Glomerular filtration rate

Alpine Immune Sciences Shares Updated Clinical Data from Povetacicept in IgA Nephropathy

Retrieved on: 
Wednesday, April 10, 2024
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, FDA, Congress, Immunoglobulin G, ALPN, University, Glomerular filtration rate, Proteinuria, Survival, Cytokine, MD, Hematuria, UPCR, Webcast, Immunoglobulin A, EGFR, Disease, Nephrology, Patient, WCN, Alpine, Inflammation, Multimedia, Infection, Biomarker, Exhibition, University of Leicester, Autoimmunity, BAFF, Pharmaceutical industry

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today shared updated clinical data for povetacicept in IgA nephropathy (IgAN) which will be presented as a late breaking poster at the World Congress of Nephrology (WCN) April 13-16, 2024 in Buenos Aires, Argentina.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today shared updated clinical data for povetacicept in IgA nephropathy (IgAN) which will be presented as a late breaking poster at the World Congress of Nephrology (WCN) April 13-16, 2024 in Buenos Aires, Argentina.
  • RUBY-3 is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, where povetacicept is administered subcutaneously (SC) once every four weeks.
  • As of March 01, 2024, 41 patients with IgAN had received povetacicept 80 or 240 mg subcutaneously every 4 weeks.
  • These data strongly support the inhibition of APRIL/BAFF pathways by povetacicept and its efficacy in the treatment of IgAN as well as the need for further clinical development.

Get Your Study Enrolled - Designing Your Impairment Protocol to Prevent Challenges, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Monday, April 22, 2024
MMS, Kidney, University, FASN, Glomerular filtration rate, UNC School of Medicine, Data analysis, MD, GFR, Doctor of Philosophy, Pharmacokinetics, Clinical pharmacology, Project management, Drug development, Associate, Division, Kidney failure, Human body

TORONTO, April 22, 2024 /PRNewswire-PRWeb/ -- As drug development progresses, regulators require clarity on how products are metabolized in the human body, and the risks associated with compounds that may linger in critical organs.

Key Points: 
  • In this free webinar, learn how renal impairment study protocols can be improved to maximize patient enrollment.
  • Making informed decisions about the design of a study protocol is important, as overly complex protocols can quickly narrow the patient population.
  • Therefore, making informed decisions about the design of a study protocol is important, as overly complex protocols can quickly narrow the patient population.
  • Register for this webinar to understand how impairment study protocols can be improved to maximize patient enrollment.

Alport Syndrome Market to Witness Upsurge in Growth at a Massive CAGR of 69% by 2034 | DelveInsight

Retrieved on: 
Wednesday, April 17, 2024
USD, Urine, ACE, Finerenone, ESRD, Kidney, Otorhinolaryngology, Nephrotoxicity, Mutation, Hearing, Diagnosis, Glomerular filtration rate, Hearing loss, Blood, Swelling, Proteinuria, Kidney failure, Cochlea, Alport syndrome, Nephrology, EU4, GFR, ADAS, Heredity, Research, Genetic counseling, Kidney disease, Novartis, ARAS, Ophthalmology, COL4A4, Patient, Kidney transplantation, LAS, Dialysis, DSM-IV codes, COL4A3, Quality of life, Genetic disorder, Gene, Pharmaceutical industry

LAS VEGAS, April 17, 2024 /PRNewswire/ -- DelveInsight's Alport Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, Alport syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Key Points: 
  • Leading Alport syndrome companies such as Eloxx Pharmaceuticals, Chinook Therapeutics (A Novartis company), Bayer, Calliditas Therapeutics, Evotec, and others are developing novel Alport syndrome drugs that can be available in the Alport syndrome market in the coming years.
  • The disorder manifests in different forms such as autosomal recessive Alport syndrome (ARAS), X-linked Alport syndrome (XLAS), and autosomal dominant Alport syndrome (ADAS).
  • The X-linked Alport syndrome (XLAS) is the most prevalent subtype of Alport syndrome with around 11K cases in 2023 in the US while autosomal dominant Alport syndrome (ADAS) is the least prevalent subtype of Alport syndrome.
  • To know more about Alport syndrome treatment guidelines, visit @ Alport Syndrome Management

Alport Syndrome Market to Witness Upsurge in Growth at a Massive CAGR of 69% by 2034 | DelveInsight

