of dysfunctional mitochondria to maintain cell health and function.
  • The American Society of Nephrology is a major organization working toward a goal of a world without kidney diseases and we are excited to have the opportunity to share our progress at this important conference.
  • A Phase II trial of MTX652 in patients at risk of acute kidney injury following cardiac surgery is planned to start in Q1 2024.