Qx Therapeutics Inc. has held a Pre-IND meeting with the Division of Transplant and Ophthalmology Products (DTOP) of FDA to discuss the IND application of the direct Phase 2a human clinical trial of QXT-101 for the treatment of Primary Graft Dysfunction (PGD) in surgical lung transplant patients. This Phase 2a trial will be mainly focus on the safety of the treatment to surgical patient (Primary End point) and the protective effect on acute lung injury result from the surgery (Secondary End Point).
During the meeting Qx Therapeutics team has received positive responses and comment from the FDA. The team will proceed with the remaining IND enabling studies according to the advice from the FDA and will project to submit the IND opening by January 2020.
“This was a very good first formal meeting with the DTOP of the agency. We believe that the FDA is very much at the same page with us on the development of QXT-101 toward clinical trial. There is an obvious urgency for a new treatment of Acute Lung Injury (ALI), an unmet medical needs, for patients and Qx Therapeutics has just taken a big step toward this goal.”