XORTX Commences Gout Program NDA Discussions with the FDA
XORTX Therapeutics (NASDAQ: XRTX) has submitted a Type C meeting request with the FDA regarding its XRx-026 program for gout treatment. The meeting aims to review the program's readiness for a New Drug Application (NDA) to gain marketing approval for XORLO™, the company's proprietary oxypurinol formulation, using the FDA's 505(b)2 development pathway.
The company has completed previously requested FDA work on oxypurinol and expects the meeting to be held within 75 days of the request. Management views this program as potentially revenue-positive within two years, targeting individuals with gout who have therapeutic options.
XORTX Therapeutics (NASDAQ: XRTX) ha presentato una richiesta di incontro di tipo C con la FDA riguardo al suo programma XRx-026 per il trattamento della gotta. L'incontro ha lo scopo di esaminare la prontezza del programma per una Nuova Richiesta di Farmaco (NDA) al fine di ottenere l'approvazione per la commercializzazione di XORLO™, la formulazione proprietaria di ossipurina dell'azienda, utilizzando il percorso di sviluppo 505(b)2 della FDA.
L'azienda ha completato i lavori precedentemente richiesti dalla FDA sull'ossipurina e si aspetta che l'incontro si tenga entro 75 giorni dalla richiesta. La direzione considera questo programma come potenzialmente positivo per i ricavi entro due anni, mirando a individui con gotta che hanno opzioni terapeutiche.
XORTX Therapeutics (NASDAQ: XRTX) ha presentado una solicitud de reunión de tipo C con la FDA respecto a su programa XRx-026 para el tratamiento de la gota. La reunión tiene como objetivo revisar la preparación del programa para una Nueva Solicitud de Medicamento (NDA) para obtener la aprobación de comercialización de XORLO™, la formulación propietaria de oxipurinol de la compañía, utilizando la vía de desarrollo 505(b)2 de la FDA.
La empresa ha completado el trabajo previamente solicitado por la FDA sobre el oxipurinol y espera que la reunión se realice dentro de los 75 días posteriores a la solicitud. La dirección considera que este programa podría ser positivo en términos de ingresos dentro de dos años, dirigido a personas con gota que tienen opciones terapéuticas.
XORTX Therapeutics (NASDAQ: XRTX)는 통풍 치료를 위한 XRx-026 프로그램과 관련하여 FDA에 타입 C 미팅 요청서를 제출했습니다. 이 미팅은 XORLO™의 마케팅 승인을 얻기 위한 새로운 의약품 신청(NDA)을 위한 프로그램 준비 상태를 검토하는 것을 목표로 합니다. 이는 회사의 독점적인 옥시퓨리놀 제형으로, FDA의 505(b)2 개발 경로를 사용하고 있습니다.
회사는 옥시퓨리놀에 대해 FDA가 이전에 요청한 작업을 완료했으며, 요청 후 75일 이내에 미팅이 개최될 것으로 예상하고 있습니다. 경영진은 이 프로그램이 두 년 이내에 수익성이 있을 것으로 보고 있으며, 치료 옵션이 있는 통풍 환자들을 대상으로 하고 있습니다.
XORTX Therapeutics (NASDAQ: XRTX) a soumis une demande de réunion de type C auprès de la FDA concernant son programme XRx-026 pour le traitement de la goutte. La réunion vise à examiner la préparation du programme pour une Demande de Nouveau Médicament (NDA) afin d'obtenir l'approbation commerciale de XORLO™, la formulation propriétaire d'oxypurinol de l'entreprise, en utilisant le chemin de développement 505(b)2 de la FDA.
L'entreprise a terminé les travaux précédemment demandés par la FDA sur l'oxypurinol et s'attend à ce que la réunion ait lieu dans les 75 jours suivant la demande. La direction considère ce programme comme potentiellement positif pour les revenus dans les deux ans, ciblant les personnes atteintes de goutte qui ont des options thérapeutiques.
