XORTX Submits a New Patent for the Treatment of Chronic Kidney Disease
03 Janeiro 2024 - 9:00AM
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, announces submission of a new patent for the treatment of
chronic kidney disease (“CKD”). This patent is designed to protect
new discoveries and strategies for the treatment of individuals
with varied degrees of kidney function in the setting of CKD.
Importantly, this patent entitled “Oral and Sublingual Formulations
of Xanthine Oxidase Inhibitors and Methods of Treating Disease”
outlines new formulations and methods for safer and more effective
the use of xanthine oxidase inhibitors (XOI) in the setting of CKD
in particular autosomal dominant polycystic kidney disease (ADPKD),
diabetic nephropathy (DN), IgA nephropathy, lupus nephritis and
focal segmental glomerulosclerosis.
The positive topline results from the
XRX-OXY-101 bridging pharmacokinetic clinical study reported in Q1
2023 (the “Study”) characterized the pharmacokinetics of the
Company’s proprietary formulation of oral oxypurinol, XORLO™.
Results from the Study showed that XORLO™ was well tolerated
by the 88 subjects who received the drug. There were no safety
concerns during the testing of drug across the various dosing
regimens used. Overall results were positive and showed: i) a
substantial increase in the bioavailability of oxypurinol with the
XORLO™ formulation platform; (ii) a substantially increased
dose proportionality compared to non-formulated oxypurinol; (iii) a
multiple dosing regimen that achieved therapeutic target values. In
simple terms, substantially increased early oral absorption of
XORLO™, and increased circulating concentrations of oxypurinol
necessary to inhibit production of uric acid across the desired
therapeutic range and thereby slow down the advancements of CKD.
Each of these results will provide key data to facilitate precise
dosing recommendations for upcoming registration trials in
individuals with progressing kidney disease due to ADPKD as well as
other causes of CKD.
Dr. Allen Davidoff, CEO of XORTX, commented,
“The Bridging Pharmacokinetic Study reported this year provided a
wealth of clinical data regarding the potential substantive benefit
of the novel formulations of the xanthine inhibitor class of drugs.
Analysis of this data set, the use of in silico based
pharmacokinetic modeling of data from the XRX-OXY-101 clinical
trial, and further innovation, resulted in a deeper understanding
of how to address the challenges of dosing in progressing kidney
disease. This patent application is intended to claim new
opportunities to enhance how the xanthine oxidase inhibitor class
of drugs may be dosed in the future. Importantly, how to further
improve the safe and effective administration of this class of
drugs, including oxypurinol.”
About the XRx-008 program
Oxypurinol is a purine based XOI with important
pharmacologic characteristics ideal for administration to
individuals with ADPKD. Key pharmacologic attributes include:
1/ the ability to act in the circulation, kidney
and cardiovascular tissue and inhibit the production of uric acid
and so attenuate the mechanism of injury and accelerating effect of
XO on progressing diseases.
2/ XORTX’s proprietary formulation of
oxypurinol, XORLO™, provides substantially increased absorption of
oxypurinol. Metabolism of oxypurinol is minimal and it is
eliminated by the kidneys unchanged. This approach provides an
effective, well tolerated drug with an extensive clinical safety
experience suggesting the Company’s XRx-008 program has the
capacity to provide superior XOI to slow the accelerating decline
kidney function in patients ADPKD with coexistent
hyperuricemia.
About ADPKD
ADPKD is a rare disease that affects more that
10 million individuals worldwide.1,2 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.3 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.1 For individuals with progressing ADPKD, treatment
recommendations include anti-hypertensive treatment, dietary
restrictions, and, for a limited percentage of suitable patients,
pharmacotherapy.4 New, more broadly applicable therapies to
effectively slow decline of kidney function in ADPKD are
needed.
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
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
Respiratory Viral 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 with kidney disease. 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 TSXV 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
applicable securities laws, including those relating to future
sales of Shares under the ATM Offering, the offering price therefor
and the use of proceeds thereof. 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 applicable law and stock exchange
rules, 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 Annual Report on Form 20-F 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.
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