EXHIBIT 99.1

XORTX Provides Corporate Update

Synopsis of 2021 Achievements and Key Activities for 2022

CALGARY, Alberta, Jan. 31, 2022 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a pharmaceutical therapeutics company focused on developing innovative therapies to treat progressive kidney disease, is pleased to take this opportunity to provide an update on the Company’s progress in 2021 and provide insights on 2022 goals.

Dr. Allen Davidoff stated, “I would like to thank our Board of Directors, employees, vendors and shareholders for their continued support as we continue to develop XORTX into a high value company. Our significant progress in 2021 laid the foundation for our 2022 goals which should contribute to further de-risking our technology and the creation of significant shareholder value going forward.”

In 2021, the Company made significant progress advancing its strategic plan in key areas, including the non-clinical development of its proprietary XRx-008 and XRx-101 and strengthening the corporate leadership team. Most notably, the Company completed two equity financings raising gross proceeds of ~$20 million setting the stage for advancement of XRx-008, a late-stage clinical program focused on demonstrating the potential of our novel therapy for autosomal dominant polycystic kidney disease (“ADPKD”) and XRx-101, for use in treating patients infected with coronavirus COVID-19 with associated acute kidney injury (“AKI”). XRx-008 is the development name given to XORTX's proprietary oral formulation of oxypurinol, and shows increased oral bioavailability compared to oxypurinol alone and XRx-101 is a second oral formulation of oxypurinol, for use in treating patients infected with the coronavirus COVID-19 with associated AKI.

Clinical and Pre-Clinical Highlights

2021 was a breakout year for XORTX in terms of validation of our technology and value creation for shareholders including a successful partnership with Mount Sinai Hospital and patent grants and filings including the following:

Organizational Highlights

Along with the US listing on Nasdaq and uplisting to the TSX Venture Exchange, 2021 also saw the transformation and bolstering of XORTX’s board, management team, clinical team and advisory board with the following appointments:

Financial Highlights

The completion of approximately $20M CAD in financings brought key institutional shareholders to XORTX:

Goals for 2022

In 2022, XORTX is focused on advancing XRx-008 into a clinical trial, the submission of an Orphan Drug Designation, initiation of special protocol assessment discussions with the US Food and Drug Administration (“FDA”) and continue formulation development for other kidney disease applications. To achieve these objectives, XORTX’s action plan includes:

  1. Initiate XRX-OXY-101 Bridging Study. This study is a three-part, single-dose; fed or fasted; then, multi-dose crossover comparative bioavailability and pharmacokinetic study in healthy volunteers. It is designed to permit XORTX to characterize the safety and relative 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 our planned registration trial in ADPKD. Additionally, this study will provide data to support future New Drug Application (“NDA”) submissions to the FDA and the European Medicines Agency (“EMA”). This study is planned to start in the second quarter of 2022.

  2. Initiate XRX-OXY-102 Bridging Study. This study is a multi-dose crossover comparative bioavailability and pharmacokinetic study in healthy volunteers. It is designed to permit XORTX to characterize the safety and relative bioavailability of the XRx-101 formulation options. Knowledge gained during the conduct of this trial will provide guidance regarding the oral dose of XRx-101 for future clinical and commercial planning. Additionally, this study will provide data to support future NDA submissions to the FDA and EMA. This study is planned to start in the first half of 2022.

  3. Complete Orphan Drug Designation. Current research being conducted will be used to file for orphan drug designation in 2022.

  4. Commence XRX-OXY-301 Registration trial in ADPKD. XRX-OXY-301 is a multi-site, multi-national, placebo controlled, study in ADPKD patients with progressing stage 2 or 3 kidney disease. The objective of this study is to evaluate the safety and effectiveness of XRx-008 over a 24-month period and study the ability of xanthine oxidase inhibition to decrease the rate of decline of glomerular filtration rate. An estimated 300 patients will be enrolled. This study is planned to start in the second half of 2022, subject to SPA negotiations with the FDA.

  5. Ongoing CMC Work. In parallel to the XRX-OXY-101 and XRX-OXY-102 studies, XORTX will be focused on performing the necessary scale-up, process validation and stability as part of the CMC requirements for the filing of the Investigative New Drug (“IND”), as well as future clinical and commercial supplies. All development will be performed according to current GMP methodology. This work will be ongoing throughout 2022 and 2023.

  6. Preparation of 505(b)(2) IND. In parallel with initiation of XRX-OXY-101 a 505(b)2 based IND is expected to be submitted in the first half of 2022 for the XRx-008 program.

  7. Activities Related to Potential Commercial Launch. In preparation for a possible NDA filing in 2025 in the U.S. for XRx-008, XORTX is planning to conduct additional commercialization studies, including nephrologist, patient, payer, pricing and/or reimbursement studies, as well as product brand name selection and filings, and plans for launch. This work will be ongoing from 2022 to 2025.

  8. Activities Related to European Registration. XORTX intends to establish guidance from the European Union for path to approval in the European Union, including required clinical studies and reimbursement conditions. This work will be ongoing from 2022 to 2025.

To achieve the above goals, XORTX will continue to pursue non-dilutive and dilutive funding and expand discussions to partner with a major pharma / biotech companies with a global reach. XORTX will also increase financial and healthcare conference participation to further strengthen and expand our investor base.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with two clinically advanced products in development – XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD), XRx-101 for acute kidney and other acute organ injury associated with Coronavirus / COVID-19 infection as well as XRx-225 which is a pre-clinical stage program for Type 2 Diabetic Nephropathy (T2DN). XORTX is working to advance its clinical development stage products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, we are dedicated to developing medications to improve the quality of life and future health of patients. Additional information on XORTX is available at www.xortx.com.

For further information, please contact:

Allen Davidoff, CEONick Rigopulos, Director of Communications
adavidoff@xortx.com or +1 403 455 7727nick@alpineequityadv.com or +1 617 901 0785


The TSX Venture Exchange and Nasdaq have neither approved nor disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward Looking Statements

This press release contains express or implied forward-looking statements pursuant to Canadian and U.S. Federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of XORTX only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, XORTX undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting XORTX is contained in the Company’s Management’s Discussion and Analysis for the interim period ended September 30, 2021 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 on the SEC's website, www.sec.gov.