XORTX Highlights Achievements of 2023 and Preparation for Registration Clinical Trial
19 Marzo 2024 - 3:00AM
XORTX Therapeutics Inc. ("
XORTX" or the
“
Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt:
ANUA WKN: A3UNZ), a late-stage clinical pharmaceutical company
focused on developing innovative therapies to treat progressive
kidney disease, is pleased to provide a summary of Company’s
achievements in 2023 and objectives planned for 2024.
Dr. Allen Davidoff, CEO of XORTX, stated, “2023
marked a year of substantial clinical, technological and regulatory
progress, establishing the foundation for the Company’s 2024 goals.
Key milestones include: 1/ the grant of U.S. Orphan Drug
Designation for the XRx-008 program for Autosomal Dominant
Polycystic Kidney Disease (“ADPKD”) that is being developed under
the US FDA 505(b)2 rules further de-risking this program; 2/
ongoing discussions with the US FDA have aligned our endpoints and
other Phase 3 clinical trial elements to make XORLO™ the
Company’s proprietary oxypurinol formulation, eligible for
accelerated approval. These key advances on the XRx-008 program
during 2023 were made possible by the exceptional efforts of our
Board of Directors, employees, consultants, and vendors. We believe
the goals set for 2024 will advance our lead program XRx-008 for
ADPKD ever closer to conducting a registration clinical trial
leading to marketing approval and value creation for XORTX and its
shareholders.”
In 2023, the Company made steady progress
advancing its strategic plan in key areas, including chemistry,
formulation, manufacturing, and non-clinical studies using
XORLO™ to attenuate polycystic kidney disease (“PKD”)
progression in animal models, and topline results from the
XRX-OXY-101 bridging clinical study of XORLO™. Each of these
milestones permit the next step in the Company’s clinical
development plan, being a “registration” clinical trial –
XRX-OXY-201 in pursuit of accelerated approval and support of the
Company’s lead program XRx-008 program for ADPKD.
Synopsis of 2023 Achievements
Chemistry and Manufacturing, Clinical
and Pre-Clinical Highlights – Produced
drug substance for oxypurinol production and produced GMP drug
substance; confirmed XORLO™ formulation, produced enhanced
bioavailability and produced clinical supply of tablets for
clinical trials.
Regulatory Submissions to US Food and
Drug Administration (“FDA”) and European Medicines Agency (“EMA”)
Supporting Clinical Trial Conduct
- April 21, 2023 – FDA granted Orphan
Drug Designation for XRx-008 program for ADKPD, following review of
February 1st submission of a comprehensive scientific review
package within an Orphan Drug Designation application for XRx-008
for treatment of progressing kidney disease due to ADPKD with the
US FDA.
- May 5, 2023 – FDA confirmed the
eligibility of XORLO™ for Accelerated Approval following
review of March 14th submission of type D meeting request with US
FDA to discuss the clinical development plan (XRX-OXY-201 clinical
trial design).
- August 29, 2023 – XORTX submitted
an Orphan Drug Designation application to the EMA for the treatment
of ADPKD. Following discussion and guidance from EMA, XORTX will
expand data package and resubmit to gain EMA Orphan Drug
Designation.
Technology and Patent
Advancements
- January 3, 2023 – XORTX submitted a
new Provisional Patent Application seeking broadened and lengthened
future patent protection, in a patent entitled “Compositions and
Methods for Diagnosis, Treatment and Prevention of Kidney
Disease.
- November 2, 2023 – XORTX sponsored
study results were presented at American Society of Nephrology
(“ASN”) under Session Title: “Genetic Diseases of the Kidneys”, by
Dr. Charles Edelstein of the University of Colorado. Results of
these studies suggest that management of xanthine oxidase activity
in PKD may be more important than previously appreciated and
further that previously unrecognized factors related to diet,
genetic factors or prescribed drugs that increase uric acid levels
could potentially aggravate the progression of PKD.
Organizational Highlights
- In addition to substantial
technological advancement, the Company continued to bolster the
XORTX team with the following appointments:
- June 26, 2023 - James Fairbairn was
appointed Chief Financial Officer of XORTX Therapeutics. Mr.
Fairbairn has more than 20 years of experience with publicly-traded
companies. He is a Chartered Professional Accountant, and an
Institute-certified Director.
- December 31, 2023 – Patrick Treanor
was appointed as a member of the XORTX Board of Directors. Patrick
Treanor is a seasoned pharmaceutical industry executive with over
25 years experience. He is the current Chief Operating Officer of
Pathalys Pharma, Inc., a private company specializing in advanced
therapeutics for late-stage chronic kidney disease
management. Mr. Treanor earned a BS in Management from
Bryant University and an MBA from Rensselaer Polytechnic
Institute.
- On November 29, 2023, XORTX
returned to NASDAQ compliance following a reverse split to increase
share price to greater than $1.00.
XRx-008 Program Highlights – Independent
Commercial Assessment
In support of ongoing pharmaceutical partnership
discussions, XORTX initiated an independent commercial assessment
of the XRx-008 program for ADPKD with Bluestar BioAdvisors. This
evaluation included interviews with 30 Nephrologists and 10
“Payers” with Large national Plans that cover greater than 290
million lives. Outcome of this assessment suggests that the XRx-008
program for ADPKD worldwide peak net sales per year that may exceed
$1B, with a total product life estimated to surpass 7 to 10
years.2024 Corporate Objectives
- March 4, 2024 – XORTX completed an
oversubscribed financing of $2.7 million.
- The Company will provide guidance,
in the near future, regarding 2024 Corporate Objectives including
announcements regarding clinical and regulatory submissions in
support of the XRX-OXY-201 clinical “registration” trial designed
to demonstrate the benefit of XORLO™ in slowing the
progression of declining filtering capacity in ADPKD.
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. 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 |
|
|
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.sedarplus.ca.
Xortx Therapeutics (TSXV:XRTX)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Xortx Therapeutics (TSXV:XRTX)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024