Xortx Therapeutics provides update on FDA Type B meeting request

XORTX Therapeutics (XRTX) has received responses from the US Food and Drug Administration and clarified key steps for a new drug application for the Company’s novel proprietary formulation of oxypurinol for the treatment of gout. The Type B meeting conducted by the FDA, included review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence to support the Company’s XRx-026 program for the treatment of gout. Responses from the FDA substantially confirmed and clarified the remaining key steps necessary prior to filing a NDA to gain marketing approval for XORLO in the US using the FDA 505(b)2 development pathway. With this FDA guidance, XORTX will now advance the following key steps to support the NDA application and its submission for the XRx-026 program for gout. Finalize meeting minutes with the FDA regarding the agency and XORTX’s responses; Prepare and file an Investigative New Drug application for the XRx-026 program; Characterize pharmacokinetics of the commercial tablet formulation of XORLO in absence and in the presence of food; Manufacture, validate commercial supplies of drug accompanied by stability data in parallel with the NDA preparation; and Prepare and file a NDA for marketing approval of XORLO.