SGLT2

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

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Venerdì, Novembre 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.

Bexacat™ (bexagliflozin tablets), the First and Only Tablet to Treat Feline Diabetes, Named “Overall Cat Health Product Of The Year” In 2023 Pet Innovation Awards

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Giovedì, Novembre 2, 2023
Science, FDA, Research, Retail, Veterinarian, NYSE, Innovation, Food, Diabetes, Vomiting, Human, Cat, Weight loss, Diarrhea, Elanco, Service, DM, SGLT2, Argyreia nervosa, Liver, Type 1 diabetes, Pancreatitis, ELAN, Urine, Dehydration, Disease, Risk, Farmer, Lethargy, Depression, Diabetic ketoacidosis, Pet, Diagnosis, Death, Glucose, Coma, Insulin, Pharmaceutical industry, Health, Housing

Bexacat is a once-daily tablet that works to lower blood sugar by increasing urine excretion of glucose through inhibition of sodium-glucose cotransporter 2 (SGLT2).

Key Points: 
  • Bexacat is a once-daily tablet that works to lower blood sugar by increasing urine excretion of glucose through inhibition of sodium-glucose cotransporter 2 (SGLT2).
  • “Bexacat removes some of the traditional challenges associated with treating feline diabetes and is a more efficient option for today’s on-the-go pet owner lifestyle.
  • Bexacat is needle-free and dosed to felines at a minimum weight of 6.6 lbs in order to ensure dosing accuracy.
  • The 2023 Pet Innovation Awards attracted more than 2,000 nominations from around the world.

Boehringer Ingelheim achieves major milestone in chronic kidney disease: aldosterone synthase inhibitor on top of empagliflozin delivers promising results in Phase II trial

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Venerdì, Novembre 3, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Standard of care, University of Washington School of Medicine, Hyperkalemia, Oxford, Pressure, Albuminuria, SGLT2, Kidney, HIV disease progression rates, Society, American Society of Nephrology, Population 1 (album), Chronic kidney disease, Phase, Boehringer Ingelheim, Clinical trial, ASN, Hypertension, Aldosterone, Risk, Kidney disease, University, Serum, ASI, CKD, Safety, End organ damage, Patient, Ingelheim am Rhein, Pharmaceutical industry, UACR, Medicine

Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi).

Key Points: 
  • Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi).
  • “With over 1 billion people worldwide affected by these conditions, the potential to help reduce the pressure on healthcare systems and patients is immense.
  • We are proud to be leading the way in this field and are excited to move forward with the upcoming Phase III trial to further investigate the potential of this novel compound on top of standard of care including empagliflozin."
  • Hyperkalemia occurred at a rate typical for a CKD population,1 and most episodes did not require medical treatment or BI 690517 discontinuation.1

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

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Venerdì, Ottobre 13, 2023
FSGS, American Society of Nephrology, IgA nephropathy, Proteinuria, Abstract, OLE, Society, Heart Protection Study, SGLT2, Kidney, Impact, NEPTUNE, Therapy, Jay Traver, ASN, Immunoglobulin A, PROTECT, SAN, Patient, Focal segmental glomerulosclerosis, Quality of life, Pharmaceutical industry

SAN DIEGO, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the Company will present 11 abstracts, including two late-breaking oral presentations, at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 2-5, 2023.

Key Points: 
  • SAN DIEGO, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the Company will present 11 abstracts, including two late-breaking oral presentations, at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 2-5, 2023.
  • Presentations will highlight the long-term efficacy and tolerability data of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) from the PROTECT Study, as well as the potential for use of FILSPARI as a first-line treatment in newly diagnosed IgAN patients and in combination with SGLT2 inhibitors.
  • The Company will also present data on the efficacy and tolerability of sparsentan in focal segmental glomerulosclerosis (FSGS) and pediatric proteinuric glomerular diseases, as well as provide insights into patient quality of life and the impact of proteinuria on kidney survival in rare kidney diseases.
  • “The data we and our collaborators are presenting at ASN are a testament to our collective dedication to enhance our scientific understanding of kidney diseases to improve patients’ lives,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.

