Immunoglobulin A

EQS-News: Biotest’s Trimodulin shows reduced mortality in patients with severe community-acquired pneumonia through rapid normalisation of inflammation

Retrieved on: 
Thursday, December 14, 2023
University College London, Community-acquired pneumonia, Ventilation, Intensive care medicine, Immunoglobulin A, Mortality, Inflammation, Multiple organ dysfunction syndrome, Plasma, Septic shock, COVID-19, CAP, Antibody, Patient, Oxygen, Sepsis, SCAP, Immunoglobulin M, Immunoglobulin G, Immune system, Failure, Pneumonia, Vaccine, Pharmaceutical industry

The article describes new mechanisms by which trimodulin supports the immune system in patients with severe Community-Acquired Pneumonia (sCAP).

Key Points: 
  • The article describes new mechanisms by which trimodulin supports the immune system in patients with severe Community-Acquired Pneumonia (sCAP).
  • One major characteristic of sCAP patients is that their immune system becomes dysregulated, which results in inflammation.
  • The results reported, support the currently ongoing investigation of trimodulin in artificial ventilated patients with sCAP with evidence of significant inflammation (ESsCAPE trial).
  • In addition, trimodulin is currently also in development for the treatment of hospitalized, oxygen-supported patients with non-severe CAP, including COVID-19 (TRICOVID trial).

Vera Therapeutics Provides Business Update and Reports Third Quarter Financial Results

Retrieved on: 
Thursday, November 9, 2023
APRIL, Hematuria, EGFR, Quarter, Society, American Society of Nephrology, BAFF, Disease, Risk, Serum, Kidney disease, Kidney, Vera, Therapy, Patient, Death, Immunoglobulin A, Proteinuria, Pharmaceutical industry, Cryptocurrency, IgA nephropathy

“Vera presented additional positive data from the Phase 2b ORIGIN trial at Kidney Week 2023, which support the potential of atacicept as a disease-modifying treatment for patients with IgAN.

Key Points: 
  • “Vera presented additional positive data from the Phase 2b ORIGIN trial at Kidney Week 2023, which support the potential of atacicept as a disease-modifying treatment for patients with IgAN.
  • We showed that patients on atacicept achieved durable and significant Gd-IgA1 reduction over 36 weeks regardless of baseline quartile.
  • High serum levels of galactose-deficient IgA1 (Gd-IgA1) are associated with greater risk of end-stage renal disease or death.
  • Vera reported $159.9 million in cash, cash equivalents, and marketable securities as of September 30, 2023.

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.

Vera Therapeutics Presents Positive Data from Phase 2b ORIGIN Study Showing Resolution of Hematuria in Majority of Patients at the American Society of Nephrology Kidney Week 2023

Retrieved on: 
Saturday, November 4, 2023
Patient, APRIL, Hematuria, EGFR, Tetanus, Diphtheria, Immunoglobulin A, Poster, Society, American Society of Nephrology, BAFF, Disease, COVID-19, Risk, Immunity, ASN, Kidney disease, Safety, Overalls, UPCR, Therapy, Kidney, Death, Infection, Proteinuria, Mineral wool, Pharmaceutical industry, Vaccine, IgA nephropathy

BRISBANE, Calif., Nov. 04, 2023 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced the presentation of three posters – including an additional analysis of week 36 data from the Phase 2b ORIGIN study demonstrating resolution of hematuria in the majority of patients – on the Company’s product candidate atacicept in patients with immunoglobulin A nephropathy (IgAN) at the American Society of Nephrology (ASN) Kidney Week 2023, in Philadelphia, PA.

Key Points: 
  • Analysis of week 36 data from Phase 2b ORIGIN study shows atacicept 150 mg substantially reduces serum Gd-IgA1 and resolves hematuria in the majority of patients.
  • Additional poster presentations provide further safety analysis of Phase 2b and details of pivotal Phase 3 clinical trial design, which is currently enrolling.
  • At week 36 of the ORIGIN Phase 2b study of atacicept in patients with IgAN, hematuria resolved in 80% of patients (n=12/15) receiving atacicept 150 mg compared to 5% (n=1/19) in the placebo group.
  • Through the randomized, placebo-controlled period, infections were balanced between atacicept and placebo in both the Phase 2a JANUS and Phase 2b ORIGIN studies.

Travere Therapeutics Announces Late-Breaking Data from Phase 3 Studies of Sparsentan in IgAN and FSGS Published in The Lancet and The NEJM Respectively and Presented at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Friday, November 3, 2023
University of Minnesota Medical School, EGFR, Key finding attacks, Heart Protection Study, Kidney failure, Kidney, University Center, SGLT2, Kidney disease, Society, American Society of Nephrology, Quality of life, Disease, Division, Clinical trial, ASN, Jay Traver, Abstract, The New England Journal of Medicine, Overload, University, Immunoglobulin A, Focal segmental glomerulosclerosis, Therapy, Patient, Death, International Pediatric Nephrology Association, SAN, Proteinuria, Pharmaceutical industry, Dietary supplement, Medical device, IgA nephropathy, Irbesartan, PROTECT, Nephrology, FSGS, Lancet

SAN DIEGO, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced additional data from two pivotal clinical studies demonstrating sparsentan has the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT) and The New England Journal of Medicine (DUPLEX).

Key Points: 
  • Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT ) and The New England Journal of Medicine (DUPLEX) .
  • The absolute overall change in kidney function from baseline to the end of the study for patients treated with FILSPARI was -5.8 mL/min/1.73m2 compared to -9.5 mL/min/1.73m2 with irbesartan.
  • Treatment with FILSPARI demonstrated lower rates of the composite endpoint of 40% decline in eGFR, kidney failure or death compared to irbesartan.
  • Sparsentan showed a consistent and sustained achievement of complete remission of proteinuria in 18.5% of patients on sparsentan vs. 7.5% for irbesartan.

Alpine Immune Sciences Presents New Preclinical Data on Povetacicept in Myasthenia Gravis at the American Association of Neuromuscular & Electrodiagnostic Medicine 2023 Annual Meeting

Retrieved on: 
Friday, November 3, 2023
Research, Neurology, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, AANEM, Myasthenia gravis, Neonatal Fc receptor, ALPN, IgA nephropathy, Therapy, Treatment, MG, MD, Inflammation, Volunteering, Date-time group, Alpine, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, Autoimmunity, Glomerulonephritis, Pharmaceutical industry, Vaccine

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the Company presented new preclinical data on povetacicept in myasthenia gravis at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting (AANEM), November 1-3, 2023 in Phoenix, Arizona.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the Company presented new preclinical data on povetacicept in myasthenia gravis at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting (AANEM), November 1-3, 2023 in Phoenix, Arizona.
  • In addition, the Company presented safety, tolerability, pharmacokinetic, and pharmacodynamic data from RUBY-1, a phase 1 study of povetacicept in healthy adult volunteers.
  • In a model of murine experimental autoimmune myasthenia gravis (EAMG), povetacicept improved disease activity, with clinical scores superior to treatment with either the FcRn inhibitor efgartigimod or an anti-CD20 depleting antibody.
  • “These data indicate that povetacicept might deliver efficacy superior to some therapeutics currently in clinical use for myasthenia gravis and other autoantibody-related neurological diseases.

Alpine Immune Sciences Presents Initial Clinical Data on Povetacicept in Autoimmune Glomerulonephritis in a Late-Breaking Poster Session at the American Society of Nephrology Kidney Week 2023

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, University of Leicester, Survival, FRCP, ALPN, GN, EGFR, Biomarker, Fig, Nephrology, PMN, MD, Inflammation, Cytokine, Doctor of Philosophy, Glomerular filtration rate, Immunoglobulin A, American Society of Nephrology, Multimedia, Society, BAFF, Glossary of education terms (G–L), Disease, Barratt, ASN, Webcast, Emory University School of Medicine, University, Immunoglobulin G, Autoimmunity, Glomerulonephritis, Patient, Infection, Vaccine, Sewage treatment, Pharmaceutical industry, Research, IgA nephropathy, Proteinuria, Alpine, Medicine, UPCR

RUBY-3 is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, where povetacicept is administered subcutaneously (SC) once every four weeks for up to 48 weeks.

Key Points: 
  • RUBY-3 is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, where povetacicept is administered subcutaneously (SC) once every four weeks for up to 48 weeks.
  • A higher dose of povetacicept, 240 mg SC every four weeks, continues to enroll, with initial data expected in 1H 2024.
  • A higher dose of povetacicept 240 mg every four weeks is currently being explored and will be of great interest.
  • “We eagerly await the initial data from the next 240 mg dose level in the first half of 2024.

BioCryst Begins Enrollment in Proof-of-Concept Trial to Confirm Safe, Effective, Once-daily Dose of Oral Factor D Inhibitor, BCX10013

Retrieved on: 
Thursday, October 26, 2023
BioCryst Pharmaceuticals, IgA nephropathy, Physical examination, Incidence, PNH, Biomarker, NCT, RESEARCH, Paroxysmal nocturnal hemoglobinuria, Pharmacokinetics, ClinicalTrials.gov, Clinical trial, Immunoglobulin A, Safety, Vital signs, PARK, Patient, LDH, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., Oct. 26, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the enrollment of the first patient in a proof-of-concept clinical trial evaluating BCX10013, a potential once-daily, oral Factor D inhibitor for the treatment of complement-mediated diseases.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Oct. 26, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the enrollment of the first patient in a proof-of-concept clinical trial evaluating BCX10013, a potential once-daily, oral Factor D inhibitor for the treatment of complement-mediated diseases.
  • The goal of this proof-of-concept trial is to understand the preliminary efficacy and safety profile of once-daily dosing with BCX10013.
  • The trial design employs intra-subject dose escalation approximately every four weeks with the option to continue treatment for up to 24 weeks.
  • For more information about the trial, visit ClinicalTrials.gov and search NCT number NCT06100900.

Calliditas Therapeutics to Present Seven Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Thursday, October 19, 2023
Kidney, Pregnancy, Adrenal insufficiency, Biomarker, EGFR, Vaccine, Glaucoma, Budesonide, American Society of Nephrology, Diabetes, Infection, Ritonavir, CYP3A4, Ciclosporin, Disease, Risk, Capsule, Itraconazole, UPCR, Parasitism, Hypersensitivity, Proteinuria, Alport syndrome, Saquinavir, Measles, Prediabetes, Miscarriage, Immune system, HPA, Ketoconazole, Fetus, CALT, Patient, Anaphylaxis, Tropical ulcer, IgA nephropathy, Indinavir, BAFF, Contraindication, Serum, Cataract, Birth, Administration, Society, Liver, Erythromycin, ASN, Hypertension, Osteoporosis, Immunoglobulin A, Drug interaction, Immunosuppression, Pharmaceutical industry, Dietary supplement, Alport

STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.

Key Points: 
  • STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.
  • Poster presentation details are below and will be available on the Presentation and Publication page on the Calliditas' corporate website following the meeting.
  • It has not been established whether TARPEYO slows kidney function decline in patients with IgAN.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.