XORTX Therapeutics, a company founded to focus on developing therapies to treat progressive kidney disease, has filed a pre-IND (Investigational New Drug) meeting request with the FDA. The company, based in Calgary, Alberta, filed pre-IND documents and secured a September 2018 meeting with the FDA to discuss development of its compound, XRx-008, for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The company currently plans to advance XRx-008 through phase 2 clinical trials.
Said XORTX’s CEO Allen Davidoff, MD: “We are excited to take this important first regulatory step in the development of the XRx-008 program for ADPKD. This request initiates the process of establishing communication and discussion with the FDA regarding our phase 2 clinical trial plans and defining the critical path for clinical development and marketing approval of this therapy for PKD patients.”
In 2018 the company has been advancing its two key programs: the ADPKD program and the diabetic nephropathy program through phase 2 proof-of-concept clinical trials.
The company’s stated aim is to identify and assess acquisition opportunities of companies that “have products for unmet needs and a higher than average probability of success.”
XORTX is continuing to partner with emerging and large pharma companies through opportunities to co-develop drugs and is in-licensing as a way to pursue corporate partnerships. In-licensing occurs when a company takes on some of the financial or technological work of developing a product, in return for a share of sales revenue.
Expanding its outlook in the renal community, XORTX has also paired with the Polycystic Kidney Disease Foundation to support patients, the company announced.