Proteinuria

Re-engineering Immune Cells Opens Door to Promising Therapy for Lupus Kidney Inflammation

Retrieved on: 
Tuesday, February 6, 2024
Inflammation, Lupus Research Alliance, Steroid, Cell, Cytokine, Immune system, Proteinuria, Bacteria, Nature Communications, Research, Kidney, Patient, Virus, LRA, Antibody, Lupus nephritis, Protein, Disease, Urine, Smith, Infection, Regulatory T cell, Tissue, SLE, DSM-IV codes, Lupus, Vaccine

NEW YORK, Feb. 6, 2024 /PRNewswire/ -- Research featured in Nature Communications highlights a novel approach that re-engineers a person's own immune cells to suppress the overactive immune system that occurs in lupus nephritis, a serious and potentially life-threatening inflammation of the kidneys. With funding in part from the Lupus Research Alliance (LRA), associate professor Joshua Ooi, Ph.D. and his team at the Centre for Inflammatory Disease, Monash Health in Australia, developed an innovative method that could enable multiple targeted therapies not only for lupus but other autoimmune diseases as well.

Key Points: 
  • T cells direct the immune system's response to potential threats by identifying and attacking harmful invaders like viruses and bacteria.
  • In healthy individuals, a specific type of T cells called T regulatory cells (Tregs) prevent the immune system from continuing to react once an infection is cleared.
  • Earlier LRA funding allowed my team to pursue the idea that patients' immune cells could be engineered to correct immune dysfunction.
  • The Lupus Innovation Award then gave us the ability to test the effectiveness of these patient-derived engineered cells in a model of disease."

Labcorp Launches New Test for Risk Assessment and Prognosis of Severe Preeclampsia in Pregnant Women

Retrieved on: 
Wednesday, January 31, 2024
Hypertension, Mortality, Parent, Pregnancy, Senior, TIME, Proteinuria, LH, Risk assessment, Disease, Biomarker, Patient, FDA, Physician, United, Thermo Fisher Scientific, Invention, Time (magazine), Risk, Pre-eclampsia, Health, Serum, Blood pressure, Hospital, Dietary supplement

BURLINGTON, N.C., Jan. 31, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the launch and availability of a new, FDA-cleared blood test for risk assessment and clinical management of severe preeclampsia, a life-threatening blood pressure disorder that occurs during pregnancy and the postpartum period.

Key Points: 
  • The test result, a ratio of these two biomarkers, in conjunction with other laboratory tests and clinical assessments, helps clinicians identify which patients hospitalized for hypertensive disorders of pregnancy may be at risk of progressing to severe features of preeclampsia within the next two weeks of the test.
  • This was validated by the PRAECIS study, which examined more than 1,000 pregnant women across 18 hospitals in the U.S.3
    The blood-based test is intended for use in singleton pregnancies between 23+0 and 34+6/7 weeks gestation.
  • Pregnant women who test positive based on the risk stratification sFlt-1/PlGF ratio ≥ 40, along with other indicators of disease, can receive enhanced surveillance and accelerated care before severe features develop.
  • "Labcorp is proud to partner with Thermo Fisher to offer this new test, which is used in the second and third trimester of pregnancy to assess patients hospitalized for hypertensive disorders and offers providers early and objective information to assist in the management of preeclampsia," said Marcia Eisenberg, Ph.D., Senior Vice President and Chief Scientific Officer at Labcorp.

ZyVersa Therapeutics’ CEO, Stephen C. Glover, Featured on Benzinga All Access

Retrieved on: 
Wednesday, January 10, 2024
Entrepreneurship, Patient, Therapy, Proteinuria, Diabetic nephropathy, Toxicology, GLP, Interview, Structural Damage, Initial public offering, Kidney disease, Environment, Optimism, IND, Inflammasome, Inflammation, VAR, Investigational New Drug, DKD, Pharmaceutical industry

During the interview, Mr. Glover described the significant unmet need and market opportunity in kidney disease, and how ZyVersa’s Cholesterol Efflux MediatorTM VAR 200 has the potential to improve kidney function and reduce kidney disease progression.

Key Points: 
  • During the interview, Mr. Glover described the significant unmet need and market opportunity in kidney disease, and how ZyVersa’s Cholesterol Efflux MediatorTM VAR 200 has the potential to improve kidney function and reduce kidney disease progression.
  • Current treatments target glomerular hypertension and inflammation, but there are no treatments that target lipid accumulation, which is known to contribute to structural damage, proteinuria, and progression of kidney disease.
  • ZyVersa plans to initiate a Phase 2a trial with VAR 200 in patients with diabetic kidney disease (DKD) in the first quarter of 2024, with preliminary data anticipated by mid-year 2024.
  • ZyVersa plans to complete GLP toxicology studies with IC 100 and submit an Investigational New Drug (IND) application in the fourth quarter of 2024, followed by initiation of a Phase 1 trial.

