Sevelamer

Unicycive Therapeutics Delivers Multiple Presentations on Oxylanthanum Carbonate (OLC) and UNI-494 at the European Renal Association Congress

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星期二, 五月 28, 2024
Patient, European Renal Association, Pharmacokinetics, ATP, SAD, AKI, Acute kidney injury, Kidney disease, LOS, Dialysis, Index, DGF, BID, Therapy, Histology, Safety, NGAL, Chronic kidney disease, MD, Congress, Animal, CKD, Rat, Incidence, Biomarker, Kidney, Nanotechnology, Poster, TID, Hyperphosphatemia, Aes, Sevelamer, ERA, Pharmaceutical industry

LOS ALTOS, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that several presentations were delivered on the Company’s two product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61st European Renal Association (ERA) Congress. OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator initially targeting acute kidney injury (AKI).

Key Points: 
  • UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator initially targeting acute kidney injury (AKI).
  • This data compliments our previously reported data in the intravenous (IV) form of UNI-494.
  • The study concluded that UNI-494 is a potential candidate for prevention of delayed graft function (DGF) and other clinical conditions resulting from AKI.
  • Oxylanthanum Carbonate (OLC) Presentation Details:
    Results: This oral presentation evaluated the effects of tenapanor and OLC on phosphate excretion in rats.

Ardelyx Presents Additional Data at the NKF 2024 Spring Clinical Meetings on XPHOZAH® (tenapanor)

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星期四, 五月 16, 2024
Perception, Patient, CSR, RD, Comorbidity, Food, Dialysis, PAI, National Kidney Foundation, Ageing, CDN, Reduction, Safety, Nephrology, AUC, Chronic kidney disease, MD, CKD, Hyperphosphatemia, Sevelamer, Post hoc analysis, NKF, Pharmaceutical industry

Ardelyx is also hosting an Exhibitor Showcase discussing hyperphosphatemia management.

Key Points: 
  • Ardelyx is also hosting an Exhibitor Showcase discussing hyperphosphatemia management.
  • 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.
  • Tenapanor demonstrated similar efficacy and safety profiles in adult patients on dialysis regardless of age group and comorbidity.
  • In the Phase 3 study OPTIMIZE, 80% of patients enrolled answered a question characterizing their phosphate management regimen as improved, unchanged or worsened on tenapanor.

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

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星期五, 十一月 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.

Carina Biotech Appoints Two New U.S. Based Biotechnology Executives to the Board of Directors

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星期一, 六月 5, 2023
CLL, Gaucher's disease, Medicine, University, Chronic lymphocytic leukemia, SLL, Acute lymphoblastic leukemia, Biotechnology, Food, Food and Drug Administration, MBA, Providence College, University of Bern, Pharmacyclics, Audit committee, Waldenström macroglobulinemia, Genzyme, Patient, Mantle cell lymphoma, Hyperphosphatemia, Cero, Bone marrow, Kite Pharma, Fabry disease, FDA, Therapy, Suffolk University, Imiglucerase, IND, Sevelamer, Safety, Pharmaceutical industry, Ibrutinib

ADELAIDE, Australia, June 05, 2023 (GLOBE NEWSWIRE) -- Carina Biotech (Carina), a cell therapy immuno-oncology company, today announced the appointment of Michael S. Wyzga, M.B.A., and Remus Vezan M.D., Ph.D., to its Board of Directors.

Key Points: 
  • ADELAIDE, Australia, June 05, 2023 (GLOBE NEWSWIRE) -- Carina Biotech (Carina), a cell therapy immuno-oncology company, today announced the appointment of Michael S. Wyzga, M.B.A., and Remus Vezan M.D., Ph.D., to its Board of Directors.
  • Mr. Wyzga is an accomplished biotechnology executive who brings to Carina’s Board over two decades of expertise as a leader and advisor to life sciences companies.
  • “We are delighted to welcome two seasoned executives that bring a wealth of expertise in the U.S. biotechnology industry as independent Directors to the Carina Board,” remarked Leanna Read, Ph.D., Chair of Carina’s Board of Directors.
  • Their insight and contribution have been invaluable.”
    Mr. Gosling will continue to support Carina on the Governance, People and Remuneration Committee, whilst Mr. Latham will remain Company Secretary.

