Dr. Allen Davidoff reports

XORTX COMMENCES GOUT PROGRAM NDA DISCUSSIONS WITH THE FDA

XORTX Therapeutics Inc. has submitted a Type C meeting request with the U.S. Food and Drug Administration regarding the company's XRx-026 program for the treatment of gout. Development of Xorlo, the company's proprietary drug formulation of oxypurinol, has advanced to the point where a Type C meeting and discussion with the FDA are warranted. The purpose of this meeting is to review the XRx-026 program and its readiness for submission of a new drug application (NDA) to gain marketing approval for Xorlo in the United States using the FDA's 505(b)2 development pathway.

Dr. Allen Davidoff, XORTX's chief executive officer, commented: "The key elements of the XRx-026 program have advanced sufficiently to warrant a robust program review with the FDA. Having completed the work the FDA requested be conducted on oxypurinol in an approval letter issued previously, this Type C meeting will determine the FDA's position prior to submitting a NDA for final marketing approval. The meeting is expected to be held within 75 days of the FDA's receipt of the request. The prospect of helping individuals with gout that have otherwise few therapeutic options, combined with the fact that this program may be revenue positive within the next two years, is compelling."

The company will provide updates on the progress of the XRx-026 gout program when additional information is available.

About gout

In the United States, approximately 44 million individuals have circulating uric acid above the normal range and approximately 9.2 million individuals have symptomatic gout. Gout is an inflammatory arthritis that is triggered by the crystallization of uric acid in tissues, particularly the joints. Gout flares cause severe pain, reduced quality of life, decreased physical function, increased health care costs and lost economic productivity. Furthermore, gout is strongly associated with other serious conditions such as myocardial infarction, Type 2 diabetes, chronic kidney disease and premature mortality.

About the XRx-026 program and Xorlo

The XRx-026 program is developing Xorlo -- a proprietary formulation of oxypurinol to treat individuals suffering from gout. At present, oral xanthine oxidase inhibitors (XOIs) are the preferred therapeutic option used to inhibit the production of uric acid and decrease high uric acid levels in gout patients. Allopurinol is the most commonly prescribed XOI, with approximately 3.3 million prescriptions written annually in the United States. Although effective, 3 per cent to 5 per cent of patients cannot tolerate allopurinol. An alternative XOI, febuxostat, was launched in 2009 in the United States with the hope of treating individuals with gout and particularly those who were allopurinol intolerant. While febuxostat achieved peak sales of approximately $450-million (U.S.), it was issued a black box warning due to its associated risk of sudden cardiovascular death, and its use declined significantly. Additionally, Xorlo can address the unmet medical needs of allopurinol-intolerant patients and accelerating its NDA approval is now XORTX's priority.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: (1) the company's lead program XRx-026 program for the treatment of gout; (2) the XRx-008 program for ADPKD; and (3) XRx-101 for acute kidney and other acute organ injury associated with respiratory virus infections. In addition, the company is developing XRx-225, a preclinical stage program for Type 2 diabetic nephropathy. XORTX is working to advance products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, the company is dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

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