Dr.
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
April 21, 2023 – FDA granted Orphan Drug Designation for XRx-008 program for ADKPD, following review ofFebruary 1 st 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 theUS FDA .May 5, 2023 – FDA confirmed the eligibility of XORLO™ for Accelerated Approval following review ofMarch 14 th submission of type D meeting request withUS 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 atAmerican Society of Nephrology (“ASN”) under Session Title: “Genetic Diseases of the Kidneys”, by Dr.Charles Edelstein of theUniversity 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 ofXORTX 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 ofPathalys Pharma, Inc. , a private company specializing in advanced therapeutics for late-stage chronic kidney disease management.Mr. Treanor earned a BS in Management fromBryant University and an MBA fromRensselaer 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
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 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:
adavidoff@xortx.com or +1 403 455 7727 | nick@alpineequityadv.com or +1 617 901 0785 |
Neither the
Forward Looking Statements
This press release contains express or implied forward-looking statements pursuant to
Source:
2024 GlobeNewswire, Inc., source