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XORTX Therapeutics Inc. (NASDAQ: XRTX) is a bio-pharmaceutical company dedicated to developing and commercializing innovative therapies aimed at treating progressive kidney diseases worldwide. Headquartered in Calgary, Canada, XORTX focuses on addressing serious health conditions related to aberrant purine and uric acid metabolism, including diabetic nephropathy, polycystic kidney disease (PKD), and complications arising from diabetes and cardiovascular diseases.
The company has two lead programs targeting progressive kidney disease due to diabetes and PKD. Additionally, XORTX is actively involved in the development of uric acid-lowering agents to treat conditions like hypertension, insulin resistance, metabolic syndrome, and diabetes. Their pipeline includes xanthine oxidase inhibitors that show potential in managing diabetic nephropathy.
One of XORTX's strategic milestones is its alliance with Teijin Pharma Limited for the development of TMX-049, a promising xanthine oxidoreductase inhibitor. Another significant partnership is with the Icahn School of Medicine, focusing on studying acute kidney injury and hyperuricemia in patients hospitalized with COVID-19.
XORTX Therapeutics Inc. is at the clinical-stage of biotechnology, aiming to identify, develop, and potentially commercialize therapies that can slow or reverse the progression of chronic kidney diseases. Their focus includes addressing the immediate needs of individuals facing acute kidney injury (AKI) due to respiratory virus infections and exploring other opportunities where their intellectual property can mitigate various health issues.
XORTX Therapeutics Inc. (NASDAQ: XRTX) announced the successful completion of its Type B Pre-phase 3 meeting with the FDA on September 16, 2022. This meeting followed the submission of a comprehensive Pre-Phase-3 Briefing Package on July 28, 2022, outlining advancements in the XRx-008 program for treating autosomal dominant polycystic kidney disease (ADPKD). The FDA's feedback focused on optimizing trial design with minimal concerns, paving the way for a single phase 3 clinical trial aimed at marketing approval. CEO Dr. Allen Davidoff emphasized the importance of FDA guidance in refining their clinical trial strategy.
XORTX Therapeutics announced the acceptance of a study abstract for presentation at the American Society of Nephrology Kidney Week 2022. The study, titled “Raising Serum Uric Acid with a Uricase Inhibitor Worsens PKD in Rat and Mouse Models”, reveals that increased serum uric acid can accelerate injury in Polycystic Kidney Disease (PKD). Dr. Charles Edelstein will present this finding, supporting XORTX’s XRx-008 program. The company anticipates further updates around the conference and aims to expand its patent portfolio based on these findings.
XORTX Therapeutics announced positive topline results from its Pharmacokinetics Bridging Study – XRX-OXY-101 Part 2, highlighting a significant increase in the oral bioavailability of its proprietary oxypurinol formulation when taken with food. The study also confirmed a clean safety profile with no drug-related adverse events. This successful study paves the way for the planned Phase 3 registration trial in autosomal dominant polycystic kidney disease (ADPKD), with patient dosing expected in the first half of 2023.
XORTX Therapeutics has filed a Pre-Phase 3 Meeting Briefing Package with the FDA regarding its XRx-008 program for treating autosomal dominant polycystic kidney disease (ADPKD). The virtual meeting is set for September 16, 2022. Recent R&D milestones include the manufacturing of clinical quality GMP oxypurinol and improvements in drug formulation. This progress positions XORTX favorably for key discussions with the FDA about essential clinical steps ahead of filing a New Drug Application (NDA).
XORTX Therapeutics Inc. (NASDAQ: XRTX) announced positive outcomes from its 2022 Annual and Special Meeting of Shareholders on July 20, 2022. Approximately 4.5 million shares were voted, representing 35% of outstanding shares. All proposed resolutions passed with near-unanimous support, including the election of seven directors and the re-appointment of Smythe LLP as auditors. The meeting also saw the approval of a 10% rolling stock option plan, underscoring shareholder confidence in the company's future.
XORTX Therapeutics (NASDAQ: XRTX) announced that it has submitted a request for a scientific advice review to the European Medicines Agency (EMA) regarding its XRx-008 program for autosomal dominant polycystic kidney disease (ADPKD). This submission aims to discuss the program's status and plans for a global phase 3 trial, which follows recent successful R&D activities, including increased oral bioavailability of XRx-008. The company aims to enhance the drug's approval potential, benefiting over 10 million worldwide affected by ADPKD.
XORTX Therapeutics has announced positive topline results from Part 1 of its XRX-OXY-101 Pharmacokinetics Bridging Study, demonstrating a significant increase in oral bioavailability of its proprietary oxypurinol formulations. The trial, which had no adverse events, is a precursor to a planned phase 3 registration trial focused on treating autosomal dominant polycystic kidney disease (ADPKD). Key objectives include determining the optimal formulation and dosing regimen. Part 1 confirmed improved bioavailability and established a pharmacokinetics dataset that aids in future drug development.
XORTX Therapeutics Inc. (NASDAQ: XRTX) has submitted a type B pre-Phase 3 meeting request to the FDA, anticipated in about 70 days. This request follows successful R&D activities for its XRx-008 program targeting autosomal dominant polycystic kidney disease (ADPKD). Key milestones include GMP oxypurinol manufacturing and improved drug formulation. CEO Dr. Allen Davidoff emphasized the meeting's importance for discussing the registration trial protocol and New Drug Application (NDA) for their lead product, which aims to slow renal function decline in ADPKD patients.
XORTX Therapeutics Inc. (NASDAQ: XRTX) announced a "Fireside Chat" hosted by CEO Dr. Allen Davidoff on June 22, 2022, at 11 am EST. The session will present updates on innovative therapies aimed at treating progressive kidney diseases, specifically focusing on the company's clinical products: XRx-008 for Autosomal Dominant Polycystic Kidney Disease and XRx-101 for acute kidney injury related to COVID-19. Investors can register for the event through a provided link. XORTX is committed to improving patient quality of life through targeted therapies addressing purine metabolism and uric acid production.
XORTX Therapeutics Inc. (NASDAQ: XRTX) announced its participation in the BIO International Convention 2022, from June 13-16, 2022, in San Diego. CEO Dr. Allen Davidoff will present the company's progress and future plans on June 13 at 2 PM. The event aims to enhance outreach to pharmaceutical partners, with over 30 meetings scheduled. XORTX is developing innovative therapies for progressive kidney disease, including XRx-008 for ADPKD and XRx-101 targeting COVID-19 related acute kidney injury. The company focuses on improving patient quality of life.