# EDGAR Filing Document

**Accession Number:** 0001729214
**File Stem:** 0001171843-23-000011
**Filing Date:** 2023-1
**Character Count:** 11216
**Document Hash:** bad6c2cb1063b8556da5782ac3240287
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001171843-23-000011.hdr.sgml**: 20230103

**ACCESSION NUMBER**: 0001171843-23-000011

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 2

**CONFORMED PERIOD OF REPORT**: 20230103

**FILED AS OF DATE**: 20230103

**DATE AS OF CHANGE**: 20230103

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** XORTX Therapeutics Inc.
- **CENTRAL INDEX KEY:** 0001729214
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** A1
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40858
- **FILM NUMBER:** 23500735

**BUSINESS ADDRESS:**
- **STREET 1:** SUITE 2400 - 745 THURLOW STREET
- **CITY:** VANCOUVER
- **STATE:** A1
- **ZIP:** V6E 0C5
- **BUSINESS PHONE:** 403-607-2621

**MAIL ADDRESS:**
- **STREET 1:** SUITE 2400 - 745 THURLOW STREET
- **CITY:** VANCOUVER
- **STATE:** A1
- **ZIP:** V6E 0C5

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**Form 6-K**

**REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934**

**For the month of January 2023**

**Commission File Number: 001-40858**

**XORTX Therapeutics Inc.**

**3710 – 33rd Street NW, Calgary, Alberta, T2L 2M1**

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F [ X ] &nbsp;&nbsp;&nbsp;&nbsp; Form 40-F [ ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): <u>&nbsp;&nbsp;&nbsp;&nbsp;</u> 

**Note:** Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): <u>&nbsp;&nbsp;&nbsp;&nbsp;</u> 

**Note:** Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

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**SIGNATURE**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | **XORTX Therapeutics Inc.&nbsp;&nbsp;&nbsp;&nbsp;** | **XORTX Therapeutics Inc.&nbsp;&nbsp;&nbsp;&nbsp;** |
|  | (Registrant) | (Registrant) |
| Date: January 3, 2023 | By: | <u>&nbsp;&nbsp;&nbsp;&nbsp;*/s/ Allen Davidoff*</u> |
|  | Name: | Allen Davidoff |
|  | Title: | Chief Executive Officer |

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<u>**EXHIBIT INDEX**</u>

[99.1](exh_991.htm) [News Release dated January 3, 2023](exh_991.htm)

## Exhibit 99.1

**EXHIBIT 99.1**

**XORTX Files New Provisional Patent to Diagnose and Treat Individuals Most at Risk of Polycystic Kidney Disease Progression**

CALGARY, Alberta, Jan. 03, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("**XORTX**" or the "**Company**") (NASDAQ: XRTX \| TSXV: XRTX \| Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the submission of a Patent Cooperation Treaty (PCT) patent application seeking international patent protection for the patent entitled **"Compositions and Methods for Diagnosis, Treatment and Prevention of Kidney Disease"**.

This patent is based on key discoveries by XORTX's independent scientific research partners suggesting that an important diagnostic and therapeutic opportunity exists. This patent application builds upon new discoveries in polycystic disease and more specifically polycystic kidney disease ("PKD") and proposes methods of diagnosing the risk associated with aberrant purine metabolism alone, or in combination with hyperuricemia in patients most at risk for accelerated kidney disease progression. Recent discoveries at XORTX and by its independent research laboratories, suggests that certain individuals, most at risk for accelerated kidney disease progression, may be identified, diagnosed, and treated based upon a novel risk profile. This new patent application proposes proprietary diagnostic methods, and potential therapeutic approaches for personalizing the medicines used to treat those most at risk of health consequences of aberrant purine metabolism in cystic kidney diseases.

**About ADPKD**

Autosomal dominant polycystic kidney disease ("ADPKD") is a genetically linked nephropathy and the fourth most common cause of kidney failure requiring renal replacement therapy. Two genes are associated with ADPKD, PKD1 and PKD2, with mutation of PKD1 having a higher prevalence (85% of cases), an accelerated progression and more severe renal disease. Mutations are inherited in an autosomal dominant manner and display a vast spectrum of clinical disease severity depending on the inherited mutation and other factors, including age and sex.

