B-cell activating factor

RemeGen's Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sjögren's Syndrome

Retrieved on: 
Wednesday, April 3, 2024
Rheumatoid arthritis, Autoimmunity, Lupus, Risk, Rheumatism, Patient, PSS, SLE, Diabetic nephropathy, Myasthenia gravis, IND, Mouth, Investigational New Drug, Cytokine, B-cell activating factor, Iga, FDA, FTD

The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs.

Key Points: 
  • The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs.
  • Telitacicept prevents abnormal differentiation and maturation of B-cells through a two-pronged approach, thereby treating various autoimmune diseases mediated by B-cells.
  • In December 2023, Telitacicept was granted Investigational New Drug (IND) by the FDA for the treatment of active pSS in adults.
  • Dr. Jianmin Fang, CEO of RemeGen, commented, "As the first fusion protein drug of its kind independently developed by RemeGen, we are delighted the FDA has recognized Telitacicept for fast track designation.

Aurinia Submits IND Application to US Food & Drug Administration for AUR 200

Retrieved on: 
Wednesday, December 20, 2023
Research, FDA, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Research and development, Food, Immunoglobulin A, Autoimmune disease, BAFF, IND, IgA nephropathy, APRIL, Lupus, Mouse, BCMA, Investigational New Drug, Membrane protein, B-cell activating factor, Rheumatology, American College, Safety, B cell, Pharmaceutical industry

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases.
  • AUR200 is a highly potent and specific Fc-fusion protein containing a modified B cell maturation antigen (BCMA), for enhanced binding to both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).
  • “Our IND submission for AUR200 is an important step forward for Aurinia’s pipeline and our mission to change the trajectory of autoimmune disease.
  • Aurinia acquired AUR200 as part of a strategy to diversify its development pipeline and leverage existing R&D capabilities to advance innovative therapeutic solutions to help people living with autoimmune diseases.

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 Announces Positive Week 36 Efficacy and Safety Results of Phase 2b ORIGIN Clinical Trial of Atacicept in IgAN in Late-Breaking Presentation at 60th European Renal Association (ERA) Congress

Retrieved on: 
Saturday, June 17, 2023
Enzyme inhibitor, ARB, B-cell activating factor, European Renal Association, Conference call, Clinical trial, EGFR, Immunoglobulin A, ERA, Proteinuria, Congress, IgA nephropathy, HIV disease progression rates, Patient, Therapy, ITT, Conference, Safety, Pharmaceutical industry

BRISBANE, Calif., June 17, 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 Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR through week 36. The week 36 results of ORIGIN were presented as a late-breaking presentation at the 60th European Renal Association (ERA) Congress, taking place June 15-18, 2023, in Milan, Italy and virtually.

Key Points: 
  • The week 36 results of ORIGIN were presented as a late-breaking presentation at the 60th European Renal Association (ERA) Congress, taking place June 15-18, 2023, in Milan, Italy and virtually.
  • Atacicept is the Company’s potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
  • “The week 36 results of the Phase 2b ORIGIN clinical trial build on a growing body of data that demonstrates atacicept's potential to modify and delay disease progression in IgAN.
  • Longer term results, including the ongoing eGFR data, from the Phase 2b ORIGIN clinical trial are planned for presentation later in 2023 and 2024.

Vera Therapeutics to Host Presentation of Week 36 Data from Phase 2b ORIGIN Clinical Trial of Atacicept in IgAN

Retrieved on: 
Thursday, June 15, 2023
ERA, Stanford University Medical Center, Congress, IgA nephropathy, Therapy, B-cell activating factor, Patient, European Renal Association, Immunoglobulin A, Pharmaceutical industry

The event will feature Richard Lafayette, M.D., F.A.C.P.

Key Points: 
  • The event will feature Richard Lafayette, M.D., F.A.C.P.
  • (Stanford University Medical Center), discussing week 36 data from the Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy (IgAN), which are initially being presented as a late-breaking clinical trial at the 60th European Renal Association (ERA) Congress on June 17, 2023.
  • Atacicept is a potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
  • A live question and answer session will follow the formal presentation.

Vera Therapeutics Initiates Pivotal Phase 3 (ORIGIN 3) Clinical Trial of Atacicept for the Treatment of IgA Nephropathy (IgAN)

Retrieved on: 
Wednesday, June 7, 2023
Enzyme inhibitor, ARB, B-cell activating factor, European Renal Association, Immunoglobulin A, ERA, Proteinuria, Congress, IgA nephropathy, HIV disease progression rates, Patient, Therapy, Safety, Pharmaceutical industry

BRISBANE, Calif., June 07, 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 initiation of the pivotal Phase 3 clinical trial (ORIGIN 3) of atacicept for the treatment of IgA nephropathy (IgAN). ORIGIN 3 is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of atacicept 150 mg in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite optimized angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB) therapy.

