UPCR

Aurinia Presents Breadth of Data at ASN 2023 Demonstrating Clinical Importance of LUPKYNISⓇ for Managing Lupus Nephritis

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星期四, 十一月 2, 2023
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Patient, Lupus nephritis, National Institutes of Health, CNI, EGFR, Kidney failure, AURORA, Safety, Lupus, Kidney, ALMS, Society, Acute kidney injury, Clinical trial, ASN, MMF, NIH, Histology, Glucocorticoid, UPCR, Conditional sentence, Bangladesh Technical Education Board, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Ohio State University Wexner Medical Center, Proteinuria, Toxic leukoencephalopathy, Pharmaceutical industry, Black, Aurinia, LN

Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.

Key Points: 
  • Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.
  • Activity scores for both arms improved to a similar degree, while the chronicity scores remained stable in both arms.
  • “The results presented at ASN this week demonstrate important clinical and mechanistic findings associated with LUPKYNISⓇ treatment.
  • Following is the complete guide to Aurinia’s presentations at ASN 2023:
    Title: Comparison of dual-immunosuppressive therapy and a voclosporin-based, triple-immunosuppressive regimen for lupus nephritis: a propensity analysis of ALMS and AURORA 1 studies

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

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星期四, 十一月 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.

Equillium Announces Abstracts Accepted for Presentation at the 2023 Annual Meetings of the American Society of Nephrology and the American College of Rheumatology

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星期四, 十月 19, 2023
Oncology, Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, American College, EGFR, Therapy, Organic acid, Society, American Society of Nephrology, San Diego Convention Center, ASN, Abstract, American College of Rheumatology, Trial of the century, UPCR, Pennsylvania Convention Center, Patient, ACR, Serum albumin, Pharmaceutical industry, Itolizumab

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that abstracts were accepted for poster presentations at the annual meetings of the American Society of Nephrology (ASN) and the American College of Rheumatology (ACR).

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 that abstracts were accepted for poster presentations at the annual meetings of the American Society of Nephrology (ASN) and the American College of Rheumatology (ACR).
  • The abstracts highlight data from 17 Type B subjects in the Phase 1B EQUALISE study in highly proteinuric lupus nephritis patients (mean 24-hour urine protein creatinine ratio (UPCR) > 4 g/day).
  • This is in the setting of tapering the corticosteroids, stable kidney function (eGFR) and increasing serum albumin while on study.
  • Itolizumab was well tolerated when treated every 2 weeks for 24 weeks; with only 2 subjects reporting serious adverse events.

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

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星期四, 十月 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.

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

Retrieved on: 
星期四, 十月 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.

Eloxx Pharmaceuticals Reports Additional Confirmation that All Nonsense Mutation Alport Syndrome Patients Treated with ELX-02 in Phase 2 Study had Improvement in Kidney Morphology and Clinical Benefit of Reduction or Stabilization of Proteinuria

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星期一, 十月 9, 2023
Health, Transmission electron microscopy, RNA, Urine protein/creatinine ratio, Kidney, Proteinuria, Rare, Biopsy, FSD, UPCR, TEM, Patient, Medical imaging

WATERTOWN, Mass., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today reported results from an assessment of patient biopsies by NIPOKA GmbH (Nipoka). They have developed a highly accurate method for the quantification of podocyte foot process morphology. These results confirm previously reported positive biopsy results from the proof-of-concept Phase 2 open-label clinical trial (NCT05448755) of ELX-02 for the treatment of Nonsense Mutation Alport syndrome patients. Analysis of formalin-fixed paraffin-embedded (FFPE) biopsy samples by Nipoka show ELX-02 treatment improved podocyte foot process morphology with lower effacement in all three patients at the end of the 8-week study period.

Key Points: 
  • They have developed a highly accurate method for the quantification of podocyte foot process morphology.
  • These results confirm previously reported positive biopsy results from the proof-of-concept Phase 2 open-label clinical trial ( NCT05448755 ) of ELX-02 for the treatment of Nonsense Mutation Alport syndrome patients.
  • “With this accurate analysis of the patient biopsies and quantification of changes, we now have unequivocal evidence of morphology and clinical improvement in all three Nonsense Mutation Alport patients treated with ELX-02.
  • Improvement in kidney morphology drives clinical benefit in this devastating rare disease,” said Sumit Aggarwal, President and Chief Executive Officer of Eloxx.

Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

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星期二, 十月 3, 2023
EEA, CET, Health care, EGFR, Medication, Glomerular filtration rate, Immunoglobulin A, Budesonide, Person, Proteinuria, Sustainability, European Economic Area, CALT, Risk, Kidney, United Kingdom, Stada Arzneimittel, Lancet, UPCR, MHRA, Disease, Pharmaceutical industry, IgA nephropathy

STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.

Key Points: 
  • STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.
  • Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need.
  • Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
  • : +46 76 403 35 43, email: [email protected]
    The information was sent for publication, through the agency of the contact persons set out above, on October 3, 2023 at 09:20 a.m. CET.

Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

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星期二, 十月 3, 2023
EEA, CET, Health care, EGFR, Medication, Glomerular filtration rate, Immunoglobulin A, Budesonide, Person, Proteinuria, Sustainability, European Economic Area, CALT, Risk, Kidney, United Kingdom, Stada Arzneimittel, Lancet, UPCR, MHRA, Disease, Pharmaceutical industry, IgA nephropathy

STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.

Key Points: 
  • STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.
  • Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need.
  • Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
  • : +46 76 403 35 43, email: [email protected]
    The information was sent for publication, through the agency of the contact persons set out above, on October 3, 2023 at 09:20 a.m. CET.

Eloxx Pharmaceuticals Reports Independent Confirmation of Positive Biopsy Results in All Patients Treated with ELX-02 in Phase 2 Clinical Study for Alport Syndrome

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星期一, 九月 18, 2023
Drug discovery, Food and Drug Administration, Breakthrough therapy, TEM, RNA, Alport syndrome, Patient, Proteinuria, Investigational New Drug, Rare, FDA, IND, Food, UPCR, Disease, Pharmaceutical industry, Medical imaging, Alport

WATERTOWN, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today reported additional independent confirmation on the positive TEM assessment results from its proof-of-concept Phase 2 open-label clinical trial (NCT05448755) of ELX-02 for the treatment of Alport syndrome after eight weeks of treatment. Visual assessment of TEM images from kidney biopsies showed an improvement in foot process effacement in all three treated patients consistent with disease regression. Alport syndrome is a rare genetic kidney disorder caused by mutations in COL4A3/4/5 genes, characterized by podocyte injury and impaired kidney filter function leading to proteinuria.

Key Points: 
  • Visual assessment of TEM images from kidney biopsies showed an improvement in foot process effacement in all three treated patients consistent with disease regression.
  • Alport syndrome is a rare genetic kidney disorder caused by mutations in COL4A3/4/5 genes, characterized by podocyte injury and impaired kidney filter function leading to proteinuria.
  • Eloxx recently submitted an Investigational New Drug application (IND) to the FDA for ELX-02 for the treatment of Alport syndrome with nonsense mutations.
  • The IND, if allowed, would enable the inclusion of U.S.-based sites in the planned pivotal trial.

Eloxx Pharmaceuticals Provides Program Updates on ELX-02 and ZKN-013

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星期四, 九月 7, 2023
Drug discovery, Food and Drug Administration, Glomerular basement membrane, Ultrafiltration, RNA, Alport syndrome, Trial of the century, Proteinuria, Patient, Rare, FDA, IND, Podocyte, Food, UPCR, Biopsy, Disease, Pharmaceutical industry, Vaccine, Alport

WATERTOWN, Mass., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today provided an update on the continued advancement of ELX-02 for the treatment of Alport syndrome with nonsense mutations, including additional positive results from its Phase 2 clinical study evaluating ELX-02, as well as an update on ZKN-013.

Key Points: 
  • “We have shared the results of our Phase 2 study with several key opinion leaders and key stakeholders within the Alport syndrome community.
  • Based on the encouraging clinical results to date, Eloxx has submitted an IND application with the U.S. FDA for ELX-02 for the treatment of Alport syndrome with nonsense mutations.
  • Podocyte injury leads to the effacement (loss) of podocyte foot processes and proteinuria in nearly all cases of Alport syndrome.
  • Eloxx previously announced achievement of remission in one patient
    Eloxx is announcing today 3 month post treatment results.