IgA nephropathy

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

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

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

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

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.

BioCryst R&D Day Highlights New Diversified Pipeline of First-in-Class/Best-in-Class Therapies with Five Programs Expected in Clinical Development in Next 24 Months

Retrieved on: 
Friday, November 3, 2023

A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .

Key Points: 
  • A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .
  • The team is excited to share our approach, and our expanded pipeline of new programs, at our R&D Day,” said Jon Stonehouse, president and chief executive officer of BioCryst.
  • The disease is caused by the deficiency of a natural inhibitor (SPINK5) of KLK5, a serine protease responsible for regulating skin shedding.
  • Netherton syndrome can be life threatening, especially during infancy when patients are vulnerable to dehydration and recurrent infections.

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

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.

New England Journal of Medicine Publishes Complete Results of Positive Phase 2 Trial of Sibeprenlimab in Treatment of Immunoglobulin A Nephropathy (IgAN)

Retrieved on: 
Thursday, November 2, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231102845310/en/
    The Phase 2 trial randomized 155 adult participants with biopsy-confirmed IgAN to monthly intravenous injections of sibeprenlimab 2, 4, or 8 mg/kg, or placebo for 12 months.
  • The primary outcome measure was the change from baseline in 24-hour urine protein-to-creatinine ratio (uPCR) at month 12.
  • The annual eGFR change was −2.7, +0.2, −1.5, and −7.4 ml/1.73 m2 with sibeprenlimab 2, 4, and 8 mg/kg, and placebo, respectively.
  • This reflects a stabilization of eGFR with sibeprenlimab compared to the eGFR decline observed with placebo.1
    The incidence of treatment-emergent adverse events (TEAEs) for patients on sibeprenlimab and placebo was similar.

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

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.

DaVita Unveils New Research to Drive Health Equity and Improve Care Quality during Annual American Society of Nephrology Meeting

Retrieved on: 
Thursday, November 2, 2023

DENVER and PHILADELPHIA, Nov. 2, 2023 /PRNewswire/ -- DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is presenting the findings of five new research projects at the American Society of Nephrology (ASN)'s annual "Kidney Week," which is currently underway in Philadelphia. The studies are focused on driving health equity and reducing hospitalizations, among other outcomes.

Key Points: 
  • DENVER and PHILADELPHIA, Nov. 2, 2023 /PRNewswire/ -- DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is presenting the findings of five new research projects at the American Society of Nephrology (ASN)'s annual "Kidney Week," which is currently underway in Philadelphia.
  • The studies are focused on driving health equity and reducing hospitalizations, among other outcomes.
  • To learn more about the CKD-RDN please click here , or stop by booth #1004 to meet with DCR representatives.
  • DaVita will share updates throughout the meeting on X (formerly Twitter) on @DaVitaDoc and @DaVitaResearch, and will join the online conversation using #KidneyWk.

New Drug Application Approval by the Pharmaceutical Administration Bureau of Macau for Nefecon® for the Treatment of Primary IgA Nephropathy

Retrieved on: 
Friday, October 27, 2023

The approval for Nefecon is for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

Key Points: 
  • The approval for Nefecon is for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.
  • Macau is the first region in Everest territories that received Nefecon approval.
  • The NDA for Nefecon in mainland China is under Priority Review and Nefecon was the first non-oncology medicine to receive Breakthrough Therapy Designation in China.
  • Nefecon has been available for clinical use in Shanghai Ruijin Hospital's Hainan subsidiary through an early-access program since April 2023.