Xanthine oxidase

Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Date of authorisation: 28/03/2019, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Date of authorisation: 28/03/2019, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Date of authorisation: 28/03/2019, Revision: 5, Status: Authorised

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

Retrieved on: 
Thursday, November 2, 2023

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 Sponsored Study Selected for Presentation at the American Society of Nephrology – Kidney Week 2023

Retrieved on: 
Thursday, September 28, 2023

The abstract outlines study results from a mouse model of polycystic kidney disease challenged with low to moderate circulating uric acid.

Key Points: 
  • The abstract outlines study results from a mouse model of polycystic kidney disease challenged with low to moderate circulating uric acid.
  • The study also identifies a novel inflammatory profile as a possible mechanism of injury inducing an increased cyst index and kidney enlargement.
  • XORTX will provide further details of the study at the time of the presentation during the first week of November at the ASN meeting scheduled for November 2, 2023.
  • XORTX granted patents and additional patent applications supporting the XRx-008 program are wholly owned by XORTX.”

XORTX Announces PKD Presentation

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Tuesday, June 6, 2023

CALGARY, Alberta, June 06, 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 presentation of scientific data underpinning the recent Orphan Drug Designation (“ODD”) at the PKD Foundation – “PKD Connect” meeting being held June 22-24, 2023 in Denver, Colorado.

Key Points: 
  • CALGARY, Alberta, June 06, 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 presentation of scientific data underpinning the recent Orphan Drug Designation (“ODD”) at the PKD Foundation – “PKD Connect” meeting being held June 22-24, 2023 in Denver, Colorado.
  • This annual meeting of the US PKD Foundation ( https://pkdcure.org/conference/ ) is attended by leading thought leaders, PKD foundation members, patient advocacy groups and medical researchers interested in autosomal dominant polycystic kidney disease (“ADPKD”).
  • Dr. Allen Davidoff stated: “This presentation will review the discoveries made by Dr. Charles Edelstein, with XORTX sponsorship.
  • The PKD annual meeting provides an opportunity to interact with patient groups, knowledge leaders in ADPKD research in the US and is an important step towards advancing the XRx-008 program.

XORTX Announces Type D Meeting with FDA to be held May 1, 2023

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Tuesday, March 14, 2023

CALGARY, Alberta, March 14, 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 submission of a Type D meeting request to the US Food and Drug Administration (“FDA”) and a response setting the date for a virtual meeting on May 1, 2023.

Key Points: 
  • Accompanying the Type D meeting request was a revised clinical trial protocol for XRX-OXY-301, a data update from the XRX-OXY-101 bridging pharmacokinetic clinical trial as well as a description of future clinical development program plans for XORLOTM, XORTX’s proprietary oxypurinol formulation, for the treatment of autosomal dominant polycystic kidney disease (“ADPKD”).
  • Prior discussions with the FDA and existing agency guidance permits accelerated approval for specified validated endpoints such as total kidney volume in ADPKD.
  • Submission of this revised clinical trial protocol, XRX-OXY-301, provides the opportunity for XORTX’s XRx-008 program to achieve earlier completion of our planned registration trial and importantly accelerate FDA marketing approval.
  • Dr. Allen Davidoff, CEO of XORTX stated, “XORTX is pleased to advance this discussion with the FDA regarding the path to accelerated approval for XORLOTM to treat individuals with a diagnosis of ADPKD.

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

Retrieved on: 
Thursday, December 8, 2022

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

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.

XORTX Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency

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Friday, November 25, 2022

Nasdaq Rule 5550(a)(2) requires the shares to maintain a minimum bid price of US$1.00 per share, and Nasdaq Rule 5810(c)(3)(A) provides that failure to meet such a requirement exists when the bid price of the shares is below US$1.00 for a period of 30 consecutive business days.

Key Points: 
  • Nasdaq Rule 5550(a)(2) requires the shares to maintain a minimum bid price of US$1.00 per share, and Nasdaq Rule 5810(c)(3)(A) provides that failure to meet such a requirement exists when the bid price of the shares is below US$1.00 for a period of 30 consecutive business days.
  • These notifications do not impact the Companys listing on the Nasdaq Capital Market at this time.
  • In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification to regain compliance with the minimum bid price requirement, during which time the shares will continue to trade on the Nasdaq Capital Market.
  • If at any time before the 180 calendar day period, the bid price of the shares closes at or above US$1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement and will consider such deficiency matters closed.

XORTX Therapeutics Appoints Stacy Evans, M.D., MBA as Chief Business Officer

Retrieved on: 
Wednesday, November 16, 2022

CALGARY, Alberta, Nov. 16, 2022 (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 appointment of Stacy Evans, M.D., MBA, as Chief Business Officer.

Key Points: 
  • CALGARY, Alberta, Nov. 16, 2022 (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 appointment of Stacy Evans, M.D., MBA, as Chief Business Officer.
  • For the past seven years, Dr. Evans has consulted at an executive level with small to mid-size private and public biopharmaceutical companies, including acting as Chief Business Officer for many clients.
  • Allen Davidoff, Ph.D., Chief Executive Officer of XORTX, stated, We are pleased to welcome Stacy to the team as Chief Business Officer.
  • Dr. Evans brings extensive large and small pharma licensing and M&A experience to XORTX and will lead our increasingly active commercial assessment and business development activities.

XORTX Presents New Proof of Concept Data at American Society of Nephrology

Retrieved on: 
Thursday, November 3, 2022

CALGARY, Alberta, Nov. 03, 2022 (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 a peer-reviewed abstract to be presented November 4, 2022 at the American Society of Nephrology (“ASN”) Annual Conference – Kidney Week.  The abstract presents new discoveries in two species – mouse and rat models of polycystic kidney disease (“PKD”) and reports original work showing the harmful consequence of chronically increased uric acid on both structure and function of kidneys. The Abstract “Raising Serum Uric Acid with a Uricase Inhibitor Worsens PKD in Rat and Mouse models” will be presented during the Session Title: Genetic Diseases of the Kidneys, by Dr. Charles Edelstein of the University of Colorado and Dr. Allen Davidoff, CEO of XORTX.  This presentation will report for the first time, that XORTX's XRx-008 formulation of Xanthine Oxidase inhibitor can substantially and significantly block the increase in kidney size associated with high circulating uric acid in a rodent model of polycystic kidney disease.

Key Points: 
  • The abstract presents the findings of studies conducted at the University of Colorado, by Dr. Charles Edelstein and the PKD research team.
  • Dr. Allen Davidoff, CEO of XORTX, stated, We are pleased to present these important new findings during the ASN Kidney Week 2022.
  • With these results presented today, XORTX now has the information required to prepare and pursue Orphan Drug Designation for XRx-008.
  • At XORTX, we are dedicated to developing medications to improve the quality of life and future health of patients.