oxypurinol (XRx-101) / Xortx Therap - LARVOL DELTA

XORTX Provides Update on FDA Type B Meeting Request (GlobeNewswire) - "XORTX Therapeutics Inc...is pleased to announce it has received responses from the US Food and Drug Administration (the 'FDA') and clarified key steps for a new drug application ('NDA') for the Company’s novel proprietary formulation of oxypurinol for the treatment of gout. The Type B meeting conducted by the FDA, included review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence..."

FDA event • Gout

XORTX Therapeutics Inc. (BIO 2022) - "is a pharmaceutical company with two clinically advanced products in development – XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD), XRx-101 for Coronavirus / COVID-19 infection and XRx-225 is a pre-clinical stage program for Type 2 Diabetic Nephropathy (T2DN). At XORTX Therapeutics, we are dedicated to developing medications to improve the quality of life and future health of patients. Additional information on XORTX Therapeutics is available at www.xortx.com."

Autosomal Dominant Polycystic Kidney Disease • Diabetes • Diabetic Nephropathy • Genetic Disorders • Infectious Disease • Nephrology • Novel Coronavirus Disease • Polycystic Kidney Disease • Renal Disease • Type 2 Diabetes Mellitus

Pentoxifylline and Oxypurinol: Potential Drugs to Prevent the "Cytokine Release (Storm) Syndrome" Caused by SARS-CoV-2? (PubMed, Curr Pharm Des) - "Pentoxifylline and oxypurinol are licensed drugs used for diseases other than COVID-19 and, therefore, phase I clinical trials would not be necessary for administration to SARS-CoV2- infected people. It would be worth trying their potential effects against hyperinflammatory response to SARS-CoV2 infection."

Journal • Acute Respiratory Distress Syndrome • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pancreatitis • Pneumonia • Respiratory Diseases • Systemic Inflammatory Response Syndrome

XORTX Files U.S. FDA Pre-IND Meeting Request for XRx-101 (Oxypurinol) COVID-19 Program and Pre-IND Meeting Submission (GlobeNewswire) - "XORTX Therapeutics Inc....is pleased to announce that the Company has filed its pre-IND (Investigational New Drug) meeting request with the U.S. FDA. This filing initiates formal communications with the U.S. FDA regarding development of the Company’s proprietary formulation of XRx-101 (Oxypurinol) for the treatment and prevention of acute kidney injury (AKI) associated with COVID-19 coronavirus infection."

FDA event • Infectious Disease • Novel Coronavirus Disease

XORTX Partners with Mount Sinai’s Icahn School of Medicine on US-based Clinical Trial in COVID-19 (GlobeNewswire) - "XORTX Therapeutics Inc....is pleased to announce a partnership with the Icahn School of Medicine at Mount Sinai, New York to study the incidence of Acute Kidney Injury and Hyperuricemia in patients hospitalized with COVID-19. This partnership....focused on evaluation of more than 5,600 individuals with COVID-19 infection....XRx-101 may ameliorate the severity of COVID-19 infection comorbidity, mortality, and damage to kidneys."

Licensing / partnership • New trial • Infectious Disease • Novel Coronavirus Disease

XORTX Provides Program Update Regarding XRx-008 for ADPKD and XRx-101 for Coronavirus / COVID-19 Programs (GlobeNewswire, XORTX Therapeutics Inc.) - "XORTX Therapeutics Inc....is pleased to provide the following update on its clinical stage programs to treat chronic autosomal dominant polycystic kidney disease (ADPKD) - XRx-008 and acute kidney injury (AKI) associated with COVID-19 Infection – XRx-101.....Submitted to the FDA Coronavirus Treatment Accelerated Program (CTAP) a development and data plan regarding a COVID-19 package and received guidance to submit a pre-IND package for review. Pre-IND submission preparations are underway....XORTX has also initiated discussions with the US Medical Countermeasures Group associated with the U.S. Government’s Biomedical Advanced Research and Development Authority (BARDA) and separately with the National Institute of Health (NIH)."

IND • Novel Coronavirus Disease