Oxipurinol

XORTX Highlights Achievements of 2023 and Preparation for Registration Clinical Trial

Retrieved on: 
Tuesday, March 19, 2024
Consultant, Nephrology, Provisional application, XRX, Partnership, Chemistry, Kidney disease, Tablet, Orphan, Bryant University, University, EMA, Polycystic kidney disease, Trial of the century, Oxipurinol, MBA, GMP, Diet, PKD, Treatment, Society, Therapy, Patent, Rensselaer Polytechnic Institute, FDA, Marketing, Diagnosis, American Society of Nephrology, Uric acid, Pharmaceutical industry

Dr. Allen Davidoff, CEO of XORTX, stated, “2023 marked a year of substantial clinical, technological and regulatory progress, establishing the foundation for the Company’s 2024 goals.

Key Points: 
  • Dr. Allen Davidoff, CEO of XORTX, stated, “2023 marked a year of substantial clinical, technological and regulatory progress, establishing the foundation for the Company’s 2024 goals.
  • Each of these milestones permit the next step in the Company’s clinical development plan, being a “registration” clinical trial – XRX-OXY-201 in pursuit of accelerated approval and support of the Company’s lead program XRx-008 program for ADPKD.
  • Chemistry and Manufacturing, Clinical and Pre-Clinical Highlights – Produced drug substance for oxypurinol production and produced GMP drug substance; confirmed XORLO™ formulation, produced enhanced bioavailability and produced clinical supply of tablets for clinical trials.
  • August 29, 2023 – XORTX submitted an Orphan Drug Designation application to the EMA for the treatment of ADPKD.

XORTX Submits a New Patent for the Treatment of Chronic Kidney Disease

Retrieved on: 
Wednesday, January 3, 2024
DN, Immunoglobulin A, IgA nephropathy, Kidney disease, Diabetic nephropathy, Uric acid, Trial of the century, Oxipurinol, Therapy, Autosome, Pharmacokinetics, Focal segmental glomerulosclerosis, Patent, Chronic kidney disease, ADPKD, Treating, Study, Polycystic kidney disease, XRX, Safety, Lupus nephritis, XOI, CKD, Pharmaceutical industry

CALGARY, Alberta, Jan. 03, 2024 (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, announces submission of a new patent for the treatment of chronic kidney disease (“CKD”).

Key Points: 
  • CALGARY, Alberta, Jan. 03, 2024 (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, announces submission of a new patent for the treatment of chronic kidney disease (“CKD”).
  • This patent is designed to protect new discoveries and strategies for the treatment of individuals with varied degrees of kidney function in the setting of CKD.
  • This patent application is intended to claim new opportunities to enhance how the xanthine oxidase inhibitor class of drugs may be dosed in the future.
  • Importantly, how to further improve the safe and effective administration of this class of drugs, including oxypurinol.”

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

Retrieved on: 
Thursday, 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.

XORTX Submits Orphan Drug Designation Application to the European Medicines Agency (EMA) to Treat Progressive Kidney Disease

Retrieved on: 
Tuesday, August 29, 2023
Marketing, ODD, European Medicines Agency, Acute kidney injury, COMP, Oxipurinol, Research, Science, Committee, EMA, Polycystic kidney disease, Patient, Hyperuricemia, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Kidney disease, Autosome, Pharmaceutical industry, ADPKD

CALGARY, Alberta, Aug. 29, 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, announces that it has submitted an Orphan Drug Designation application for XORLO™ to the European Medicines Agency (the “EMA”). The “orphan-drug designation request is for the use of XORTX’s patented unique proprietary formulation of oxypurinol – XORLO™ – for the treatment of autosomal dominant polycystic kidney disease (ADPKD)”.

Key Points: 
  • CALGARY, Alberta, Aug. 29, 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, announces that it has submitted an Orphan Drug Designation application for XORLO™ to the European Medicines Agency (the “EMA”).
  • The “orphan-drug designation request is for the use of XORTX’s patented unique proprietary formulation of oxypurinol – XORLO™ – for the treatment of autosomal dominant polycystic kidney disease (ADPKD)”.
  • The orphan drug designation process (“ODD”) initiated with the submission of this application and is made to the EMA’s COMP (Committee for Orphan Medicinal Products) office.
  • It also follows on receipt of ODD status granted by the U.S. Food and Drug Administration in April 2023.

XORTX Announces Results of Annual and Special Meeting of Shareholders

Retrieved on: 
Thursday, June 29, 2023
Smythe, US Foods, University, Interim, CSE, TSX Venture Exchange, Oxipurinol, Meeting, Polycystic kidney disease, CPA, FDA, Therapy, Remuneration, News, Kidney disease, Autosome, Pharmaceutical industry

CALGARY, Alberta, June 29, 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 results of its annual and special meeting of shareholders (the “Meeting”) held Wednesday, June 28, 2023.

Key Points: 
  • CALGARY, Alberta, June 29, 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 results of its annual and special meeting of shareholders (the “Meeting”) held Wednesday, June 28, 2023.
  • A total of 7,482,990 common shares of the Company were represented at the Meeting, representing approximately 41.6% of the total number of common shares of the Company issued and outstanding.
  • “This year’s shareholder meeting saw the departure of Jacqueline Le Saux who decided to not stand for re-election.
  • The Board extends its appreciation to Jacqueline for her 2+ years of service to XORTX.

XORTX Announces Receipt of FDA Orphan Drug Designation to Treat Autosomal Dominant Kidney Disease

Retrieved on: 
Friday, April 21, 2023
Orphan Drug Act of 1983, US Foods, Drug development, Marketing, ODD, Cyst, American Society of Nephrology, PKD, Oxipurinol, Plasma protein binding, Polycystic kidney disease, Patient, Hyperuricemia, ADPKD, Rare, FDA, Therapy, Society, Food, Kidney disease, Autosome, Pharmaceutical industry

CALGARY, Alberta, April 21, 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 grant of Orphan Drug Designation for oxypurinol – “orphan-drug designation request of oxypurinol is granted for treatment of autosomal dominant polycystic kidney disease”.

Key Points: 
  • CALGARY, Alberta, April 21, 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 grant of Orphan Drug Designation for oxypurinol – “orphan-drug designation request of oxypurinol is granted for treatment of autosomal dominant polycystic kidney disease”.
  • The orphan drug designation process (“ODD”) begins with an application to the US Food and Drug Administration (“FDA”) Orphan Drug Designation office, and is accompanied by a comprehensive package that includes the basic science, analysis of addressable number of individuals with autosomal dominant polycystic kidney disease (“ADPKD”) and description of the patients projected to be helped by a therapy.
  • Dr. Allen Davidoff stated, “Orphan drug designation represents a major milestone for the Company in pursuit of marketing approval for XORLOTM, our proprietary formulation of oxypurinol, and the XRx-008 program for ADPKD.
  • A tax credit of 25% of the qualified clinical drug testing costs awarded upon drug approval is also possible.

XORTX Announces Submission of Orphan Drug Designation Request for XRx-008 Program to Treat Autosomal Dominant Kidney Disease

Retrieved on: 
Wednesday, February 1, 2023
Marketing, Society, ADPKD, Food, Plasma protein binding, Kidney disease, PKD, Oxipurinol, Orphan Drug Act of 1983, Drug development, Cyst, Hyperuricemia, American Society of Nephrology, ODD, FDA, US Foods, Autosomal dominant polycystic kidney disease, Degenerative disease, Therapy, Pharmaceutical industry

CALGARY, Alberta, Feb. 01, 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 it submitted an Orphan Drug Designation (“ODD”) Request to the US Food and Drug Administration (“FDA”) for the XRx-008 program for the treatment of Autosomal Dominant Polycystic Kidney Disease (“ADPKD”).

Key Points: 
  • CALGARY, Alberta, Feb. 01, 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 it submitted an Orphan Drug Designation (“ODD”) Request to the US Food and Drug Administration (“FDA”) for the XRx-008 program for the treatment of Autosomal Dominant Polycystic Kidney Disease (“ADPKD”).
  • XORTX anticipates updates regarding the ODD application and will provide announcements as information becomes available.
  • XORTX intends to pursue these benefits as part of the drug development for XRx-008 for treatment of ADPKD, pending designation of the ODD Request.
  • A tax credit of 25% of the qualified clinical drug testing costs awarded upon drug approval is also possible.

