Proteinuria

Travere Therapeutics to Present Abstracts on FILSPARI® (sparsentan) in IgA Nephropathy at World Congress of Nephrology and the American Nephrology Nurses Association

Retrieved on: 
Wednesday, April 3, 2024
ART, IgA nephropathy, Congress, Quality of life (healthcare), Patient, SAN, Kidney failure, Immunoglobulin A, RAAS, FSGS, PROTECT, Focal segmental glomerulosclerosis, Abstract, Kidney disease, Therapy, WCN, Proteinuria, ANNA, Communications satellite

SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present nine abstracts in rare kidney disease at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on April 13-16, 2024, and the American Nephrology Nurses Association (ANNA) National Symposium in Orlando, Florida, on April 14-17, 2024.

Key Points: 
  • SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present nine abstracts in rare kidney disease at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on April 13-16, 2024, and the American Nephrology Nurses Association (ANNA) National Symposium in Orlando, Florida, on April 14-17, 2024.
  • At WCN, the Company will present subgroup analyses of the Phase 3 PROTECT Study of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) showing the treatment effect across participants with different levels of baseline proteinuria.
  • At ANNA, the Company will present additional insights from the HONUS trial, including health-related quality of life (HRQoL) data and the humanistic burden experienced by patients with IgAN and focal segmental glomerulosclerosis (FSGS).
  • “The data we are presenting at WCN and ANNA reinforce the wealth of evidence supporting FILSPARI’s profile to become an effective foundational treatment replacing RAAS inhibition, with the potential to reduce the lifetime risk of kidney failure for patients with IgAN,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Vera Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, March 20, 2024
Quarter, Disease, Patient, UPCR, Clinical trial, Therapy, EGFR, Proteinuria, FDA, BLA, Hematuria, Pharmaceutical industry

“We believe atacicept 72-week data from the Phase 2b ORIGIN trial are consistent with a profile of true disease modification.

Key Points: 
  • “We believe atacicept 72-week data from the Phase 2b ORIGIN trial are consistent with a profile of true disease modification.
  • The ORIGIN 2b results also provide us with even greater confidence in the ongoing ORIGIN Phase 3 trial, which continues to be on track with regard to enrollment,” stated Robert Brenner, M.D., Chief Medical Officer of Vera Therapeutics.
  • During the year ended December 31, 2023, net cash used in operating activities was $92.2 million, compared to $67.6 million for the same period last year.
  • Vera reported $160.7 million in cash, cash equivalents, and marketable securities as of December 31, 2023.

Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis

Retrieved on: 
Monday, April 1, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, EOS, Itolizumab, Week, S1P, Dialysis, Type, AMP, Exercise, Ono Pharmaceutical, Infection, Lymphocytopenia, Patient, Serum albumin, Peripheral edema, CD6, Lupus, EULAR, EGFR, Therapy, Proteinuria, ALC, Lupus nephritis, Nursing

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.

Key Points: 
  • Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.
  • Key topline data from the Type B portion of the EQUALISE study in lupus nephritis:
    Subjects were highly proteinuric: baseline mean UPCR of 4.9 g/g.
  • Itolizumab treatment (over 6 months) was also associated with reductions in absolute lymphocyte counts (ALC), another known pharmacodynamic effect.
  • Two subjects had at least one serious adverse event, none of which were related to study treatment.

Vertex Advances Inaxaplin (VX-147) into Phase 3 Portion of Adaptive Phase 2/3 Clinical Trial for the Treatment of APOL1-Mediated Kidney Disease

Retrieved on: 
Monday, April 1, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, BTD, Orphan drug, APOL1, RPD, Disease, Patient, Apolipoprotein L1, FSGS, Standard of care, EMA, UPCR, European Medicines Agency, Vertex Pharmaceuticals, Clinical trial, Vertex, Proteinuria, Food, FDA, IDMC, VRTX, Pharmaceutical industry

The clinical trial is designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with proteinuric kidney disease mediated by two variants in the APOL1 gene, known as AMKD.

Key Points: 
  • The clinical trial is designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with proteinuric kidney disease mediated by two variants in the APOL1 gene, known as AMKD.
  • In addition, the trial has been expanded to include adolescents with AMKD ages 10 to 17 years.
  • The IDMC also recommended enrolling adolescents with AMKD ages 10 to 17 years in the Phase 3 portion of the study.
  • The European Medicines Agency (EMA) has also granted inaxaplin Priority Medicines (PRIME) and Orphan Drug designations for AMKD.

InnoCare Releases 2023 Results and Business Highlights

Retrieved on: 
Thursday, March 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, QD, Tafasitamab, Patient, B-cell lymphoma, NDA, SLE, POC, IND, Clinical trial, Bone marrow, IKZF1, Phase, Therapy, IGA, MCD, Dexamethasone, MCL, Neuromyelitis optica spectrum disorder, IKZF3, AML, NMOSD, Outline of health sciences, DLT, Cancer, Autoimmune disease, Safety, TYK2, HSA, NRDL, BLA, Follicular lymphoma, Food, GC, Development, Multiple sclerosis, PD, CRBN, Public, Gordon Ramsay's Bank Balance, Multiple myeloma, ITP, BCL2, Leukemia, Cmax, Gadolinium, HKEX, SRI, AAD, Proteinuria, DLBCL, Glucocorticoid, IVIG, Loss, European Hematology Association, American Academy, EHA, Lenalidomide, NHL, Non-Hodgkin lymphoma, CCR8, US FDA, BTK, NRS, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
  • In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs.
  • In June 2023, the ITP Phase II result was orally presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023.

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.

Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)

Retrieved on: 
Monday, March 11, 2024
Angiotensin, SAN, European Commission, EMA, Erosion (morphology), Committee, New Drug Application, PROTECT, FDA, Food, Dialysis, Shanda, Hope, Risk, Civil service commission, Therapy, CHMP, CSL Vifor, EGFR, Patient, Immunoglobulin A, Kidney disease, Disease, Kidney, CMA, Proteinuria, Pharmaceutical industry

The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.

Key Points: 
  • The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.
  • “Since being introduced under accelerated approval, FILSPARI has positively impacted the lives of many people living with IgAN.
  • “FILSPARI is at the forefront of emerging new treatment options providing hope for a delay in kidney transplant or dialysis.
  • The FDA has 60 days from the receipt of the application to determine whether to accept it for review.

Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy

Retrieved on: 
Friday, February 23, 2024
Head, SAN, European Commission, EMA, Marketing, Irbesartan, MAA, European, Food, CSL, Risk, Civil service commission, Therapy, CHMP, CSL Vifor, Patient, Immunoglobulin A, Kidney disease, Kidney, CMA, Proteinuria, Kidney failure, Pharmaceutical industry

SAN DIEGO, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ: TVTX) and CSL Vifor today announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). IgAN is a rare kidney disease and a leading cause of kidney failure. The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA for sparsentan. If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.

Key Points: 
  • The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA for sparsentan.
  • If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.
  • In August 2022, Travere Therapeutics and CSL Vifor announced they had submitted a Marketing Authorization Application (MAA) for CMA to the EMA.
  • In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand.