To date, the Company has successfully completed the research and development activities leading to this request and is advancing its XRx-008 program for the treatment of autosomal dominant polycystic kidney disease (“ADPKD”). R&D activities during the past year leading to this meeting request included manufacturing clinical quality GMP oxypurinol, finalizing formulation of drug product, and characterizing improved oral bio-availability of oxypurinol in animal models. The Company has achieved successful regulatory filings with the FDA and
The Pre-Phase 3 Briefing Package provides an up-to-date summary of the extensive work completed for the XRx-008 program and this type B meeting. In addition, the briefing package presents an agenda including topics and questions for discussion related to the critical developmental steps necessary to complete the planned clinical registration trial and for the marketing approval application.
Dr.
About Type B Meetings
Type B meetings are routine meetings that occur at pre-defined endpoints between the FDA and a sponsor. Meetings typically occur right after or right before the submission of clinical data or a new drug filing. Type B meetings can be for the following purposes:
- Pre-investigational 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)
About ADPKD
ADPKD is a rare disease that affects more that 10 million individuals worldwide.1,2 ADPKD is typically diagnosed based upon expansion of fluid-filled cysts in the kidneys. Over time, the increasing number and size of cysts can contribute to structural and functional changes to kidneys and is frequently accompanied by chronic pain which is a common problem for patients with ADPKD.3 Expansion of cysts is thought to compress healthy functioning tissue surrounding the cysts and contribute to further loss of kidney function, fibrosis, impaired nutrient exchange and impaired kidney function, accompanied later by end-stage renal disease.1 For individuals with progressing ADPKD, treatment recommendations include anti-hypertensive treatment, dietary restrictions, and, for a limited percentage of suitable patients, pharmacotherapy.4 New, more broadly applicable therapies to effectively slow decline of kidney function in patients with progressive kidney disease including those with ADPKD are needed.
About
XORTX is a pharmaceutical company with two clinically advanced products in development – XRx-008 for ADPKD, XRx-101 for acute kidney and other acute organ injury associated with Coronavirus / COVID-19 infection and XRx-225 is a pre-clinical stage program for Type 2 Diabetic Nephropathy (T2DN). 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 2 medications to improve the quality of life and future health of patients. Additional information on XORTX is available at www.xortx.com.
For further information, please contact:
adavidoff@xortx.com or +1 403 455 7727 | nick@alpineequityadv.com or +1 617 901 0785 |
The
References:
1. Wiley C., Kamat S., Stelhorn R., Blais J., Analysis of nationwide date to determine the incidence and diagnosis of autosomal dominant polycystic kidney disease in the
2. Bergmann C.,
3. https://pkdcure.org/living-with-pkd/chronic-pain-management/
4. Gimpel C., Bergmann C., Bockenhauer D., et al., International consensus statement of the diagnosis and management of autosomal dominant polycystic kidney disease in children and young people, Nat Rev Nephrol 15(11):713-726, 2019
Forward Looking Statements
This press release may contain express or implied forward-looking statements pursuant to Canadian and
Source:
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