IgA nephropathy

Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

Retrieved on: 
Tuesday, October 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.

Ionis enters agreement with Roche for two novel RNA-targeted programs for Alzheimer's disease and Huntington's disease

Retrieved on: 
Wednesday, September 27, 2023
Huntington's disease, HD, Learning, Partnership, Therapy, Ionis Pharmaceuticals, HTT, Systemic disease, Geographic atrophy, IONS, GA, Immunoglobulin A, RNA, Sympathetic nervous system, Huntingtin, Science, Neuroscience, IgA nephropathy, Patient, Knowledge, AD, Neurology, Alzheimer's disease, Fine chemical, Pharmaceutical industry, Ionis

"We are excited to expand our partnership with Roche, a global leader in developing and delivering innovative treatments to patients," said Brett P. Monia, Ph.D., Ionis' chief executive officer.

Key Points: 
  • "We are excited to expand our partnership with Roche, a global leader in developing and delivering innovative treatments to patients," said Brett P. Monia, Ph.D., Ionis' chief executive officer.
  • "With this new collaboration, we are joining forces to accelerate the discovery and development of novel therapies for people living with Alzheimer's disease and Huntington's disease globally.
  • Collaborating on these two programs enables Ionis to advance our wholly owned programs, including those in neurology, aligned with our strategic priorities."
  • IONIS-FB-LRx is currently in a Phase 2 study for GA, led by Ionis, and a Phase 3 study for IgAN led by Roche.

Travere Therapeutics to Present Abstracts at the 17th International Symposium on IgA Nephropathy (IIGANN 2023)

Retrieved on: 
Tuesday, September 26, 2023
Kidney failure, Jay Traver, SPARTAN, IgA nephropathy, Immunoglobulin A, Proteinuria, International Symposium on Endovascular Therapy, Patient, SAN, Radar, Therapy, Safety, Pharmaceutical industry

SAN DIEGO, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present preliminary findings from the SPARTAN Study evaluating the potential effect of FILSPARI® (sparsentan) as a first-line therapy in patients with newly diagnosed IgA nephropathy (IgAN) in a late-breaking trial session at the 17th International Symposium on IgA Nephropathy (IIGANN2023) in Ryogoku, Tokyo, September 28-30, 2023.

Key Points: 
  • SAN DIEGO, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present preliminary findings from the SPARTAN Study evaluating the potential effect of FILSPARI® (sparsentan) as a first-line therapy in patients with newly diagnosed IgA nephropathy (IgAN) in a late-breaking trial session at the 17th International Symposium on IgA Nephropathy (IIGANN2023) in Ryogoku, Tokyo, September 28-30, 2023.
  • The Company will also present preclinical data supporting the nephroprotective mechanism of action of sparsentan, a dual endothelin angiotensin receptor antagonist, and an analysis of the UK National Registry of Rare Renal Diseases (RaDaR) which demonstrated that patients with IgAN traditionally considered ‘low-risk’, with proteinuria less than one gram per day, had high rates of kidney failure.
  • “Patients with IgA nephropathy need both early and effective treatment options capable of significant and sustained reduction of proteinuria to preserve kidney function,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.
  • “We’re pleased to be presenting 24-week data on proteinuria reduction, blood pressure control, and safety from the ongoing SPARTAN Study evaluating the effect of sparsentan as a first-line treatment option in patients with newly diagnosed IgAN.”
    Sparsentan Treatment of Incident Patients With IgA Nephropathy as First-line Therapy: Interim Findings From the SPARTAN Trial

Spherix Introduces Patient Chart Dynamix™, an Enhanced Independent Pharmaceutical Market Research Chart Audit

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Tuesday, September 26, 2023
Trigger, NASA RealWorld-InWorld Engineering Design Challenge, Drug development, Complement, Psoriasis, FSGS, Atopic dermatitis, IgA nephropathy, Research, Diabetic retinopathy, Attention, HCP, Psoriatic arthritis, Patient, Physician, Nephritis, Rheumatoid arthritis, Diagnosis, Inflammatory bowel disease, Chronic kidney disease, Driver, Dialysis, Lupus nephritis, Pharmaceutical industry, Nursing, Medical device, Risk management, Alopecia areata

Exton, PA, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Spherix Global Insights, a trusted leader in pharmaceutical market research, is delighted to announce the launch of its latest product, Patient Chart Dynamix™.