US Nephrologists Embrace Current IgA Nephropathy Therapies, Yet a Thriving Pipeline Signals Fierce Market Evolution Ahead

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Venerdì, Ottobre 13, 2023
Atrasentan, Physician, Acquisition, Launch, Shanda, BioCryst Pharmaceuticals, Risk, CKD, Data, SGLT2, Alexion, Patient, Jay Traver, FDA, Phase, Immunoglobulin A, Benchmarking, Proteinuria, New Drug Application, Attention, Nephrology, Qualitative research, ACE, Vera, Alnylam Pharmaceuticals, Pharmaceutical industry, Chinook, IgA nephropathy, Novartis, Budesonide

Despite the welcomed additions to the armamentarium, data from Spherix’s 2023 Market Dynamix: IgA Nephropathy (US) service reveals that nephrologists still consider there to be a high unmet need for new therapies.

Key Points: 
  • Despite the welcomed additions to the armamentarium, data from Spherix’s 2023 Market Dynamix: IgA Nephropathy (US) service reveals that nephrologists still consider there to be a high unmet need for new therapies.
  • As a result, access has understandably become a more prominent and pressing concern, overshadowing the actual availability of disease-targeted treatment options.
  • The landscape of the IgAN pipeline is in a constant state of evolution, with one of the most recent developments coming from Novartis.
  • Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.

Data Demonstrating Financial Impact of INPEFA® (Sotagliflozin) to be Presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 National Meeting

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Mercoledì, Ottobre 11, 2023
Nexus, Food, Doctor of Philosophy, Expo Hall, Risk, Hospital, MPH, Orlando World Center Marriott, SGLT2, SGLT1, AMCP, Diabetes, Academy of Managed Care Pharmacy, Heart failure, National meetings of the League of Communists of Yugoslavia, Cypress, Regulation of tobacco by the U.S. Food and Drug Administration, Health, Patient, Pharmaceutical industry, Policy

THE WOODLANDS, Texas, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that findings from two studies on the cost-effectiveness and budget impact of INPEFA® (sotagliflozin) will be presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 National Meeting on October 16-19, 2023, in Orlando, Florida.

Key Points: 
  • Studies address cost-effectiveness and budget impact of INPEFA, an inhibitor of SGLT2 and SGLT1
    THE WOODLANDS, Texas, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that findings from two studies on the cost-effectiveness and budget impact of INPEFA® (sotagliflozin) will be presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 National Meeting on October 16-19, 2023, in Orlando, Florida.
  • Both posters will be on display Tuesday, October 17, 2023, from 4:00 – 7:00 p.m.
  • ET during the Opening Night Reception at the Orlando World Center Marriott, Expo Hall, Cypress 1 and 2, and will be included in the meeting’s first session of poster presentations on Wednesday, October 18, 2023, from 11:00 a.m. – 12:30 p.m.
  • ET in the same location.

Tenaya Therapeutics Presents Encouraging New Clinical and Preclinical Data from HDAC6 Inhibitor Program TN-301 for the Potential Treatment of Heart Failure with Preserved Ejection Fraction at the 2023 HFSA Annual Scientific Meeting

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Lunedì, Ottobre 9, 2023
2013 Tour de France, Stage 1 to Stage 11, Pharmacokinetics, Inhibitor, Inflammation, Risk, Metabolism, Safety, SGLT2, Selectivity, Clinical trial, MAD, Disease, HDAC6, Therapy, SAD, Heart failure, Suitability analysis, Tubulin, Acetylation, Plasma, Potential, PD, Stage 2, Distribution function (measure theory), Patient, Oxidative stress, Pharmaceutical industry, Vaccine, Tenaya, Heart failure with preserved ejection fraction

SOUTH SAN FRANCISCO, Calif. and CLEVELAND, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today released new data for TN-301 at the 2023 Heart Failure Society of America (HFSA) Annual Scientific Meeting. TN-301 is Tenaya’s highly selective small molecule inhibitor of histone deacetylase 6 (HDAC6) being developed for the potential treatment of heart failure with preserved ejection fraction (HFpEF).

Key Points: 
  • TN-301 is Tenaya’s highly selective small molecule inhibitor of histone deacetylase 6 (HDAC6) being developed for the potential treatment of heart failure with preserved ejection fraction (HFpEF).
  • "TN-301 continues to generate promising early data as a differentiated candidate for the treatment of HFpEF, a form of heart failure with few treatment options and unacceptably low survival rates.
  • In Stage 1, participants received single ascending doses (SAD) of either TN-301 at doses ranging from 1mg – 700mg or placebo.
  • Plasma exposure and target engagement observed in this healthy participant study met or exceeded those required for maximal efficacy in preclinical studies.

