FDA Confirms Eligibility of XORLO™ for Accelerated Approval
04 Maio 2023 - 8:00AM
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, is pleased to announce completion of a positive and
constructive Type D meeting with the U.S. Food and Drug
Administration (“FDA”) which resulted in the identification of
additional clinical endpoints potentially available for accelerated
approval and further understanding of the FDA expectations for the
accelerated approval of XORLO™ for the treatment of autosomal
dominant polycystic kidney disease (“ADPKD”).
The FDA Type D meeting was conducted to discuss
with the agency the details of the accelerated approval process, a
clinical trial protocol for the XRX-OXY-301 study, and proposed
future clinical development program plans for XORLO™, XORTX’s
proprietary oxypurinol formulation, for the treatment of ADPKD. The
overall outcomes of the meeting included:
1/ Increased clarity regarding accelerated
approval endpoints that would qualify for a new drug application
(“NDA”), leading to marketing approval of XORLO™ for
ADPKD.
2/ Phase 3 clinical trial parameters such as
duration of treatment period required, follow up periods for
subjects recruited into the trial and preferred statistical
analysis methods, including the optimal information needed by the
FDA in their decision-making process.
3/ With this information in hand, XORTX will now
choose its primary clinical endpoint(s) and development strategy
based on ongoing discussions with prospective partners for the
asset.
4/ XORTX also intends to initiate and pursue a
Special Protocol Assessment (SPA) with the FDA for the XRX-OXY-301
program to further de-risk the development program for
XORLO™ for the treatment of ADPKD.
Dr. Allen Davidoff, CEO of XORTX, stated, “As a
result of this Type D meeting with the FDA, the Company is in a
much better position to advance and communicate the path to
accelerated approval. We now have the optimal information needed to
conduct the XRX-OXY-301 phase 3 clinical trial of XORLO™ to
treat individuals diagnosed with ADPKD. The combination of Orphan
Drug Designation granted April 21st and information from this Type
D meeting signifies key data for the phase 3 registration trial and
for ongoing partnering discussions.”
About XORLO™
XORLO™ is the working name of XORTX’
proprietary formulation of oxypurinol under development for the
treatment of individuals with progressing ADPKD. This and related
formulations are covered under granted US and European formulation
patents. Recent completion of a “bridging” Pharmacokinetics –
XRX-OXY-101, characterized key pharmacokinetics features of this
novel formulation, such as bioavailability, food effects, dose
proportionality and steady state PK parameters.
About XRX-OXY-301
The XRX-OXY-301 clinical trial is planned as a
Phase 3, Multi-Centre, Double-Blind, Placebo Controlled, Randomized
Withdrawal Design Study to Evaluate the Efficacy and Safety of a
Novel Oxypurinol Formulation in Patients with Progressing Stage 2-4
ADPKD and Coexistent Hyperuricemia. This clinical trial will
provide data to support future “Accelerated Approval" NDA
submissions to the FDA and European Medicines Agency (“EMA”). The
XRX-OXY-301 clinical trial is planned to start in the second half
of 2023 and will enroll individuals with stage 2, 3 or 4 ADPKD
accompanied by chronically high uric acid. The objective of the
clinical trial will be to evaluate the ability of XORLO™ to
slow the expansion of total kidney volume and/or slow glomerular
filtration rate decline over a 12-month treatment period. For more
information regarding the FDA’s Table of Surrogate Endpoints for
Drug Approval or License, please visit:
www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure
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 |
|
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Media Inquiries, David Melamed, Ph.D. |
|
david.melamed@russopartnersllc.com or +1 212 845 4225 |
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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.
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