Vera Therapeutics to Host In-Person R&D Day in New York to Present Week 72 Data from Phase 2b ORIGIN Clinical Trial of Atacicept in IgAN on January 25, 2024

Retrieved on: 
Monday, January 8, 2024
Therapy, IgA nephropathy, Patient, University, EGFR, Immunoglobulin A, FRCP, Stanford University Medical Center, Proteinuria, FACP

BRISBANE, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced it will host an in-person R&D day featuring Richard Lafayette, M.D., FACP, from Stanford University Medical Center, who will join company management to present Phase 2b eGFR and proteinuria data from week 72 of the ORIGIN Phase 2b clinical trial of atacicept for the treatment of IgA nephropathy (IgAN), and Jonathan Barratt, Ph.D., FRCP, from the University of Leicester for a discussion of the results, on January 25, 2024.

Key Points: 
  • BRISBANE, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced it will host an in-person R&D day featuring Richard Lafayette, M.D., FACP, from Stanford University Medical Center, who will join company management to present Phase 2b eGFR and proteinuria data from week 72 of the ORIGIN Phase 2b clinical trial of atacicept for the treatment of IgA nephropathy (IgAN), and Jonathan Barratt, Ph.D., FRCP, from the University of Leicester for a discussion of the results, on January 25, 2024.
  • To register, click here.

Travere Therapeutics Provides Corporate Update and 2024 Outlook

Retrieved on: 
Monday, January 8, 2024
CMA, Risk, Shanda, FDA, Plasma, UPCR, European, FSGS, Disease, Education, Therapy, New Drug Application, Kidney disease, CSL Vifor, Proteinuria, SPARTAN, CHMP, HCU, Growth, Committee, Patient, Safety, Diagnosis, Conditional, Pharmaceutical industry

SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) --  Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that, based on preliminary and unaudited financial data, the Company expects net product sales from continuing operations for the fourth quarter of 2023 to be approximately $40 million. For the fiscal year 2023, the Company expects net product sales from continuing operations to be approximately $128 million. The Company ended 2023 with approximately $567 million in cash, cash equivalents, and marketable securities which is expected to support operations into 2028. The Company also provided an update on key corporate, clinical, and regulatory development initiatives, including anticipated milestones for 2024.

Key Points: 
  • For the fiscal year 2023, the Company expects net product sales from continuing operations to be approximately $128 million.
  • The Company also provided an update on key corporate, clinical, and regulatory development initiatives, including anticipated milestones for 2024.
  • "Our strong fourth quarter results reflect the growing demand for FILSPARI in IgAN driven by our field teams’ education and outreach efforts to healthcare providers,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics.
  • The Company expects to announce complete full year 2023 financial results and provide a corporate update in February.

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Marketing, Hypothyroidism, INN, Woman, Progression-free survival, Nausea, Syndrome, Heart, Cancer, Inflammation, Skull, Proteinuria, Anatomy, Cell division, IIA, Diarrhea, Fatigue, ATC, Capsule, Bleeding, Pancreas, RET, VEGF, FGFR, Cerebral edema, Neoplasm, Stroke, Enzyme, Liver failure, Safety, Kidney cancer, Arthralgia, Heart failure, Patient, Urine, Medical Subject Headings, Stomatitis, Immune system, Everolimus, International, Encephalopathy, Language, Somatic symptom disorder, Blood, Mouth, Catherine Disher, Select, Medicine, Vomiting, Pembrolizumab, Cholesterol, PDGF, Kidney failure, Weight loss, Headache, KIT, Brain, Acral lentiginous melanoma, Swelling, Hypoesthesia, Splenic infarction, Confusion, European Medicines Agency, RCC, Kidney, Growth, Sunitinib, Hypercholesterolemia, Rash, Medical device

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Use of SGLT2 Inhibitors Continues to Expand for the Treatment of Chronic Kidney Disease, with Eli Lilly/Boehringer Ingelheim’s Jardiance Making Significant Strides Following Label Expansion

Retrieved on: 
Wednesday, January 3, 2024
Kidney, MRAS, AstraZeneca, Physician, Kidney disease, DMC, Nephrology, Weight loss, Prevalence, BMI, FLOW, Bayer, Diabetic nephropathy, Novo Nordisk, Chronic kidney disease, Proteinuria, Data monitoring committee, Patient, Obesity, MRA, DKD, ACE, SGLT2, Dialysis, CKD, Pharmaceutical industry

As the landscape grows more competitive, their role will be crucial in determining the success of brands like Farxiga and Jardiance.

Key Points: 
  • As the landscape grows more competitive, their role will be crucial in determining the success of brands like Farxiga and Jardiance.
  • This unique positioning compared to other agents was swiftly recognized by nephrologists, prompting them to express a clear preference for the brand.
  • Since the label expansion of Eli Lilly/Boehringer Ingelheim's Jardiance to include CKD, nephrologists have rapidly embraced this drug for both their DKD and non-diabetic CKD patients.
  • Several of these agents, including SGLT2 inhibitors and Kerendia, have demonstrated their effectiveness in slowing the progression of CKD.

ZyVersa Therapeutics CEO, Stephen C. Glover, Issues Letter to Shareholders Providing Outlook for 2024

Retrieved on: 
Wednesday, January 3, 2024
Alport syndrome, Quality of life, Entrepreneurship, Inflammasome, NLRP1, Survival, IND, VAR, Letter, Kidney disease, Inflammation, FSGS, AIM2, Health, Human, Therapy, Clinical trial, Diabetic nephropathy, Focal segmental glomerulosclerosis, Kidney, Proteinuria, NLRP3, DKD, ACE, Optimism, SGLT2, Patient, Capital, Fibrosis, Dialysis, Environment, Pharmaceutical industry

Combined, our two proprietary product platforms target a global total addressable market of around $75 billion.

Key Points: 
  • Combined, our two proprietary product platforms target a global total addressable market of around $75 billion.
  • On the financial front, various market watchers are seeing signals that the biotech and pharma investment environment is set to trend positively in 2024.
  • Capital is again starting to flow to companies that are seeking to innovate through differentiated technologies or novel mechanisms of action.
  • We look forward to embarking on what we believe will be a productive 2024.

Travere Completes Successful pre-NDA Meeting for FILSPARI in IgAN; Provides Regulatory Updates for both IgAN and FSGS

Retrieved on: 
Monday, December 4, 2023
Workforce, Depreciation, Food, Nephrology, Immunoglobulin A, Shanda, FDA, SAN, Therapy, Focal segmental glomerulosclerosis, New Drug Application, Proteinuria, HCU, EGFR, Pharmaceutical industry

SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced the completion of a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan) in IgA nephropathy (IgAN). The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. accelerated approval of FILSPARI to full approval. The Company also completed regulatory engagement on focal segmental glomerulosclerosis (FSGS) in which the FDA communicated that the Phase 3 DUPLEX Study results alone are not sufficient to support an sNDA submission for an FSGS indication for sparsentan. As a result, the Company will be conducting additional analyses of FSGS data with plans to re-engage FDA in 2024, and is implementing a strategic reorganization in Q4 2023 to focus near-term resources on the ongoing FILSPARI launch in IgAN and the advancement of pegtibatinase in classical homocystinuria (HCU).

Key Points: 
  • The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. accelerated approval of FILSPARI to full approval.
  • “Following a successful pre-NDA meeting, we are pleased to be moving forward with our planned sNDA submission for full approval of FILSPARI in IgA nephropathy.
  • “Unfortunately, there is uncertainty around a regulatory path forward for FSGS.
  • Together with $634.6 million in cash and cash equivalents as of September 30, 2023, the Company expects to have a cash runway into 2028.

Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

Retrieved on: 
Tuesday, December 26, 2023
Hyperphosphatemia, Quality of life, Immunotherapy, Immune system, Klebsiella pneumoniae, FDA, PD-1, Renal cell carcinoma, Research, Bladder cancer, TKI, Cancer, Clinical trial, Pseudomonas aeruginosa, Acinetobacter baumannii, Chronic kidney disease, Phosphorus, Kidney disease, NMPA, BCG, Proteinuria, Escherichia coli, Kidney, Edema, National Medical Products Administration, Patient, Drug resistance, CKD, Dialysis, Gram-negative bacteria, Pharmaceutical industry

On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.

Key Points: 
  • On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.
  • Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year.
  • On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema.
  • On December 12, FDA has approved a clinical trial for JMKX000197 to treat BCG-unresponsive non-muscle-invasive bladder cancer, and earlier on October 19, NMPA has approved the clinical trial.