XORTX Announces Positive Topline Results from XRX-OXY-101 Clinical Trial

Retrieved on: 
Thursday, January 19, 2023
Kidney disease, Therapy, Study, Pharmacokinetics, XRX, Oxipurinol, ADPKD, Pharmaceutical industry, EU

CALGARY, Alberta, Jan. 19, 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 positive topline results from the XRX-OXY-101 – Bridging Pharmacokinetics Clinical Trial (the “Study”) characterizing the pharmacokinetics of the Company’s proprietary formulation of oral oxypurinol, XORLOTM.

Key Points: 
  • CALGARY, Alberta, Jan. 19, 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 positive topline results from the XRX-OXY-101 – Bridging Pharmacokinetics Clinical Trial (the “Study”) characterizing the pharmacokinetics of the Company’s proprietary formulation of oral oxypurinol, XORLOTM.
  • Results from the Study showed that XORLOTM was well tolerated across the various dosing regimens.
  • No safety issues were identified in any of the four parts of the Study on the 88 subjects who received drug.
  • Dr. Allen Davidoff, CEO of XORTX, stated, “We are pleased to have achieved this important milestone in the development of XORLOTM, the Company’s proprietary oral formulation of oxypurinol.

XORTX Announces New Proof of Concept Data in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Retrieved on: 
Thursday, December 8, 2022
Kidney disease, Uric acid, XOI, Kidney failure, Heart, Oxipurinol, TKV, XO, Polycystic kidney disease, Time-invariant system, Fibrosis, Society, University of Colorado Colorado Springs, Nephrology, Therapy, Xanthine oxidase, Creatinine, University, American Society of Nephrology, Pharmaceutical industry, Dietary supplement, Hyperuricemia, ADPKD

If Xanthine oxidase (XO) is expressed in the mouse RC/RC model of polycystic kidney disease (“PKD”), a model for human ADPKD.

Key Points: 
  • If Xanthine oxidase (XO) is expressed in the mouse RC/RC model of polycystic kidney disease (“PKD”), a model for human ADPKD.
  • How increased circulating uric acid concentrations in the cardiovascular system affect kidney weight, heart, inflammatory status and fibrosis.
  • How inhibiting of XO by XORTX’s proprietary XRx-008 formulation of oxypurinol, XORLOTM, attenuates total kidney volume, cyst genesis and cyst growth rate.
  • Pkd1RC/RC mouse develops a slowly progressing polycystic kidney disease with embryonic cyst initiation, present cystic lesions in the liver and elongated primary cilia in collecting ducts.

XORTX Announces Completion of Screening and Enrollment in Bridging Pharmacokinetics Study

Retrieved on: 
Monday, November 28, 2022
Knowledge, US Foods, COVID-19, Unitary state, Incidence, Diagnosis, Kidney disease, Pharmacokinetics, Food, Kidney, Polycystic kidney disease, Uric acid, Health Canada, EMA, Cyst, European Medicines Agency, Safety, Therapy, Oxipurinol, Autosome, Chronic pain, TSX Venture Exchange, Patient, Analysis, Coronavirus, XRX, Xanthine oxidase, International, News, Health, Absorption, Form, Quality of life, Fibrosis, Consultant, Diabetes, Study, Clinical trial, FDA, Metabolism, XO, Pharmaceutical industry, ADPKD

The Company anticipates completion of dosing in the XRX-OXY-101 clinical trial in the coming weeks and additional announcements of topline results of the final two parts of the Study in the near future.

Key Points: 
  • The Company anticipates completion of dosing in the XRX-OXY-101 clinical trial in the coming weeks and additional announcements of topline results of the final two parts of the Study in the near future.
  • The key data emerging from this Study will be essential to our pharmacokinetic modeling and selection of a safe dose for individuals in the planned XRX-OXY-301 phase 3 clinical trial.
  • Oxypurinol is a purine based xanthine oxidase inhibitor with important pharmacologic characteristics ideal for administration to individuals with ADPKD.
  • At XORTX, we are dedicated to developing medications to improve the quality of life and future health of patients.