CALGARY, Alberta, April 20, 2022 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a pharmaceutical company focused on developing innovative therapies to treat progressive renal failure, is pleased to announce receipt of Small and Medium Enterprise (“SME“) Statute for the European Union (the “EU”). This status is applicable for the European Medicines Agency (“EMA”) related interactions confirmed by the SME Office – Regulatory Science and Innovation Working Group. The SME status enables the Company to reduce its costs as it enters into discussions with the American Food and Drug Administration (“FDA”) and the EMA regarding the upcoming Phase 3 registration trial of XRX-OXY-301 for XRx-008 and other clinical programs.
SME status allows XORTX to benefit from significant financial incentives such as a 90% reduction in EMA fees for scientific advice, clinical study protocol design, statistical considerations and endpoints , quality inspections and fee waivers for future regulatory filings before and after EMA clearance such as Orphan Drug Designation.
“This is an important step in our regulatory strategy which includes consultation with the EMA as we continue to develop our European development strategy,” said Dr. Allen Davidoff, CEO.
XORTX is currently conducting its clinical trial – XRX-OXY-101 – a “transition pharmacokinetics” study. This study is a three-part, single-dose study; fed or fasted; then, a comparative study of bioavailability and crossover multi-dose pharmacokinetics in healthy volunteers. It is designed to allow XORTX to characterize the relative safety and bioavailability of the XRx-008 formulation. Knowledge gained during the conduct of this trial will provide guidance regarding the oral dose of XRx-008 for the company’s planned registrational trial in autosomal dominant polycystic kidney disease (“ADPKD”). In addition, this study will provide data to support future new drug application (“nes”) FDA and EMA submissions. This study should start in the second quarter of 2022.
XRX-OXY-301 Registration test in ADPKD. XRX-OXY-301 is a multisite, multinational, placebo-controlled study in ADPKD patients with active kidney disease. The objective of this study is to evaluate the safety and efficacy of XRx-008 over a period of 24 months and to investigate the ability of xanthine oxidase inhibition to decrease the rate of decline in the rate of glomerular filtration. Approximately 350 patients will be enrolled. This study is expected to begin in the second half of 2022, subject to SPA (special protocol evaluation) negotiations with the FDA.
About the SME
The category of micro, small and medium-sized enterprises (SMEs) is made up of enterprises which employ less than 250 people and which have an annual turnover not exceeding 50 million euros and/or an annual balance sheet total not exceeding not exceeding 43 million euros.
The European Medicines Agency is an agency of the European Union responsible for the evaluation and monitoring of medicines. Prior to 2004, it was known as the European Medicines Evaluation Agency or European Medicines Evaluation Agency.
The EMA plays a central role in facilitating the development and authorization of medicines across Europe. The SME initiative encourages innovation by small businesses such as XORTX. The company will be registered in the public SME register of the EMA. One of the objectives of this online register is to facilitate and promote interaction, partnership and networking between SMEs.
About XORTX Therapeutics Inc.
XORTX is a pharmaceutical company with two clinically advanced products in development: 1) our lead program in XRx-008 for ADPKD; and 2) our secondary program in XRx-101 for acute kidney injury and other acute organ injury associated with coronavirus/COVID-19 infection. Additionally, XRx-225 is a preclinical-stage program for type 2 diabetic nephropathy. XORTX is working to advance its products into clinical development that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit the production of uric acid. At XORTX, we are dedicated to developing medicines to improve the quality of life and future health of patients. Additional information about XORTX is available at www.xortx.com.
|For more information, please contact:|
|Allen Davidoff, CEO||Nick Rigopulos, Director of Communications|
|[email protected] or +1 403 455 7727||[email protected] or +1 617 901 0785|
The TSX Venture Exchange and the Nasdaq have neither approved nor disapproved of the contents of this press release. No stock exchange, securities commission or other regulatory authority has approved or disapproved of the information contained herein.
This press release may contain express or implied forward-looking statements pursuant to Canadian and United States federal securities laws. These forward-looking statements and their implications are based solely on the current reasonable expectations of XORTX’s management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. . Except as otherwise required by law, XORTX undertakes no obligation to issue revisions or updates to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen events. More detailed information on the risks and uncertainties affecting XORTX is contained in the most recent annual information form filed by the company and in the management report for its last financial reporting period filed on the company’s SEDAR profile (www.sedar.com ) and under the heading “Risk Factors” in XORTX’s registration statement on Form F-1 filed with the Securities and Exchange Commission (“SEC”) available at the SEC’s website, www.sec.gov .