XORTX Announces Date of Pre-Phase 3 Meeting with US Food and
CALGARY, Alberta, Aug. 04, 2022 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on development of innovative therapies to treat progressive renal failure, is pleased to announce that the pre-Phase 3 meeting request to the United States Food and Drug Administration (“FDA”) has resulted in the granting of a virtual meeting scheduled for September 16, 2022 Prior to this meeting, XORTX submitted a “Pre-Phase 3 Information Package” to the FDA on Thursday, July 28, 2022.
To date, the Company has successfully completed the research and development activities leading to this application and is advancing its XRx-008 program for the treatment of autosomal dominant polycystic kidney disease (“ADPKD”). R&D activities over the past year that led to this meeting request included manufacturing of clinical-grade GMP oxypurinol, finalizing the drug product formulation, and characterizing the enhanced oral bioavailability of oxypurinol in animal models. The company has obtained regulatory filings from the FDA and Health Canada and has begun its OXY-XRX-101 bridging pharmacokinetic study. These important milestones have positioned XORTX well for this pre-Phase 3 meeting with the FDA.
The Pre-Phase 3 Briefing Pack provides an up-to-date summary of the in-depth work done for the XRx-008 program and this Type B meeting. In addition, the Briefing Pack presents an agenda including topics and discussion questions related to the critical development steps required to complete the planned clinical registration trial and for the marketing authorization application.
Dr. Allen Davidoff said, “We are excited to move the XRx-008 program forward with this dossier and set a meeting date with the FDA. We believe discussions with the FDA will clarify the optimal and key clinical steps needed before filing a New Drug Approval (NDA) in the United States for discussions with the FDA and moving the XRx program forward. -008.
About type B meetings
Type B meetings are routine meetings that take place at predefined endpoints between the FDA and a sponsor. Meetings usually take place right after or just before the submission of clinical data or the filing of a new drug. Type B meetings can have the following objectives:
- Pre-Investigation New Drug Application (Pre-IND) Meetings (21 CFR 312.82)
- Certain End of Phase 1 Meetings (21 CFR 312.82)
- End of Phase 2 and Pre-Phase 3 Meetings (21 CFR 312.47)
- Pre-New Drug Application/Biologics License Application Meetings (21 CFR 312.47)
ADPKD is a rare disease that affects more than 10 million people worldwide.1.2 ADPKD is usually diagnosed based on the expansion of fluid-filled cysts in the kidneys. Over time, the increasing number and size of cysts can contribute to structural and functional changes in the kidneys and are frequently accompanied by chronic pain, a common problem in patients with ADPKD.3 Cyst expansion is thought to compress healthy functional tissues surrounding the cysts and contribute to further loss of kidney function, fibrosis, impaired nutrient exchange, and impaired kidney function, accompanied later end-stage renal failure.1 For people with progressive ADPKD, treatment recommendations include antihypertensive therapy, dietary restrictions, and, for a limited percentage of appropriate patients, drug therapy.4 New, more widely applicable therapies to effectively slow the decline of renal function in patients with progressive renal failure, including those with ADPKD, are needed.
About XORTX Therapeutics Inc.
XORTX is a pharmaceutical company with two clinically advanced products in development – XRx-008 for ADPKD, XRx-101 for acute kidney injury and other acute organ injury associated with coronavirus/COVID-19 infection and XRx-225 is a program preclinical stage for type 2 diabetic nephropathy (T2D). XORTX strives to advance its products in clinical development that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit uric acid production. At XORTX, we are dedicated to the development of 2 drugs to improve the quality of life and future health of patients. Additional information about XORTX is available at www.xortx.com.
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1. Wiley C., Kamat S., Stelhorn R., Blais J., Analysis of national data to determine the incidence and diagnosis of autosomal dominant polycystic kidney disease in the United States, Kidney Disease, 5(2): 107 -117, 2019
2. Bergmann C., Guay-Woodford LM, Harris PC, Horie S., Peters DJ, Torres VE, polycystic kidney disease, Nat Rev Dis Primers. 4(1): 50, 2018
4. Gimpel C., Bergmann C., Bockenhauer D., et al., International consensus statement on the diagnosis and management of autosomal dominant polycystic kidney disease in children and young people, Nat Rev Nephrol 15(11): 713-726, 2019
This press release may contain express or implied forward-looking statements pursuant to Canadian and United States federal securities laws. These forward-looking statements and their implications are based solely on the current reasonable expectations of XORTX’s management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. . Except as otherwise required by law, XORTX undertakes no obligation to issue revisions or updates to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen events. More detailed information on the risks and uncertainties affecting XORTX is contained in the most recent annual information form filed by the company and in the management report for its last financial reporting period filed on the company’s SEDAR profile (www.sedar.com ) and under the heading “Risk Factors” in XORTX’s registration statement on Form F-1 filed with the Securities and Exchange Commission (“SEC”) available at the SEC’s website, www.sec. gov.