Ardelyx Presents Positive Data Further Supporting Efficacy and Safety of XPHOZAH® (tenapanor) at National Kidney Foundation 2023 Spring Clinical Meetings

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星期三, 四月 12, 2023
Chronic kidney disease, Diarrhea, Sevelamer, FAS, Hyperphosphatemia, Incidence, SP, NKF, National Kidney Foundation, White, CKD, Dialysis, Safety, Pharmaceutical industry, Serum, Patient

WALTHAM, Mass., April 12, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced multiple presentations covering additional positive clinical observations of XPHOZAH at the National Kidney Foundation (NKF) 2023 Spring Clinical Meetings, which is taking place in Austin, TX from April 11-15, 2023. Ardelyx has completed three successful Phase 3 pivotal clinical trials, and two additional Phase 4 open-label clinical trials (OPTIMIZE and NORMALIZE) for XPHOZAH, an investigational, novel phosphate absorption inhibitor studied in adult patients with chronic kidney disease (CKD) on maintenance dialysis seeking to control their serum phosphate. XPHOZAH was discovered and developed by Ardelyx.

Key Points: 
  • This analysis included data from all three Phase 3 registration studies: a 12-week monotherapy study (BLOCK), a 52-week monotherapy study (PHREEDOM) and a four-week combination study (AMPLIFY).
  • Diarrhea was the most common adverse event reported by patients treated with XPHOZAH, with a higher incidence rate in these patients.
  • Results from both NORMALIZE and OPTIMIZE trials support the long-term safety of XPHOZAH.
  • Adverse events were similar to those of previous studies, with diarrhea being the most common adverse event.

Glyscend Therapeutics Appoints Biotech Industry Veteran Michael Wyzga to its Board of Directors

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星期四, 三月 30, 2023
Health, Diabetes, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Gaucher's disease, Genzyme, OncoMed, Chronic lymphocytic leukemia, MBA, Providence College, Strategic planning, Type 2, Patient, Hyperphosphatemia, Fabry disease, Therapy, Suffolk University, Imiglucerase, Sevelamer, Pharmaceutical industry, Management

Glyscend Therapeutics , a clinical-stage biotechnology company pioneering a new generation of orally administered polymer therapies, today announced the appointment of Michael Wyzga to its Board of Directors.

Key Points: 
  • Glyscend Therapeutics , a clinical-stage biotechnology company pioneering a new generation of orally administered polymer therapies, today announced the appointment of Michael Wyzga to its Board of Directors.
  • Mr. Wyzga brings over two decades of deep experience leading and advising life sciences companies to the Glyscend Board.
  • “We are thrilled to welcome Mike, a distinguished biotech industry expert, to the Glyscend team,” said Ashish Nimgaonkar, M.D., President and CEO of Glyscend.
  • I, along with the rest of the Board, look forward to his partnership.”
    Mr. Wyzga added, “I’m pleased to join the Glyscend Board of Directors during this exciting time for the company.

Unicycive Reports Key Findings from Market Research with Nephrologists

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星期三, 七月 20, 2022
Renal osteodystrophy, Osteoporosis, ESRD, Diabetes, Trademark, Absorption, Kidney disease, Kidney, GLOBE, CKD, Mortality, Acute kidney injury, U.S. Securities and Exchange Commission, Dialysis, Calcium, Research, Fracture, Cardiovascular disease, Compliance, Hyperphosphatemia, Bone pain, Private Securities Litigation Reform Act, Chronic kidney disease, Atherosclerosis, Risk, Failure, Therapy, Safety, COVID-19, Strategic management, SHPT, Nephrology, Biotechnology, Artery, MBA, FDA, Company, Security (finance), Gastrointestinal tract, Patient, Nasdaq, Bone disease, Coronavirus, Hypertension, Sevelamer, Face, LLC, Pharmacotherapy, LOS, Lanthanum carbonate, Pharmaceutical industry, Genzyme, Rastogi

