$XRTX XORTX Opens an IND for XRx-008 Program for Autosomal Dominant Polycystic Kidney Disease
https://www.globenewswire.com/news-release/20...sease.html
FDA Provides All Clear Notification for IND and Bridging Pharmacokinetics Study ●
CALGARY, Alberta, May 05, 2022 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a clinical stage pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce that the Company has received official notification from the US Food and Drug Association (“FDA”) that the Company’s recent IND (Investigative New Drug) application has been reviewed and cleared. Accompanying this notification is a “Study May Proceed Letter” regarding the XRX-OXY-101 bridging pharmacokinetics study (“PK Study”). This FDA approval of the IND supports the Company’s XRx-008 program for treatment of progressing kidney disease due to autosomal dominant polycystic kidney disease (“ADPKD”).
XORTX is focused on advancing XRx-008 through the PK Study as well as registration clinical trials for the treatment of ADPKD. At the present time, very few approved therapeutic options exist to treat progressive kidney disease in individuals due to this disease. There is reason for hope, however, as recent clinical study evidence confirms that uric acid is an independent risk factor for progression of progressive kidney disease and that managing purine metabolism and serum uric acid concentrations can positively affect the kidney health thereby improving the lives of patients with progressive kidney disease.
Dr. Allen Davidoff, CEO of XORTX stated, “The grant of this IND for our XRx-008 program for our Company’s lead program for ADPKD, provided an important opportunity for the FDA to review, comment and confirm XORTX’s development plans. This grant is an important step in the Company’s progress. We are grateful for the FDA review and communications as we optimize the critical path steps needed to proceed with our clinical trial programs and seek marketing approval of XRx-008 for ADPKD patients.”
XORTX’s XRx-008 therapeutic development program for ADPKD, is advancing a proprietary composition of xanthine oxidase inhibitor, to manage aberrant purine metabolism and chronically high serum uric acid concentration. At present, there are few therapeutic options available to treat progressing kidney disease due to ADPKD. XORTX’s IND provided a robust overview of program status with respect to chemistry, manufacturing, pharmacology, toxicology, and clinical work to date and will facilitate formal communications with the FDA regarding development of XRx-008 for the treatment of progressive kidney disease due to ADPKD. Further announcements regarding future meetings with the FDA, other regulatory agencies will be forthcoming.
XORTX is currently conducting our clinical trial - XRX-OXY-101 - a “bridging pharmacokinetics” study. Part 1 of the PK Study involves dosing under fasted conditions. Part 2 measures the effect of food on pharmacokinetics (PK) and Part 3 is a multiple dose PK evaluation. Safety evaluation is also an important aspect of the XRX-OXY-101 clinical trial. The PK Study is designed to permit XORTX to characterize the safety and relative bioavailability of the XRx-008 program formulations. Knowledge gained during the conduct of this trial will provide critical guidance regarding the oral dose for our planned registration trial in ADPKD. Additionally, the PK Study will provide fundamental information for the 505(b)2 filing of the XRx-008 program.
https://www.globenewswire.com/news-release/20...sease.html
FDA Provides All Clear Notification for IND and Bridging Pharmacokinetics Study ●
CALGARY, Alberta, May 05, 2022 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a clinical stage pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce that the Company has received official notification from the US Food and Drug Association (“FDA”) that the Company’s recent IND (Investigative New Drug) application has been reviewed and cleared. Accompanying this notification is a “Study May Proceed Letter” regarding the XRX-OXY-101 bridging pharmacokinetics study (“PK Study”). This FDA approval of the IND supports the Company’s XRx-008 program for treatment of progressing kidney disease due to autosomal dominant polycystic kidney disease (“ADPKD”).
XORTX is focused on advancing XRx-008 through the PK Study as well as registration clinical trials for the treatment of ADPKD. At the present time, very few approved therapeutic options exist to treat progressive kidney disease in individuals due to this disease. There is reason for hope, however, as recent clinical study evidence confirms that uric acid is an independent risk factor for progression of progressive kidney disease and that managing purine metabolism and serum uric acid concentrations can positively affect the kidney health thereby improving the lives of patients with progressive kidney disease.
Dr. Allen Davidoff, CEO of XORTX stated, “The grant of this IND for our XRx-008 program for our Company’s lead program for ADPKD, provided an important opportunity for the FDA to review, comment and confirm XORTX’s development plans. This grant is an important step in the Company’s progress. We are grateful for the FDA review and communications as we optimize the critical path steps needed to proceed with our clinical trial programs and seek marketing approval of XRx-008 for ADPKD patients.”
XORTX’s XRx-008 therapeutic development program for ADPKD, is advancing a proprietary composition of xanthine oxidase inhibitor, to manage aberrant purine metabolism and chronically high serum uric acid concentration. At present, there are few therapeutic options available to treat progressing kidney disease due to ADPKD. XORTX’s IND provided a robust overview of program status with respect to chemistry, manufacturing, pharmacology, toxicology, and clinical work to date and will facilitate formal communications with the FDA regarding development of XRx-008 for the treatment of progressive kidney disease due to ADPKD. Further announcements regarding future meetings with the FDA, other regulatory agencies will be forthcoming.
XORTX is currently conducting our clinical trial - XRX-OXY-101 - a “bridging pharmacokinetics” study. Part 1 of the PK Study involves dosing under fasted conditions. Part 2 measures the effect of food on pharmacokinetics (PK) and Part 3 is a multiple dose PK evaluation. Safety evaluation is also an important aspect of the XRX-OXY-101 clinical trial. The PK Study is designed to permit XORTX to characterize the safety and relative bioavailability of the XRx-008 program formulations. Knowledge gained during the conduct of this trial will provide critical guidance regarding the oral dose for our planned registration trial in ADPKD. Additionally, the PK Study will provide fundamental information for the 505(b)2 filing of the XRx-008 program.