Key Points: 
  • BRISBANE, Calif., June 07, 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 initiation of the pivotal Phase 3 clinical trial (ORIGIN 3) of atacicept for the treatment of IgA nephropathy (IgAN).
  • Atacicept is a potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
  • “Our Phase 2 results have shown that atacicept targets the source of IgA nephropathy and improves kidney function as measured by statistically and clinically significant reductions in proteinuria.
  • As we enroll this pivotal Phase 3 trial, we plan to share longer term Phase 2 results later in 2023 and 2024.”

Vera Therapeutics Releases 36 Week Interim Analysis of Phase 2b Clinical Trial of Atacicept for the Treatment of IgA Nephropathy; Patients in the 150 mg Dose Group Achieved a Delta of 48% Versus Placebo in Mean Reduction in Proteinuria

Retrieved on: 
Monday, January 30, 2023
Infection, Safety, B-cell activating factor, Proteinuria, Nephrology, PP, BK, University of Leicester, Webcast, Viremia, ARB, FRCP, BLA, Patient, HIV disease progression rates, Clinical trial, FDA, ITT, Lupus nephritis, Immunoglobulin A, Week, AES, University, Therapy, Event, Pharmaceutical industry, IgA nephropathy

BRISBANE, Calif., Jan. 30, 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 disease, today announced results from a prespecified per-protocol (PP) analysis of the Phase 2b ORIGIN clinical trial of atacicept in patients with IgA nephropathy (IgAN) following announcement of topline results on January 3, 2023. The prior topline results reflected the intent-to-treat (ITT) analysis of all randomized patients (n=116), which is a conservative assessment of efficacy. In the prespecified PP analysis, the population was defined as patients who had completed treatment according to protocol (n=102). 14 patients across treatment arms who had protocol violations were identified by a blinded third-party CRO and excluded, for prespecified reasons as outlined in Figure 1.

Key Points: 
  • In the prespecified PP analysis, the population was defined as patients who had completed treatment according to protocol (n=102).
  • “This analysis, as well as certain subgroup analyses, will help to inform the design and management of the Phase 3 clinical trial.
  • In the PP analysis, at Week 24, the atacicept 150 mg dose group achieved a 41% mean reduction in proteinuria versus baseline and a 34% delta versus placebo (p=0.025).
  • With interim data at Week 36, the atacicept 150 mg dose group achieved a 47% mean reduction in proteinuria from baseline and a 48% delta versus placebo, as shown in Figure 2.

Vera Therapeutics Hosting a Key Opinion Leader Webinar on Atacicept for the Treatment IgA Nephropathy (IgAN)

Retrieved on: 
Wednesday, January 25, 2023
Society, Clinical trial, Safety, B-cell activating factor, International, Proteinuria, Radar, College, Surrogate, University of Leicester, ARB, FRCP, University, Patient, HIV disease progression rates, FDA, Kidney failure, Immunoglobulin A, KOL, BYU College of Life Sciences, Research, Doctor of Philosophy, Therapy, Pharmaceutical industry, IgA nephropathy

Atacicept is the Company’s potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).

Key Points: 
  • Atacicept is the Company’s potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
  • A live question and answer session will follow the formal presentation.
  • Dr. Barratt leads the Renal Research Group within the College of Life Sciences, University of Leicester.
  • His research is focused on a bench to bedside approach to improving our understanding of the pathogenesis of IgAN, a common global cause of kidney failure.

Vera Therapeutics Announces Positive Topline Results of Phase 2b ORIGIN Clinical Trial of Atacicept for the Treatment of IgA Nephropathy

Retrieved on: 
Tuesday, January 3, 2023
Immunoglobulin A, Clinical trial, Vera, B-cell activating factor, Chronic kidney disease, Infection, Autoimmune disease, Dialysis, Food, Therapy, ARB, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Event, HIV disease progression rates, EGFR, UPCR, AES, Disease, Week, Patient, University of Leicester, Proteinuria, FRCP, Safety, Kidney, University, Webcast, Nephrology, Glomerular filtration rate, Quality of life, Diagnosis, Surveying, Pharmaceutical industry, IgA nephropathy

BRISBANE, Calif., Jan. 03, 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 disease, today announced the Phase 2b ORIGIN clinical trial of atacicept in patients with immunoglobulin A nephropathy (IgAN) met its primary endpoint.

Key Points: 
  • Atacicept is the Company’s potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
  • These results build upon the prior integrated analysis of atacicept in randomized, double-blind, placebo-controlled clinical trials in over 1,500 patients to date – in which atacicept was well-tolerated.
  • “Atacicept could be a transformational treatment for patients with IgAN who currently have limited treatment options.
  • The full data sets from the ORIGIN clinical trial will be presented at a future medical meeting.