LOS ALTOS, Calif., July 20, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced the results from a primary market research study conducted on behalf of the company by Reason Research, LLC. The study was a discrete-choice model (“conjoint”) analysis in which 100 US-based nephrologists were presented with various phosphate binder attributes, including efficacy, safety/tolerability, pill burden, composition (calcium or non-calcium based), and dose form (chewable or swallowed), in a trade-off methodology to determine comparative prescribing preferences for currently available phosphate binders and Renazorb®, Unicycive’s product under development.

Key Points: 
  • Key findings from the research:
    Nephrologists estimate that they will prescribe Renazorb (pending FDA approval) for a market-leading 34% of their dialysis patients requiring phosphate binder therapy.
  • This market research with nephrologists, the predominant prescribers of phosphate binders, provides strong validation for our belief in the best-in-class potential of the Renazorb product profile, said Doug Jermasek, MBA, Executive Vice President, Corporate Strategy at Unicycive.
  • These survey results give us further confidence in the significant market opportunity for Renazorb.
  • Unicycive is conducting important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.

Unicycive Announces Acceptance of Two Preclinical Data Sets to be Presented at the European Renal Association Congress

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星期三, 三月 16, 2022
Therapy, Sevelamer, Kidney, Biotechnology, Nephrology, Hyperphosphatemia, Acute kidney injury, Safety, Pharmaceutical industry

Unicycive is making continued progress advancing our clinical program for Renazorb toward regulatory approval and these preclinical safety and efficacy data compared with the global standard of care (sevelamer) will support those efforts.

Key Points: 
  • Unicycive is making continued progress advancing our clinical program for Renazorb toward regulatory approval and these preclinical safety and efficacy data compared with the global standard of care (sevelamer) will support those efforts.
  • Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases.
  • Unicycives lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.For more information, please visit www.unicycive.com .

VFMCRP announces positive results of phase-III clinical trial of Velphoro® in China

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星期五, 四月 30, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Chemistry, Physical sciences, Chemical elements, Phosphate binders, Dietary minerals, Vifor Pharma, Sevelamer, Sucroferric oxyhydroxide, Phosphorus, XC2, Calcium, the PA-CL-CHINA-01 study, Velphoro®, THE PA-CL-CHINA-01 STUDY, VELPHORO®

The study met its primary endpoint demonstrating non-inferiority versus sevelamer carbonate in the change from baseline in serum phosphorus levels at week 12.\nDr.

Key Points: 
  • The study met its primary endpoint demonstrating non-inferiority versus sevelamer carbonate in the change from baseline in serum phosphorus levels at week 12.\nDr.
  • In 2020, Velphoro\xc2\xae became a global leader by value in the calcium-free phosphate binder market2.\n1 Zhang et al.
  • Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives.
  • Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210429005950/en/\n'

US Nephrologists Report Few Gains in the CKD-MBD Market for Akebia's Auryxia, Amgen's Parsabiv, and Opko's Rayaldee Despite Reports That They Would Like to Expand Use of All Three Products

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星期二, 六月 25, 2019
Medical specialties, Medicine, Clinical medicine, Phosphate binders, Kidney diseases, RTT, Anemias, Sanofi, Sevelamer, Sucroferric oxyhydroxide, Nephrology, Kidney

Use of sevelamer (Renvela/sevelamer generics) has held steady during this time, although nephrologists do report projected offsets in favor of Auryxia and Velphoro in the near future.

Key Points: 
  • Use of sevelamer (Renvela/sevelamer generics) has held steady during this time, although nephrologists do report projected offsets in favor of Auryxia and Velphoro in the near future.
  • Spherix quarterly updates for the renal anemia market are scheduled to be released this week.
  • Subscriptions to the service are available for the following markets: Bone and Mineral Metabolism, Renal Anemia, Hyperkalemia, and Polycystic Kidney Disease.
  • All company, brand or product names in this document are trademarks of their respective holders.