- XORTX Therapeutics ( NASDAQ: XRTX ) said it had completed the previously announced Type B Pre-phase 3 meeting with the U.S. Food and Drug Administration for XRx-008 program for the treatment of autosomal dominant polycystic kidney disease.
- Ahead of the meeting with the FDA, the Pre-Phase 3 Briefing Package provided an up-to-date summary of the work completed for the XRx-008 program, including updates regarding chemistry, manufacturing, pharmacology, toxicology, clinical results to date, and regulatory and clinical plans.
- The company said the FDA reviewed the package of data and responded with minimal comments on the work accomplished to date and focused their feedback on XORTX clinical planning.
- The FDA's focus of the meeting was on optimizing trial design.
- "A particularly valuable aspect of FDA advice was an emphasis on how the Company might gain market approval with a single phase 3 registration trial to demonstrate efficacy and safety," the company added.
- XORT has risen 1.5% before the bell.
For further details see:
XORTX completes positive pre-phase 3 meeting with the FDA