DaVita Statement on GLP-1 and Potential Implications on Chronic Kidney Disease

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Giovedì, Ottobre 12, 2023
Cardiovascular disease, SELECT, Urine, Novo Nordisk, Death, Research, Risk, CKD, IA Financial Group, Mortality, SGLT2, Health, Type 2, FLOW, Type 2 diabetes, Kidney, Proteinuria, Chronic kidney disease, Clinical trial, DaVita Inc., Patient, C-peptide, GFR, News, Kidney disease, ACE, Pharmaceutical industry, Medical imaging

The following statement can be attributed to Dr. Jeff Giullian, chief medical officer for DaVita Inc.

Key Points: 
  • The following statement can be attributed to Dr. Jeff Giullian, chief medical officer for DaVita Inc.
    "We've been closely monitoring the developments related to GLP-1s, and are excited about the potential benefits this class of drugs could have on society and patients with kidney disease.
  • We will continue monitoring closely as further evidence becomes available to identify the potential benefit of GLP-1s to those afflicted with kidney disease.
  • In the meantime, DaVita remains focused on providing exceptional patient care and advancing the practice of kidney care."
  • The trial sought to demonstrate benefits for the composite endpoint comprised of five separate endpoints: death from kidney disease; death from cardiovascular disease; sustained reduction in GFR by at least 50%; progression to stage 5 CKD; and initiation of chronic kidney replacement therapy.

Renalytix Reports Full Year Fiscal 2023 Results

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Giovedì, Settembre 28, 2023
Insurance, LSE, ICR, Diabetes, Metabolism, Telephone, Appointment, EGFR, Prescription, Risk, SALT, Black, SGLT2, EDT, Dialysis, CareFirst BlueCross BlueShield, Medicare, Community health, PIN, Standard of care, Patient, Wake Forest, UACR, Diabetic nephropathy, FDA, Mid-Atlantic (United States), Kidney disease, BST, Medical device, Health insurance, Pharmaceutical industry, Cryptocurrency, Medical imaging, Obesity

LONDON and SALT LAKE CITY, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, reports its financial results for the fiscal year ended June 30, 2023.

Key Points: 
  • LONDON and SALT LAKE CITY, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, reports its financial results for the fiscal year ended June 30, 2023.
  • Deployment and risk stratification by KidneyIntelX was associated with escalation in clinical actions taken to optimize cardio-metabolic-kidney health including medications and referrals.
  • Over 5,000 KidneyIntelX tests performed in fiscal year 2023, up 55% from the prior year
    Investors are advised to read the results for the 12 months ended 30 June 2023, which have been filed with the U.S. Securities and Exchange Commission on Form 10-K concurrently with this results announcement.
  • Upon registering, a dial-in number and unique PIN will be provided in order for interested parties to join the conference call.

Poxel Reports Financial Results for First Half 2023 and Provides a Corporate Update

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Martedì, Settembre 26, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Diabetes, ULF, Adrenoleukodystrophy, Prescription, Plasma, JPY, Patent, Patient, Serono, Merck, R, Estonia, POC, Pioglitazone, Sumitomo Group, Disease, Male, NASH, Pharmacokinetics, Sumitomo Pharma, EPO, Fatty liver disease, Leukodystrophy, Marshal of France, Rare, Kidney, Conference, Safety, Abstract, DPP4, ALD, JDS, Merck Serono, European Patent Office, Biomarker, DSM-IV codes, AMN, IRIS, Scientific communication, United States patent law, SGLT2, VLCFA, EUR, European Patent Convention, Pharmacology, TZD, Pharmaceutical industry, Medical device, Imeglimin, Euronext

POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2023 and provided a corporate update.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2023 and provided a corporate update.
  • For the Sumitomo Pharma FY 2023, as a conservative assumption in line with Sumitomo Pharma’s forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • On July 5th, Poxel was chosen as the winner of the 2023 edition of the I-nov contest for its program in ALD.
  • This recently issued patent provides additional protection through 2041, with the potential for an additional 5 years through patent term extension.