ADPKD features bilateral growth of multiple renal cysts. The presence of cysts in the kidney leads to increased kidney volume that results in high blood pressure, decreased glomerular filtration rate ("GFR"), and ultimately renal failure. In ADPKD, hyperuricemia is reported to be prevalent and is an independent risk factor for progression, total kidney volume ("TKV"), endothelial dysfunction ("ED"), and more rapid decrease in GFR. There is evidence that hyperuricemia mediates ED and the rate of progression of ADPKD. Uric acid crystalluria has also been associated recently with cyst genesis and cyst expansion, similarly xanthine oxidase ("XO") enzyme expression in kidney tissue in two species of PKD suggest a tissue specific mechanism of injury unique to both tubule and cyst occurs in ADPKD. Because hyperuricemia is a modifiable risk factor, lowering and managing serum uric acid levels can decrease the rate of disease progression and maintain kidney health. In addition, intracellular inhibition of XO activity within the epithelial cells of both tubules and cysts in the kidney of individuals with progressing ADPKD tissue may optimally attenuate ADPKD disease progression and specifically slow increases in TKV and GFR decline. Therapeutic XO inhibition is anticipated to reduce the rate of decline of renal function in patients with ADPKD and hyperuricemia.

ADPKD is a rare disease that affects more that 10 million individuals worldwide.<sup>1,2</sup> ADPKD is typically diagnosed based upon expansion of fluid-filled cysts in the kidneys. Over time, the increasing number and size of cysts can contribute to structural and functional changes to kidneys and is frequently accompanied by chronic pain which is a common problem for patients with ADPKD.<sup>3</sup> Expansion of cysts is thought to compress healthy functioning tissue surrounding the cysts and contribute to further loss of kidney function, fibrosis, impaired nutrient exchange and impaired kidney function, accompanied later by end-stage renal disease.<sup>1</sup> For individuals with progressing ADPKD, treatment recommendations include anti-hypertensive treatment, dietary restrictions, and, for a limited percentage of suitable patients, pharmacotherapy.<sup>4</sup> New, more broadly applicable therapies to effectively slow decline of kidney function in ADPKD are needed.

**About XORTX Therapeutics Inc.**

XORTX is a pharmaceutical company with two clinically advanced products in development: 1) our lead, XRx-008 program for ADPKD; and 2) our secondary program in XRx-101 for acute kidney and other acute organ injury associated with Coronavirus / COVID-19 infection. In addition, XRx-225 is a pre-clinical stage program for Type 2 Diabetic Nephropathy. 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.

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| | |
|:---|:---|
| For more information, please contact: |  |
| Allen Davidoff, CEO | Nick Rigopulos, Director of Communications |
| adavidoff@xortx.com or +1 403 455 7727 | nick@alpineequityadv.com or +1 617 901 0785 |
| Media Inquiries, David Melamed, Ph.D. |  |
| david.melamed@russopartnersllc.com or +1 212 845 4225 |  |

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**References:**

* Wiley C., Kamat S., Stelhorn R., Blais J., Analysis of nationwide date to determine the incidence and diagnosis of autosomal dominant polycystic kidney disease in the USA, Kidney Disease, 5(2): 107-117, 2019

* Bergmann C., Guay-Woodford L.M., Harris P.C., Horie S., Peters D.J., Torres V.E., Polycystic Kidney Disease, Nat Rev Dis Primers. 4(1): 50, 2018

* https://pkdcure.org/living-with-pkd/chronic-pain-management/

* Gimpel C., Bermann C., Bockenhauer D., et al., International consensus statement of the diagnosis and management of autosomal dominant polycystic kidney disease in children and young people, Nat Rev Nephrol 15(11):713-726, 2019

*Neither the TSX Venture Exchange nor Nasdaq has approved or 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 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 under the heading "Risk Factors" in XORTX's Registration Statement on Form F-1 filed with the SEC, which is available on the SEC's website, www.sec.gov (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada, which are available on www.sedar.com.