Glomerulosclerosis

Aiosyn Launches Kidney Image Analysis Services Through Its NephroPath Platform to Accelerate Drug Development Studies

Retrieved on: 
Thursday, February 29, 2024
Software, Research, Pharmaceutical, Medical Devices, Technology, Hospitals, Artificial Intelligence, Health Technology, Clinical Trials, Science, Biotechnology, Health, Algorithm, Glomerulosclerosis, Multimedia, AI, Pathology, Drug development, Data, ARM Cortex-M, CKD, Biomarker, ChromeOS, Kidney disease, Artery, Kidney, Mortality, Chronic kidney disease, Cancer, Medical imaging

Aiosyn , a pioneering medical software company specializing in AI-powered pathology solutions for cancer and kidney disease, announced the introduction of its NephroPath platform .

Key Points: 
  • Aiosyn , a pioneering medical software company specializing in AI-powered pathology solutions for cancer and kidney disease, announced the introduction of its NephroPath platform .
  • By partnering with Aiosyn, CROs, biopharma, and researchers can accelerate the development of Chronic Kidney Disease (CKD) therapies using new and quantitative insights offered through Nephropath’s Kidney Image Analysis Services .
  • Through Nephropath’s Kidney Image Analysis Services, Aiosyn offers whole kidney quantification and custom kidney analyses.
  • “Using Aiosyn's NephroPath platform we provide researchers with a new and powerful technique to complement the CKD drug development toolbox,” said Patrick de Boer, CEO of Aiosyn.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Tuesday, November 7, 2023
Science, Glomerulosclerosis, B-cell activating factor, DSM-IV codes, Ramipril, Biomarker, Rare, Budesonide, EGFR, Kidney, Person, CD23, Fibrosis, GALT, ACE, Protein, Society, American Society of Nephrology, BAFF, CD30, Urine, ASN, Record, Serum, CET, NOX, Immunoglobulin A, CALT, Histology, Patient, CD27, Alport syndrome, Pharmaceutical industry, Vaccine, IgA nephropathy, Publication, Alport

The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.

Key Points: 
  • The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.
  • The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug.
  • Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points.
  • Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Tuesday, November 7, 2023
Science, Glomerulosclerosis, B-cell activating factor, DSM-IV codes, Ramipril, Biomarker, Rare, Budesonide, EGFR, Kidney, Person, CD23, Fibrosis, GALT, ACE, Protein, Society, American Society of Nephrology, BAFF, CD30, Urine, ASN, Record, Serum, CET, NOX, Immunoglobulin A, CALT, Histology, Patient, CD27, Alport syndrome, Pharmaceutical industry, Vaccine, IgA nephropathy, Publication, Alport

The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.

Key Points: 
  • The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.
  • The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug.
  • Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points.
  • Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation.

ZyVersa Therapeutics Announces a Publication in the Peer-Reviewed Journal, Aging, Linking Inflammasome NLRP3 Activation with Age-Related Structural Changes in the Kidney and Reduced Kidney Function

Retrieved on: 
Wednesday, October 18, 2023
ASC, Hypertrophy, Kidney, Inflammation, Research, Journal, Mouse, Enlargement, Chronic kidney disease, Glomerulosclerosis, Disease, Kidney disease, Focal segmental glomerulosclerosis, Scar, Genetic distance, Podocyte, Therapy, FSGS, Inflammasome, Glomerulus, Super Meat Boy, Pharmaceutical industry, Ageing, NLRP3

Age-related inflammasome signaling and its effects are compounded in the presence of kidney disease, leading to poorer outcomes.

Key Points: 
  • Age-related inflammasome signaling and its effects are compounded in the presence of kidney disease, leading to poorer outcomes.
  • 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.
  • Data demonstrate a critical role for NLRP3 inflammasomes in age-related kidney deterioration, which is exacerbated in the presence of kidney disease.
  • NLRP3 inflammasome signaling and its effects on podocytes may be a critical contributor to a lower threshold for developing kidney disease in older people.

ZyVersa Therapeutics Announces Article Published in Metabolism Pointing to Glomerular Cholesterol Accumulation as Key Factor Exacerbating Renal Injury and Dysfunction in Diabetic Kidney Disease

Retrieved on: 
Monday, May 15, 2023
Cell death, Metabolism, Urine, Structural Damage, FSGS, Type 2 diabetes, Inflammation, Glomerulosclerosis, Proteinuria, Fibrosis, Super Meat Boy, VAR, Patient, Focal segmental glomerulosclerosis, Apoptosis, Kidney, DKD, Diabetic nephropathy, Cholesterol, Therapy, ABCA1, Alport syndrome, Kidney disease, Pharmaceutical industry

In the paper titled, “ABCA1 deficiency-mediated glomerular cholesterol accumulation exacerbates glomerular endothelial injury and dysfunction in diabetic kidney disease,” the authors reported that ABCA1 deficiency contributes to injury and dysfunction of the kidney’s filtration system (glomerular endothelium) in early diabetic kidney disease (“DKD”).

Key Points: 
  • In the paper titled, “ABCA1 deficiency-mediated glomerular cholesterol accumulation exacerbates glomerular endothelial injury and dysfunction in diabetic kidney disease,” the authors reported that ABCA1 deficiency contributes to injury and dysfunction of the kidney’s filtration system (glomerular endothelium) in early diabetic kidney disease (“DKD”).
  • They proposed that ABCA1 transporter deficiency results in glomerular cholesterol/lipid accumulation leading to inflammation and cell death.
  • This causes structural and functional damage to the kidney’s filtration system and in turn, protein spillage into the urine (proteinuria) and DKD progression.
  • The authors concluded that therapies which effectively reduce elevated glomerular cholesterol levels have potential to combat early DKD.

