XORTX Announces Update for Discussion with the FDA
XORTX Therapeutics (NASDAQ: XRTX) has announced an upcoming Type B meeting with the FDA regarding their XRx-026 program for gout treatment. The company will submit a meeting package to the FDA within a week, with FDA communications expected by April 26, 2025.
The comprehensive review will cover chemistry, manufacturing, pharmacology, toxicology, and clinical evidence for XORLOTM, their proprietary oxypurinol drug formulation. The meeting aims to assess the program's readiness for a New Drug Application (NDA) through the FDA 505(b)2 development pathway.
The company believes this Type B meeting will facilitate broader discussions toward market approval, potentially transforming XORTX to a revenue-positive state by providing a new therapeutic option for gout patients.
XORTX Therapeutics (NASDAQ: XRTX) ha annunciato un prossimo incontro di Tipo B con la FDA riguardo al loro programma XRx-026 per il trattamento della gotta. L'azienda presenterà un pacchetto di documenti alla FDA entro una settimana, con comunicazioni da parte della FDA previste entro il 26 aprile 2025.
La revisione completa coprirà chimica, produzione, farmacologia, tossicologia e prove cliniche per XORLOTM, la loro formulazione proprietaria di ossipurinale. L'incontro ha l'obiettivo di valutare la prontezza del programma per una Domanda di Nuovo Farmaco (NDA) attraverso il percorso di sviluppo FDA 505(b)2.
L'azienda crede che questo incontro di Tipo B faciliterà discussioni più ampie verso l'approvazione sul mercato, trasformando potenzialmente XORTX in uno stato positivo di entrate, offrendo una nuova opzione terapeutica per i pazienti affetti da gotta.
XORTX Therapeutics (NASDAQ: XRTX) ha anunciado una próxima reunión de Tipo B con la FDA respecto a su programa XRx-026 para el tratamiento de la gota. La empresa enviará un paquete de reunión a la FDA dentro de una semana, con comunicaciones de la FDA esperadas para el 26 de abril de 2025.
La revisión integral abarcará química, fabricación, farmacología, toxicología y evidencia clínica para XORLOTM, su formulación de fármaco de oxipurina patentada. La reunión tiene como objetivo evaluar la preparación del programa para una Solicitud de Nuevo Medicamento (NDA) a través de la vía de desarrollo FDA 505(b)2.
La empresa cree que esta reunión de Tipo B facilitará discusiones más amplias hacia la aprobación en el mercado, transformando potencialmente a XORTX en un estado positivo de ingresos al proporcionar una nueva opción terapéutica para los pacientes con gota.
XORTX Therapeutics (NASDAQ: XRTX)는 통풍 치료를 위한 XRx-026 프로그램과 관련하여 FDA와의 다가오는 B형 회의를 발표했습니다. 이 회사는 일주일 이내에 FDA에 회의 패키지를 제출할 예정이며, FDA의 통신은 2025년 4월 26일까지 예상됩니다.
종합적인 검토는 XORLOTM, 그들의 독점 옥시퓨리놀 약물 제형에 대한 화학, 제조, 약리학, 독성학 및 임상 증거를 포함할 것입니다. 이 회의의 목표는 FDA 505(b)2 개발 경로를 통해 신약 신청(NDA)에 대한 프로그램의 준비 상태를 평가하는 것입니다.
회사는 이 B형 회의가 시장 승인에 대한 보다 폭넓은 논의를 촉진할 것이라고 믿고 있으며, 이는 통풍 환자에게 새로운 치료 옵션을 제공함으로써 XORTX를 수익 긍정적인 상태로 전환할 수 있습니다.
XORTX Therapeutics (NASDAQ: XRTX) a annoncé une prochaine réunion de type B avec la FDA concernant leur programme XRx-026 pour le traitement de la goutte. L'entreprise soumettra un dossier de réunion à la FDA dans une semaine, avec des communications de la FDA attendues d'ici le 26 avril 2025.
La révision complète couvrira la chimie, la fabrication, la pharmacologie, la toxicologie et les preuves cliniques pour XORLOTM, leur formulation de médicament à base d'oxypurinol. La réunion vise à évaluer la préparation du programme pour une Demande de Nouveau Médicament (NDA) via le chemin de développement FDA 505(b)2.
L'entreprise estime que cette réunion de type B facilitera des discussions plus larges en vue d'une approbation sur le marché, transformant potentiellement XORTX en un état positif de revenus en offrant une nouvelle option thérapeutique pour les patients atteints de goutte.
XORTX Therapeutics (NASDAQ: XRTX) hat ein bevorstehendes Typ-B-Meeting mit der FDA zu ihrem XRx-026-Programm zur Behandlung von Gicht angekündigt. Das Unternehmen wird innerhalb einer Woche ein Meeting-Paket bei der FDA einreichen, wobei mit Mitteilungen der FDA bis zum 26. April 2025 gerechnet wird.
Die umfassende Überprüfung wird Chemie, Herstellung, Pharmakologie, Toxikologie und klinische Evidenz für XORLOTM, ihre proprietäre Oxypurinol-Arzneiformulierung, abdecken. Das Meeting zielt darauf ab, die Bereitschaft des Programms für einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) über den Entwicklungsweg FDA 505(b)2 zu bewerten.