XORTX Therapeutics (NASDAQ: XRTX) hat einen Antrag auf ein Typ-C-Meeting bei der FDA bezüglich seines XRx-026-Programms zur Behandlung von Gicht eingereicht. Ziel des Meetings ist es, die Bereitschaft des Programms für einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) zu überprüfen, um die Marktzulassung für XORLO™, die proprietäre Oxypurinol-Formulierung des Unternehmens, über den Entwicklungsweg 505(b)2 der FDA zu erhalten.
Das Unternehmen hat die zuvor von der FDA angeforderten Arbeiten zu Oxypurinol abgeschlossen und erwartet, dass das Meeting innerhalb von 75 Tagen nach dem Antrag stattfinden wird. Das Management sieht dieses Programm als potenziell umsatzpositiv innerhalb von zwei Jahren und richtet sich an Personen mit Gicht, die therapeutische Optionen haben.
- Company has completed all FDA-requested work on oxypurinol
- Program potentially revenue-positive within next two years
- Advancing towards NDA submission through 505(b)2 pathway
- FDA approval still pending and uncertain
- At least 75-day wait period before FDA meeting
Insights
This regulatory development marks a pivotal moment for XORTX Therapeutics' gout program. The Type C meeting request represents more than a routine regulatory checkpoint - it's a strategic acceleration of their path to commercialization. The 505(b)2 pathway they're pursuing is particularly significant as it can potentially reduce development time and costs by leveraging existing safety and efficacy data for oxypurinol, while protecting their proprietary formulation XORLO™.
The 75-day timeline to the FDA meeting is notably efficient, suggesting strong preparation and confidence in their data package. This accelerated timeline, combined with management's projection of potential revenue within two years, indicates a well-orchestrated regulatory strategy. For context, the gout therapeutics market faces significant unmet needs, with current treatments often showing efficacy or problematic side effects.
The company's focus on patients with therapeutic options is strategically sound. The gout therapeutics market is projected to expand significantly, driven by increasing prevalence and aging populations. XORTX's approach with XORLO™, particularly if it demonstrates superior efficacy or safety, could capture meaningful market share.
From an investor perspective, three key factors merit attention:
- The expedited 505(b)2 pathway could significantly reduce time-to-market compared to traditional NDAs
- The company has already completed previously requested FDA requirements, reducing regulatory uncertainty
- The two-year revenue timeline suggestion by management, while ambitious, aligns with the chosen regulatory strategy
However, investors should note that while this regulatory progress is positive, several critical phases remain before potential commercialization, including the actual Type C meeting outcome, NDA submission, and final FDA review.
● Type C Meeting Requested to Accelerate XRx-026 for Gout to NDA ●
CALGARY, Alberta, Feb. 24, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANUA), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease and gout, announces that it has submitted a Type C meeting request with the US Food and Drug Administration (the “FDA”) regarding the Company’s XRx-026 program for the treatment of gout. Development of XORLO™ 1, the Company’s proprietary drug formulation of oxypurinol, has advanced to the point where a Type C meeting and discussion with the FDA is warranted. The purpose of this meeting is to review the XRx-026 program and its readiness for submission of a New Drug Application (“NDA”) to gain marketing approval for XORLO™ in the US using the FDA’s 505(b)2 development pathway.
Dr. Allen Davidoff, XORTX’s CEO, commented, “The key elements of the XRx-026 program have advanced sufficiently to warrant a robust program review with the FDA. Having completed the work the FDA requested be conducted on oxypurinol in an approval letter issued previously, this Type C meeting will determine the FDA’s position prior to submitting a NDA for final marketing approval. The meeting is expected to be held within 75 days of the FDA’s receipt of the request. The prospect of helping individuals with gout that have otherwise few therapeutic options, combined with the fact that this program may be revenue positive within the next two years, is compelling.”
The Company will provide updates on the progress of the XRx-026 gout program when additional information is available.
About Gout
In the US, approximately 44 million individuals have circulating uric acid above the normal range(1) and approximately 9.2 million individuals have symptomatic gout. Gout is an inflammatory arthritis that is triggered by the crystallization of uric acid in tissues, particularly the joints. Gout flares cause severe pain, reduced quality of life(2), decreased physical function(2)(3), increased healthcare costs(4), and lost economic productivity(5). Furthermore, gout is strongly associated with other serious conditions such as myocardial infarction(6)(7), type 2 diabetes(8), chronic kidney disease(9), and premature mortality(6)(10)(11).
