- XORTX Therapeutics (XRTX) has received official notification from the US Food and Drug Association (FDA)
- The notification says that the company’s recent Investigative New Drug (IND) application has been reviewed and cleared
- Accompanying this notification is a “Study May Proceed Letter” regarding the XRX-OXY-101 bridging pharmacokinetic study
- This FDA approval of the IND supports the company’s XRx-008 program for the treatment of progressing kidney disease due to autosomal dominant polycystic kidney disease
- XORTX is a clinical-stage pharmaceutical company
- XORTX Therapeutics Inc. was up 16.837 per cent, trading at $2.29 at 10:34 AM ET
XORTX Therapeutics’ (XRTX) recent Investigative New Drug (IND) application has been cleared by the US Food and Drug Association (FDA).
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 the 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.
“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,” said Allen Davidoff, CEO of XORTX.
“This grant is an important step in the company’s progress, and 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,” he added.
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 the development of XRx-008 for the treatment of progressive kidney disease due to ADPKD.
XORTX is currently conducting its 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 the company’s planned registration trial in ADPKD.
ADPKD is a rare disease that affects more than 10 million individuals worldwide.ADPKD is typically diagnosed based on the expansion of fluid-filled cysts in the kidneys.
Over time, the increasing number and size of cysts can contribute to structural and functional changes to kidneys and is frequently accompanied by chronic pain which is a common problem for patients with ADPKD.
XORTX is a clinical-stage pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease.
XORTX Therapeutics Inc. was up 16.837 per cent, trading at $2.29 at 10:34 AM ET.
