XORTX Therapeutics Inc. - XRTX STOCK NEWS

XORTX Therapeutics announces that it has received an all-clear notification from the FDA for its IND application concerning the XRX-OXY-101 bridging pharmacokinetics study, supporting its XRx-008 program aimed at treating autosomal dominant polycystic kidney disease (ADPKD).

This approval is pivotal for advancing clinical trials and securing marketing approval for XRx-008, which targets high serum uric acid levels—a critical factor in kidney disease progression. The ongoing study will provide essential data for future regulatory submissions.

XORTX Therapeutics Inc. has successfully completed recruitment for the first part of the XRX-OXY-101 bridging pharmacokinetics study for its XRx-008 program aimed at treating autosomal dominant polycystic kidney disease (ADPKD). A total of 32 subjects have been dosed to evaluate the pharmacokinetics and bioavailability of the proprietary formulations of oxypurinol. The study will also gather essential data for a future 505(b)2 filing. ADPKD affects over 10 million people globally and the company aims to develop therapies to slow kidney function decline.

XORTX Therapeutics has received Small and Medium Enterprise (SME) status in the EU, which will benefit its EMA interactions. This designation offers a 90% fee reduction for various regulatory services, aiding in the upcoming XRX-OXY-301 phase 3 trial for XRx-008. The trial aims to evaluate the safety and efficacy of XRx-008 in patients with ADPKD over 24 months, enrolling an estimated 350 patients. XORTX is also conducting a pharmacokinetics study, XRX-OXY-101, to assess the drug's safety and bioavailability, starting in Q2 2022.

XORTX Therapeutics Inc. announced the receipt of a no objection letter from Health Canada for its XRX-OXY-101 clinical bridging pharmacokinetics study. The study aims to identify the optimal formulation for oxypurinol and assess food effect, safety, and pharmacokinetics. This information is critical for advancing toward a phase 3 trial in Autosomal Dominant Polycystic Kidney Disease (ADPKD). Dr. Allen Davidoff emphasized that this milestone accelerates the development of the XRx-008 program towards potential marketing approvals for treating progressive kidney disease.

XORTX Therapeutics Inc. has announced the granting of a patent for its proprietary formulations in treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The patent, titled 'Formulations of Xanthine Oxidase Inhibitors,' provides 20 years of protection for XRx-008, aimed at addressing the unmet medical needs in progressive kidney diseases. Approximately 3 million individuals globally suffer from ADPKD. This patent strengthens XORTX's intellectual property portfolio in the U.S., paving the way for expanded clinical trials and partnership opportunities.

XORTX Therapeutics Inc. has filed an investigational new drug (IND) application with the FDA for its XRx-008 program targeting autosomal dominant polycystic kidney disease (ADPKD). This IND supports the initiation of clinical trials for a combination of uric acid-lowering agents aimed at slowing disease progression. Currently, few treatment options exist for ADPKD, with only one approved drug, Tolvaptan. The company aims to advance XRx-008 to provide better outcomes for patients, as recent evidence indicates that high uric acid levels are a risk factor for kidney function decline.

XORTX Therapeutics has submitted a Patent Cooperation Treaty application for a patent titled “Compositions and Methods for Enhancing Anti-Viral Therapies”. This patent focuses on addressing purine metabolism and hyperuricemia, particularly in individuals at risk for severe COVID-19 outcomes, including those with obesity and chronic kidney disease. The submission is based on retrospective clinical data suggesting the potential for uric acid-lowering agents to inhibit SARS-CoV-2 replication. The company clarifies that it does not claim to cure or contain COVID-19.

XORTX Therapeutics has submitted a clinical trial application for its XRX-OXY-101 bridging pharmacokinetics study to Health Canada. This study aims to evaluate the optimal formulation for circulating oxypurinol concentrations, assess food effects on bioavailability, and understand safety and pharmacokinetics. The results will inform future oral dosing for the planned phase 3 trial targeting Autosomal Dominant Polycystic Kidney Disease (ADPKD). The outcomes will also support marketing submissions to the FDA and EMA.

XORTX Therapeutics Inc. (NASDAQ: XRTX) reported significant achievements in 2021 and outlined strategic goals for 2022. Key highlights include raising $20 million through equity financings, advancement of XRx-008 for ADPKD, and XRx-101 targeting acute kidney injury from COVID-19. The company secured several patents and engaged in partnerships with notable institutions like Mount Sinai Hospital. Upcoming plans include initiating clinical trials and seeking orphan drug designation to enhance its product pipeline aimed at improving patient outcomes in kidney diseases.