Qx Therapeutics Inc., a pharmaceutical company focusing on novel treatments for lung injury and pulmonary diseases, announced today that the U.S. Food and Drug Administration (FDA) has designated as a Fast-Track development program for the investigation of QXT-101 for the treatment of Pulmonary Graft Dysfunction (PGD) following Lung Transplantation.
“Continuing the success of the IND’s “Study-May-Proceed” received earlier this year for the investigation of QXT-101 in Primary graft dysfunction (PGD), we are delighted to receive this good news for patients with PGD. This will expedite the clinical development of QXT-101 and ultimately shorten the time to bring this promising potential treatment to patients”, said Xiaofeng Li, CEO of QX Therapeutics.
PGD of the transplanted human lung is a form of acute lung injury (ALI) occurring after surgery. It is a major cause of early morbidity and mortality after lung transplantation and a potential risk factor for long-term post-transplant survival. Currently, there is no treatment for this condition, and it represents a highly unmet medical need.
Fast track is a process designed by the FDA to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
QXT-101 is a first in class treatment for patients who suffer from Acute Lung Injury (ALI). It is a fully licensed technology discovered at Yale University under Dr. Dianqing (Dan) Wu’s research laboratory. The mechanism of action (MOA) of QXT-101 involves the MAP3K2/3 pathway. In multiple animal proof of concept studies, this novel MOA is shown to be effective in treatment of ALI and ARDS upon different causes including reperfusion injury. The planned Phase 2 trial will focus on the safety and efficacy of QXT-101 for the prevention and treatment of primary graft dysfunction in lung transplant recipients.
About Qx Therapeutics Inc.
Qx Therapeutics Inc., a Yale University spinout, is a privately held U.S.-based pharmaceutical company founded in 2017. The company focuses on innovative approaches toward unmet medical needs in the pulmonary diseases and organ failure area. Qx Therapeutics Inc. was founded by top scientists, physicians, and key opinion leaders in the field of pulmonary diseases. It also has a seasoned management team that has a successful track record in life sciences companies. For more information, please visit www.qxtherapeutics.com.