Key Points: 
  • Exton, PA, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Spherix Global Insights, a trusted leader in pharmaceutical market research, is delighted to announce the launch of its latest product, Patient Chart Dynamix™.
  • Patient Chart Dynamix utilizes a trusted and thorough approach to gather and analyze data from prescriber-provided electronic medical records and patient charts.
  • Discover Hidden Patient Insights: Patient Chart Dynamix™ uncovers valuable insights relevant to unique patients that traditional diagnosis codes can't capture.
  • Patient Chart Dynamix™ is a testament to Spherix's commitment to innovation and excellence in pharmaceutical market research.

American Kidney Fund Launches Educational Awareness Campaigns for Two Rare Kidney Diseases

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Tuesday, September 26, 2023
Infection, Tissue, Kidney failure, AKF, Inflammation, Immunoglobulin A, Kidney, Antibody, Hyperkinesia, C3, New Brunswick neurological syndrome of unknown cause, Novartis, Patient, American Kidney Fund, Blood, Immune system, Glomerulopathy, Diagnosis, Health, Kidney disease, Disease, Pharmaceutical industry, IgA nephropathy

ROCKVILLE, Md., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) launched educational awareness campaigns for two rare kidney diseases: complement 3 glomerulopathy (C3G) and IgA nephropathy (IgAN).

Key Points: 
  • ROCKVILLE, Md., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) launched educational awareness campaigns for two rare kidney diseases: complement 3 glomerulopathy (C3G) and IgA nephropathy (IgAN).
  • The campaigns, sponsored by Novartis, provide patients with information about the diseases and connect them with resources to help them better understand and manage these conditions.
  • C3G and IgAN are two types of kidney diseases that are related to improper function of the immune system, which is your body's cells and tissues that fight infection.
  • The C3G and IgAN campaigns are part of AKF’s ongoing work to increase awareness and understanding of rare kidney diseases and ensure people with these conditions have access to critical resources.

Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control, Irbesartan

Retrieved on: 
Thursday, September 21, 2023
Medicine, Kidney failure, International, Heart Protection Study, CMA, Jay Traver, European Medicines Agency, Clinical trial, EGFR, European Directive on Traditional Herbal Medicinal Products, CSL Vifor, Immunoglobulin A, Dialysis, Committee, EMA, Proteinuria, Conditional, Nephrology, ANCOVA, Shanda, Publication, Patient, Division, Risk, Irbesartan, Kidney transplantation, Webcast, Committee for Medicinal Products for Human Use, FDA, Therapy, PROTECT, Kidney disease, Safety, CHMP, Hydraulic machinery, Medical device, Pharmaceutical industry, EU, IgA nephropathy

This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.

Key Points: 
  • This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.
  • “Since our accelerated approval, we’ve continued to hear inspiring stories of the impact this medicine is having on people living with IgAN.
  • While eGFR total slope narrowly missed statistical significance, the overall evidence from PROTECT suggests potential long-term benefit of FILSPARI as a foundational treatment for patients with IgAN.
  • Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.

Ligand’s Partner Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control

Retrieved on: 
Thursday, September 21, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Kidney failure, Heart Protection Study, CMA, Jay Traver, European Medicines Agency, EGFR, European Directive on Traditional Herbal Medicinal Products, CSL Vifor, Medicine, Committee, EMA, Proteinuria, Conditional, Shanda, ANCOVA, Publication, Patient, Risk, Irbesartan, Committee for Medicinal Products for Human Use, FDA, Therapy, PROTECT, Kidney disease, Safety, CHMP, Hydraulic machinery, Pharmaceutical industry, EU, IgA nephropathy

This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.

