American Society of Nephrology

Equillium Reports Third Quarter 2023 Financial Results and Provides Corporate and Clinical Updates

Retrieved on: 
Mittwoch, November 8, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, American College, Lupus nephritis, Harvard Medical School, Education, Gastrointestinal tract, Itolizumab, MPH, Therapy, MPA, Dermatology, G&A, Organic acid, MAD, SAD, R, Society, American Society of Nephrology, ASN, Partnership, Abstract, American College of Rheumatology, UPCR, Investment, Patient, ACR, Alopecia areata, Pharmaceutical industry, MD, Nephrology

Equillium , Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the third quarter 2023 and provided corporate and clinical development updates.

Key Points: 
  • Equillium , Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the third quarter 2023 and provided corporate and clinical development updates.
  • “The third quarter was focused on clinical execution and expanding education on our multi-cytokine platform and clinical programs ahead of initial data expected later this year,” said Bruce Steel, chief executive officer at Equillium.
  • Cash, cash equivalents and short-term investments totaled $46.3 million as of September 30, 2023, compared to $48.4 million as of June 30, 2023.
  • Net cash used in operating activities in the third quarter of 2023 was $1.9 million.

Inozyme Pharma Reports Third Quarter 2023 Financial Results and Provides Business Highlights

Retrieved on: 
Dienstag, November 7, 2023
Generalized arterial calcification of infancy, Patient, Research, Research and development, Genomics, Clinical trial, PD, Calciphylaxis, Therapy, Biomarker, ESKD, G&A, American Society of Nephrology, Conference, Pros, Kidney disease, R, American Society for Bone and Mineral Research, Society, PXE, Columbia University School of General Studies, ENPP1, ASN, PK, Clinical Global Impression, Annual general meeting, GIC, Safety, ABCC6, Investment, Doctor of Philosophy, Administration, Nursing, Pharmaceutical industry

BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“Inozyme” or the “Company”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today reported financial results for the third quarter ended September 30, 2023 and provided business highlights.

Key Points: 
  • Patient recruitment is underway, and the Company remains on track to report topline data in mid-2025.
  • Exploratory efficacy data reported suggested clinical benefit for ENPP1 Deficiency, including improvement in key biomarkers, patient-reported outcomes (PROs), and functional outcomes.
  • R&D Expenses were $13.3 million for the quarter ended September 30, 2023, compared to $12.2 million for the prior-year period.
  • Net loss was $16.6 million, or $0.29 loss per share, for the quarter ended September 30, 2023, compared to $16.4 million, or $0.38 loss per share, for the prior-year period.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Dienstag, 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: 
Dienstag, 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.

FibroGen Reports Third Quarter 2023 Financial Results

Retrieved on: 
Montag, November 6, 2023
Sale, JDE, AstraZeneca, LAPC, Pancreatic Cancer Action Network, American Society of Nephrology, CD46, Poster, Society, Bank statement, Chronic kidney disease, Immunotherapy, Growth, ADC, Interest, ASN, Webcast, Abstract, Pamrevlumab, Pancreatic cancer, Oncology, Anemia, CKD, European Society of Gynaecological Oncology, Investment, Patient, CIA, SAN, Shanda, Pharmaceutical industry, Video game, Vaccine, Roxadustat

Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.

Key Points: 
  • Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.
  • Restructuring charge for the third quarter of 2023 was $12.6 million, or $0.13 impact to net loss per basic and diluted share, resulting from the reduction in U.S. workforce announced in July 2023.
  • The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.
  • FibroGen will host a conference call and webcast today, Monday, November 6, 2023, at 5:00 PM Eastern Time to discuss financial results and provide a business update.

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: 
Samstag, 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: 
Freitag, 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.