Retrieved on: 
Wednesday, April 17, 2024
USD, Urine, ACE, Finerenone, ESRD, Kidney, Otorhinolaryngology, Nephrotoxicity, Mutation, Hearing, Diagnosis, Glomerular filtration rate, Hearing loss, Blood, Swelling, Proteinuria, Kidney failure, Cochlea, Alport syndrome, Nephrology, EU4, GFR, ADAS, Heredity, Research, Genetic counseling, Kidney disease, Novartis, ARAS, Ophthalmology, COL4A4, Patient, Kidney transplantation, LAS, Dialysis, DSM-IV codes, COL4A3, Quality of life, Genetic disorder, Gene, Pharmaceutical industry

LAS VEGAS, April 17, 2024 /PRNewswire/ -- DelveInsight's Alport Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, Alport syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Key Points: 
  • Leading Alport syndrome companies such as Eloxx Pharmaceuticals, Chinook Therapeutics (A Novartis company), Bayer, Calliditas Therapeutics, Evotec, and others are developing novel Alport syndrome drugs that can be available in the Alport syndrome market in the coming years.
  • The disorder manifests in different forms such as autosomal recessive Alport syndrome (ARAS), X-linked Alport syndrome (XLAS), and autosomal dominant Alport syndrome (ADAS).
  • The X-linked Alport syndrome (XLAS) is the most prevalent subtype of Alport syndrome with around 11K cases in 2023 in the US while autosomal dominant Alport syndrome (ADAS) is the least prevalent subtype of Alport syndrome.
  • To know more about Alport syndrome treatment guidelines, visit @ Alport Syndrome Management

Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Operating and Financial Results

Retrieved on: 
Thursday, March 28, 2024
Research, JDRF, Kidney disease, Massachusetts General Hospital, Risk, Immunosuppression, Patient, Kidney transplantation, OLE, University, Tacrolimus, Glomerular filtration rate, Net, Investment, Society, Hospital, EGFR, Kidney, Safety, Pharmacokinetics, FACS, Annual general meeting, Pharmaceutical industry

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2023 operating and financial results and reviewed recent business highlights.

Key Points: 
  • In addition to our clinical development progress, tegoprubart was used for immunosuppression in historical kidney and heart pig-to-human xenotransplant procedures.
  • The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man with end-stage kidney disease.
  • Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting held in Philadelphia, PA in November 2023.
  • General and administrative expenses were $12.7 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022.

Daxor Corporation Acquires Volumex® and Megatope® From Its Existing Supplier Along With Glofil® to Enhance Existing Suite of Diagnostics

Retrieved on: 
Monday, March 25, 2024
GFR, Commercialization, BVA, Customer experience, Iodine (125I) human albumin, Glomerular filtration rate, Blood volume, Pharmaceutical industry

Oak Ridge, TN, March 25, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, announces today it has entered into a definitive agreement to acquire exclusive and worldwide rights and intellectual property to manufacture from its existing supplier for Volumex and Megatope from privately-held Iso-Tex Diagnostics, Inc. Daxor has also acquired the exclusive rights to Glofil, a drug that measures glomerular filtration rate (GFR), which Iso-Tex has been selling directly to its customer base.

Key Points: 
  • Daxor projects the acquisitions to be cash flow positive and accretive to earnings immediately upon transfer of the manufacturing.
  • This is due to the embedded revenue streams of the drugs and significantly higher margins that will be achieved with internalized production.
  • No payments will come due until manufacturing is fully transitioned to Daxor over the next 6-9 months.
  • The transaction is subject to customary conditions, including receipt of applicable regulatory approvals.

Alpine Immune Sciences Provides Corporate Update and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 18, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Research program, Administration, Congress, Development, WT, Lupus, Patient, Immunoglobulin A, Glomerular filtration rate, SLE, Inflammation, MD, UPCR, Neonatal Fc receptor, American College, Investment, Clinical trial, Society, EGFR, Nephrology, BAFF, Proteinuria, Immunoglobulin G, Autoimmunity, ALPN, Pharmaceutical industry

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported full year 2023 financial results and company highlights for the fourth quarter ended December 31, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported full year 2023 financial results and company highlights for the fourth quarter ended December 31, 2023.
  • “2023 was a transformational year for Alpine, with initial IgA nephropathy (IgAN) data presented at the American Society of Nephrology Kidney Week 2023 suggesting a best-in-class profile for povetacicept, our next-generation dual BAFF/APRIL inhibitor.
  • In addition, povetacicept was well tolerated during subcutaneous administration, with no instances of IgG
  • Net Loss: Net loss for the year ended December 31, 2023, was $32.2 million compared to $57.8 million for the same period in 2022.