Key Points: 
  • This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.
  • We’re proud of the high bar we’ve set in delivering the only head-to-head study in IgAN, which compares FILSPARI against maximally tolerated dose of irbesartan.
  • Since our accelerated approval, we’ve continued to hear inspiring stories of the impact this medicine is having on people living with IgAN.
  • While eGFR total slope narrowly missed statistical significance, the overall evidence from PROTECT suggest potential long-term benefit of FILSPARI as a foundational treatment for patients with IgAN.

Everest Medicines Enters into Collaboration and License Agreement with Kezar Life Sciences to Develop and Commercialize Zetomipzomib in Greater China and other Asian Markets

Retrieved on: 
Thursday, September 21, 2023
Vaccine, Partnership, Prevalence, NDA, SLE, Inflammation, BTK, Kidney, Ulcerative colitis, HKEX, Patient, Risk, Internal medicine, IgA nephropathy, Lupus nephritis, National Medical Products Administration, Mortality, Immunosuppression, IND, Safety, Pharmaceutical industry, Mount Everest, LN, Kezar Stadium

"Lupus Nephritis is the most common secondary immune-mediated glomerular disease, which may gradually lead to kidney function failure.

Key Points: 
  • "Lupus Nephritis is the most common secondary immune-mediated glomerular disease, which may gradually lead to kidney function failure.
  • "Zetomipzomib can modulate innate and acquired immune responses to down regulate inflammation, which is differentiated from direct immunosuppression.
  • "This partnership with Everest Medicines is an important milestone in the development of zetomipzomib," said John Fowler, co-founder and CEO of Kezar.
  • In addition to LN, Everest and Kezar have the opportunity to collaborate on future clinical trials and indications for the continued development of zetomipzomib.

Alpine Immune Sciences Announces Initiation of Dosing in 240 mg IgA Nephropathy Cohort of Povetacicept Clinical Study (RUBY-3)

Retrieved on: 
Wednesday, August 30, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Hypersensitivity, Alpine, Immunoglobulin A, IgA nephropathy, ALPN, Immunoglobulin G, Hypogammaglobulinemia, SMC, Autoimmunity, Safety, Inflammation, Vaccine

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the successful initiation of the second IgA nephropathy (IgAN) dose cohort in RUBY-3, a phase 1b/2a study in autoimmune glomerulonephritis.

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 successful initiation of the second IgA nephropathy (IgAN) dose cohort in RUBY-3, a phase 1b/2a study in autoimmune glomerulonephritis.
  • Safety Monitoring Committee (SMC) review has determined that repeat dosing of povetacicept in the first IgAN dose cohort (80 mg subcutaneously once every 4 weeks) has been safe and well-tolerated to date, with no serious or severe adverse events, no events of hypogammaglobulinemia (IgG
  • Dose escalation has been endorsed, and enrollment of the second IgAN dose cohort (240 mg subcutaneously every 4 weeks) has been initiated.
  • “We look forward to providing more detailed clinical updates later this year in appropriate scientific forums.”

Selecta Biosciences Reports Second Quarter 2023 Financial Results and Updates on Strategic Initiative Designed to Maximize Stockholder Value Associated with SEL-212 Economics

Retrieved on: 
Thursday, August 17, 2023
Partnership, Swedish Orphan Biovitrum, Astellas Pharma, Serum, Telephone, Investigational New Drug, Immunoglobulin A, Antibody, AAV, Congress, Development, Methylmalonic acidemia, Selecta, IgA nephropathy, Investment, European, Administration, Immunoglobulin G, European Alliance of Associations for Rheumatology, EULAR, Research, BLA, Gout, European Alliance, Combination, Pharmaceutical industry, Vaccine, Rheumatology, Patient

WATERTOWN, Mass., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, today reported financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • As part of this initiative, the Company plans to:
    Continue to Advance SEL-212 in Patients with Chronic Refractory Gout in Partnership with Sobi.
  • The decrease was primarily the result of the capital prioritization initiative that was enacted in the second quarter of 2023.
  • Net (Loss) Income: For the second quarter of 2023, Selecta reported net loss of $11.4 million, or basic net loss per share of $(0.07).
  • Selecta’s management will host a conference call at 8:30 AM ET today to provide a corporate update and review the Company’s second quarter 2023 financial results and strategic updates.