Ardelyx Shares Positive Data from Studies of XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor, at ASN Kidney Week 2023

Retrieved on: 
Freitag, November 3, 2023
Spotlight, Education, Incidence, Food, Diarrhea, Sevelamer, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, American Society of Nephrology, SAE, Chronic kidney disease, Quality of life, Dialysis, ASN, Kidney disease, Peritoneal dialysis, CKD, Safety, Kidney, Hospital, Pennsylvania Convention Center, Cohort, Memory, Pharmaceutical industry, Phosphorus, Patient, MD, Hyperphosphatemia, Nephrology

Ardelyx’s presence at Kidney Week 2023 will honor the memory of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and a passionate advocate for patients with kidney disease.

Key Points: 
  • Ardelyx’s presence at Kidney Week 2023 will honor the memory of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and a passionate advocate for patients with kidney disease.
  • XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.
  • Additionally, Ardelyx is hosting an XPHOZAH Exhibitor Spotlight at ASN Kidney Week 2003.
  • Director of Home and Peritoneal Dialysis Programs, Boise Kidney & Hypertension Institute, and by David Spiegel, MD, Vice President of Nephrology at Ardelyx.

New Phase 3 data with aprocitentan for patients with resistant hypertension has been presented at the American Society of Nephrology Kidney Week 2023

Retrieved on: 
Freitag, November 3, 2023
Patient, Science, Blood pressure, American Heart Association, MD, Glomerular filtration rate, Society, American Society of Nephrology, LTD, Chronic kidney disease, ASN, Hypertension, IDIA, CKD, Safety, AHA, Lancet, Proteinuria, Pharmaceutical industry, Idorsia

Patients with hypertension can often successfully control their blood pressure by combining a healthier lifestyle with effective medication.

Key Points: 
  • Patients with hypertension can often successfully control their blood pressure by combining a healthier lifestyle with effective medication.
  • However, approximately 10% of patients have resistant hypertension where the blood pressure remains high despite receiving at least three antihypertensive medications of different pharmacological classes, including a diuretic, at optimal doses.
  • Detailed results were published in The Lancet and presented as a Late-Breaking Science presentation during the American Heart Association (AHA) Scientific Sessions in November 2022.
  • More details and commentary can be found in the dedicated press release and an investor webcast featuring Prof. Markus Schlaich, an investigator in PRECISION.

XORTX Sponsored Study Presented at the American Society of Nephrology – Kidney Week 2023

Retrieved on: 
Donnerstag, November 2, 2023
Uric acid, Session, University of Colorado Colorado Springs, ADPKD, Xanthine oxidase, Polycystic kidney disease, Effect, Cytokine, Research, Society, American Society of Nephrology, Acute kidney injury, PKD, ASN, Hyperuricemia, Kidney disease, University, Diet, Nephrology, Therapy, Patient, Oxipurinol, Pharmaceutical industry, Phosphorus, Prognosis

CALGARY, Alberta, Nov. 02, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the presentation of new research findings at the American Society of Nephrology meeting being held November 3, 2023 in Philadelphia. The abstract entitled "The Effect of Lowering Uric Acid with a Xanthine Oxidase Inhibitor on PKD in Mice” was reviewed by the ASN review panel for scientific merit and novel discoveries. The studies were conducted at the University of Colorado in the independent laboratory of Dr. Charles Edelstein and were sponsored by XORTX. The studies will be presented at Kidney Week during the Session Title: Genetic Diseases: Cystic - Therapeutic Investigations and Prognosis, November 2, 2023.

Key Points: 
  • The studies were conducted at the University of Colorado in the independent laboratory of Dr. Charles Edelstein and were sponsored by XORTX.
  • The studies will be presented at Kidney Week during the Session Title: Genetic Diseases: Cystic - Therapeutic Investigations and Prognosis, November 2, 2023.
  • This poster reports amalgamated results of studies in either rat and mouse models of polycystic kidney disease (“PKD”) challenged with low to moderate circulating uric acid.
  • The effect of increased uric acid on cyst growth – kidney size - and kidney function, as well as inflammatory markers was measured.