About the XRx-026 Program and XORLO™
The XRx-026 program is developing XORLO™ – a proprietary formulation of oxypurinol to treat individuals suffering from gout. At present, oral xanthine oxidase inhibitors (“XOIs”) are the preferred therapeutic option used to inhibit the production of uric acid and decrease high uric acid levels in gout patients. Allopurinol is the most commonly prescribed XOI, with approximately 3.3 million prescriptions written annually in the US. Although effective, 3 to
References:
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| (3) | Burke BT, Köttgen A, Law A, Windham BG, Segev D, Baer AN, et al. Physical Function, Hyperuricemia, and Gout in Older Adults. Arthritis Care Res. 2015 12;67(12):1730–8. |
| (4) | Rai SK, Burns LC, De Vera MA, Haji A, Giustini D, Choi HK. The economic burden of gout: A systematic review. Semin Arthritis Rheum. 2015 8;45(1):75–80. [PubMed: 25912932] |
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| (6) | Choi HK, Curhan G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation. 2007 8 21;116(8):894–900. [PubMed: 17698728] |
| (7) | Liu S-C, Xia L, Zhang J, Lu X-H, Hu D-K, Zhang H-T, et al. Gout and Risk of Myocardial Infarction: A Systematic Review and Meta-Analysis of Cohort Studies. Pizzi C, editor. PLOS ONE. 2015 7 31;10(7):e0134088. [PubMed: 26230580] |
| (8) | Choi HK, De Vera MA, Krishnan E. Gout and the risk of type 2 diabetes among men with a high cardiovascular risk profile. Rheumatology. 2008 8 13;47(10):1567–70. [PubMed: 18710901] |
| (9) | Roughley MJ, Belcher J, Mallen CD, Roddy E. Gout and risk of chronic kidney disease and nephrolithiasis: meta-analysis of observational studies. Arthritis Res Ther. 2015 12;17(1). |
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| (11) | Fisher MC, Rai SK, Lu N, Zhang Y, Choi HK. The unclosing premature mortality gap in gout: a general population-based study. Ann Rheum Dis. 2017 7;76(7):1289–94. [PubMed: 28122760] |
About XORTX Therapeutics Inc.
XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead program XRx-026 program for the treatment of gout; 2) XRx-008 program for ADPKD; and 3) XRx-101 for acute kidney and other acute organ injury associated with respiratory virus infections. In addition, the Company is developing XRx-225, a pre-clinical stage program for Type 2 diabetic nephropathy. XORTX is working to advance 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 that improve the quality of life and health of individuals with gout and other important diseases. Additional information on XORTX is available at www.xortx.com.
For more information, please contact:
| Allen Davidoff, CEO adavidoff@xortx.com or +1 403 455 7727 | Nick Rigopulos, Director of Communications 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 applicable securities laws. These forward-looking statements include, but are not limited to, the Company's beliefs, plans, goals, objectives, expectations, assumptions, estimates, intentions, future performance, other statements that are not historical facts and statements identified by words such as "expects", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or words of similar meaning. 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. Such risks, uncertainties, and other factors include, but are not limited to, our ability to obtain additional financing; the accuracy of our estimates regarding expenses, future revenues and capital requirements; the success and timing of our preclinical studies and clinical trials; the performance of third-party manufacturers and contract research organizations; our plans to develop and commercialize our product candidates; our plans to advance research in other kidney disease applications; and, our ability to obtain and maintain intellectual property protection for our product candidates. 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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1 XORLO™ is XORTX’s proprietary formulation of oxypurinol, that has granted US and EU patents.
2 Source: Takeda Pharmaceutical Company 2018 Annual Report.
FAQ
What is the timeline for XORTX's FDA Type C meeting for XRx-026 gout treatment?
When does XORTX expect revenue from its XORLO gout treatment program?
What regulatory pathway is XORTX pursuing for XORLO approval?
What is the purpose of XORTX's Type C meeting with the FDA?