CalciMedica Presents Data from Preclinical Studies of Auxora in Acute Kidney Injury at the 29th International AKI & CRRT Conference

Retrieved on: 
Wednesday, March 13, 2024
CRRT, Conference, Pneumonia, CRAC, Disease, Incidence, GFR, AKI, Patient, Physiology, COVID-19, Renal artery, Biomarker, Hemofiltration, T helper 17 cell, Mortality, Indiana University, Cell biology, Glomerular filtration rate, Respiratory failure, Doctor of Philosophy, Acute kidney injury, Ischemia, Kidney, Poster, Stage 2, Blood, Animal, Hospice and palliative medicine, Pharmaceutical industry

LA JOLLA, Calif., March 13, 2024 /PRNewswire/ -- CalciMedica Inc. (CalciMedica or the Company) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic diseases, last evening presented data from preclinical studies of Auxora™ in acute kidney injury (AKI) at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) in San Diego, CA. David Basile, Ph.D., Professor of Anatomy, Cell Biology and Physiology at Indiana University, gave an oral and poster presentation entitled "The Store-Operated Calcium Channel Inhibitor Auxora Improves Renal Function Following Ischemia-Induced Acute Kidney Injury in Rats."

Key Points: 
  • In rats with kidney injury akin to Stage 3 AKI, the rats treated with placebo died while those on Auxora survived and showed modest recovery of GFR.
  • We are excited as these studies support clinical observations of Auxora that suggest the drug may be beneficial for AKI patients."
  • The data presented at AKI & CRRT was from a series of studies referred to as Study 1 and Study 2.
  • These results indicate that Auxora has the ability to hasten the recovery of kidney function and improve survival in rat models of AKI.

Alnylam Reports Positive KARDIA-2 Topline Study Results Demonstrating Clinically Significant Blood Pressure Reductions When Zilebesiran is Added to Standard of Care Antihypertensives

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Therapy, Blood pressure, DBP, Amlodipine, Roche, Month, Safety, Glomerular filtration rate, ABPM, Trial of the century, Cardiology, Indapamide, AGT, Hypertension, American College, SBP, EGFR, Patient, Angiotensin, DB, Alnylam Pharmaceuticals, Medication, RNA interference, Pharmaceutical industry

Zilebesiran demonstrated an encouraging safety and tolerability profile when added to these standard of care antihypertensives.

Key Points: 
  • Zilebesiran demonstrated an encouraging safety and tolerability profile when added to these standard of care antihypertensives.
  • “We are thrilled that a single dose of zilebesiran achieved clinically significant, additional reductions in systolic blood pressure when administered to patients who are not adequately controlled with commonly prescribed antihypertensives,” said Simon Fox, Ph.D., Vice President, Zilebesiran Program Lead at Alnylam.
  • “These KARDIA-2 results, showing durable additional levels of blood pressure reduction on top of what is achieved by standard of care first-line antihypertensives with an encouraging safety profile, reinforce our confidence in zilebesiran’s differentiated profile.
  • The primary endpoint is the change from baseline in mean SBP at Month 3, assessed by 24-hour ABPM.

CalciMedica Announces FDA Clearance of IND Application for Phase 2 Trial of Auxora™ for the Treatment of Severe Acute Kidney Injury

Retrieved on: 
Tuesday, February 13, 2024
Oxygen, International, Chronic kidney disease, Incidence, FDA, Food, Dialysis, Glomerular filtration rate, Pneumonia, Hemofiltration, IRI, Risk, Conference, IMV, Angiopoietin, CRAC, Survivor, COVID-19, Classification, Death, Acute kidney injury, EGFR, AHRF, Patient, Biomarker, AKI, Survival, Disease, Kidney disease, Medicine, GFR, Endothelium, IND, Mortality, Pharmaceutical industry

LA JOLLA, Calif., Feb. 13, 2024 /PRNewswire/ -- CalciMedica, Inc. (CalciMedica or the Company) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic diseases, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for the Company's lead product candidate, Auxora™, a potent and selective small molecule inhibitor of Orai1-containing CRAC channels, to be evaluated in a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024 and data expected in 2025.

Key Points: 
  • CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024 and data expected in 2025.
  • "Through KOURAGE, we aim to determine how Auxora can benefit patients with severe AKI and potentially reduce the high mortality rate associated with this disease."
  • AKI is classified as stages 1, 2 and 3 depending on the degree of kidney injury.
  • A single dose of Auxora after IRI increased GFR by 61% and decreased mononuclear (inflammatory) cell infiltration by 30%.