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.

Travere Therapeutics Announces Presentations and Posters at American Society of Nephrology Kidney Week 2022

Retrieved on: 
Wednesday, October 26, 2022
ETAR, Company, American Society of Nephrology, Society, NASDAQ, Immunoglobulin A, Safety, OLE, UK National Kidney Federation, Orange County Convention Center, Proteinuria, Irbesartan, Date, Patient, Chronic kidney disease, Focal segmental glomerulosclerosis, DUET, Glomerulosclerosis, ASN, Heart Protection Study, GLOBE, Therapy, HIV disease progression rates, Association, SAN, Date-time group, II, Caregiver, Podocyte, Pharmaceutical industry, Communications satellite, FSGS, IgA nephropathy

ASN Kidney Week 2022 is being held November 3-6, 2022, in Orlando, Florida.

Key Points: 
  • ASN Kidney Week 2022 is being held November 3-6, 2022, in Orlando, Florida.
  • Location: Session Room: W414 (Orange County Convention Center, West Building)
    Date & Time: November 4, 2022, from 5:15 to 5:24 p.m.
  • Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.
  • After 36 weeks of treatment, 42.0 percent of patients receiving sparsentan achieved FPRE, compared to 26.0 percent of irbesartan-treated patients (p=0.0094).

Travere Therapeutics Provides Regulatory Update on its Sparsentan Program for IgA Nephropathy

Retrieved on: 
Thursday, October 13, 2022
International, PDUFA, Disease, Therapy, Webcast, Chronic kidney disease, Review, New Drug Application, NDA, Prescription Drug User Fee Act, FSGS, Proteinuria, Glomerulosclerosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NASDAQ, Patient, Podocyte, Irbesartan, II, Heart Protection Study, Food, Company, Conference call, Mary Travers, Safety, Immunoglobulin A, GLOBE, REMS, FDA, ETAR, Pharmaceutical industry, Conference, IgA nephropathy

SAN DIEGO, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that following late-cycle review interactions with the U.S. Food and Drug Administration (FDA), the Company expects the previously assigned Prescription Drug User Fee Act (PDUFA) target action date of November 17, 2022 for its New Drug Application (NDA) under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy to be extended by three months.

Key Points: 
  • Many people living with IgA nephropathy continue to face a progression of disease with no currently approved non-immunosuppressive treatments available.
  • Travere Therapeutics will host a conference call and webcast today, October 13, 2022 at 4:30 p.m.
  • Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.
  • The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Travere Therapeutics Provides Regulatory Updates on its Development Programs

Retrieved on: 
Wednesday, August 3, 2022
Chronic kidney disease, Fast Track, Focal segmental glomerulosclerosis, Glomerulosclerosis, HIV disease progression rates, CMA, Food, Patient, Company, Review, Kidney, Jay Traver, NDA, II, Safety, FDA, Maintenance, Program, HCU, Research, Heart Protection Study, Prescription Drug User Fee Act, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Irbesartan, EGFR, GLOBE, Vifor Pharma, New Drug Application, Breakthrough, Breakthrough therapy, Therapy, ETAR, Podocyte, Immunoglobulin A, Proteinuria, NASDAQ, Doctor of Philosophy, Renewable energy, Pharmaceutical industry, PDUFA, FSGS, IgA nephropathy

ET

Key Points: 
  • ET
    SAN DIEGO, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today provided regulatory updates for its sparsentan programs in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS), as well as its pegtibatinase program for classical homocystinuria (HCU).
  • The Company and its partner Vifor Pharma are submitting a Conditional Marketing Authorisation (CMA) application for sparsentan for the treatment of IgAN in Europe.
  • As a result, they are living at high risk of developing long-term, serious complications from disease progression, said Bill Rote, Ph.D., senior vice president of research and development at Travere Therapeutics.
  • At Travere Therapeutics, we are in rare for life.

Travere Therapeutics Announces Presentations of Abstracts at the 59th ERA Congress

Retrieved on: 
Tuesday, May 17, 2022
Disease, Medicine, Food, U.S. Securities and Exchange Commission, Losartan, Form 10-K, EGFR, Podocyte, ERA, Glomerular basement membrane, NDA, Private Securities Litigation Reform Act, Heart Protection Study, II, CMA, Therapy, COVID-19, Patent, SAN, Kidney, GLOBE, Chronic kidney disease, Company, Albuminuria, Focal segmental glomerulosclerosis, FSGS, Priority review, Patient, FDA, Immunoglobulin A, Ongoing reliability test, Congress, Irbesartan, ETAR, Security (finance), Risk, PROTECT, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NASDAQ, Treatment, ARB, Form 10-Q, Caregiver, Life, Safety, Glomerulosclerosis, Development, Pharmaceutical industry, Proteinuria, IgA nephropathy, Glycocalyx

The Company and its collaborators will also present nonclinical data examining the renal protective effects of sparsentan compared to controls.

Key Points: 
  • The Company and its collaborators will also present nonclinical data examining the renal protective effects of sparsentan compared to controls.
  • ERA is being held live in Paris, France, and virtually May 19-22, 2022.
  • In August 2021, the Company announced the PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance.
  • The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.