Das Unternehmen ist der Ansicht, dass dieses Typ-B-Meeting breitere Diskussionen über die Marktzulassung erleichtern wird, was XORTX potenziell in einen umsatzpositiven Zustand verwandeln könnte, indem es eine neue therapeutische Option für Gichtpatienten bietet.
- Advancing toward potential NDA submission for gout treatment
- FDA engagement through Type B meeting indicates program progression
- Potential transformation to revenue-positive status upon approval
- Additional information may be required by FDA before NDA submission
- Timeline for potential market approval remains uncertain
- No guarantee of FDA approval despite meeting progression
Insights
XORTX's FDA update signals meaningful advancement in their regulatory strategy for XRx-026, their gout treatment candidate. The FDA has requested a Type B meeting to review comprehensive aspects of the program including chemistry, manufacturing, pharmacology, toxicology, and clinical evidence. This meeting format typically indicates the FDA's willingness to provide substantive guidance on a development program approaching potential NDA submission.
The company will pursue the 505(b)2 pathway, which can significantly streamline the approval process by leveraging existing data on oxypurinol, potentially reducing development time and costs. This pathway is particularly valuable for reformulations of previously approved active ingredients.
What's noteworthy is the breadth of the requested review, suggesting the FDA sees merit in evaluating the program's readiness for marketing application. For a microcap biotech with
The announcement doesn't contain specific clinical efficacy data but indicates leadership believes their proprietary XORLO™ formulation has advanced sufficiently for potential marketing approval consideration. For gout patients, new treatment options remain an unmet need despite existing therapies, suggesting a viable market opportunity if approved.
● Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA ●
CALGARY, Alberta, March 19, 2025 (GLOBE NEWSWIRE) -- 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 and gout, is pleased to provide an update regarding communications with the US Food and Drug Administration (the “FDA”). At the request of the FDA a type B meeting package will be provided by the Company during the next week, and accompanying FDA communications are expected by April 26, 2025. The Company has prepared a broad Type B meeting review at the request of the FDA, including review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence regarding the Company’s XRx-026 program for the treatment of gout. Drug Development of XORLOTM, the Company’s proprietary drug formulation of oxypurinol, has advanced substantially to a state where a Type B meeting and discussion with the FDA to confirm the developmental state of each element of the program is warranted. The purpose of this meeting will be to review the XRx-026 program and its readiness for submission of a New Drug Application (“NDA”) to gain marketing approval for XORLOTM in the US using the FDA 505(b)2 development pathway. The Company believes that a Type B meeting will facilitate a broader discussion toward market approval.
Dr. Allen Davidoff, CEO of XORTX commented, “We look forward to FDA feedback the last week in April and advancing the XRx-026 program, thereafter. Many key elements of the XRx-026 program have advanced sufficiently to warrant this robust program review with the FDA to define any additional information needed to complete this marketing approval. We believe that the XRx-026 program provides a much needed therapeutic option for individuals with gout and that advancing with the XRx-026 program will transform XORTX to a revenue positive state.”
The Company will provide further updates following communications with the FDA when additional information is available.
About Hyperuricemia and Gout
In the US it is estimated that approximately 44 million individuals have circulating uric acid above the normal range(1). The prevalence of gout was
About the XRx-026 Program and XORLOTM
The XRx-026 program is developing XORLOTM, 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 chronically high uric acid in the circulation. Allopurinol is the most commonly prescribed XOI, with approximately 3.3 million prescriptions written per year in North America, however 3 to
About Type B Meetings with the FDA
Type B meetings for each potential application (e.g., investigational new drug application (IND), NDA, biologics license application (BLA)) or combination of closely related products developed by the same sponsor or applicant (e.g., same active ingredient but different dosage forms being developed concurrently). Typically, it may be appropriate to conduct more than one of some of the Type B meetings for concurrent development of a product for unrelated claims.
References:
(1) Chen-Xu M_Prevalence of Gout and Hyperuricemia in the US_ArthritisRheumatol_71-6_991-999_2019_nihms-1002533
(2) Singh JA. Quality of life and quality of care for patients with gout. Curr Rheumatol Rep. 2009 4;11(2):154–60. [PubMed: 19296889]
(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]
(5) Choi HK, Ford ES. Prevalence of the metabolic syndrome in individuals with hyperuricemia. Am J Med. 2007 5;120(5):442–7. [PubMed: 17466656]
(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).
(10) Kuo C-F, See L-C, Luo S-F, Ko Y-S, Lin Y-S, Hwang J-S, et al. Gout: an independent risk factor for all-cause and cardiovascular mortality. Rheumatology. 2010 1;49(1):141–6. [PubMed: 19933595]
(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.
FAQ
When will the FDA provide feedback on XORTX's XRx-026 gout treatment program?
What regulatory pathway is XORTX pursuing for XORLOTM gout treatment approval?
What aspects will be reviewed in XORTX's Type B meeting with the FDA?
What is the purpose of XORTX's Type B meeting with the FDA for XRx-026?
