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 cleared the company’s initial Investigational New Drug application (IND) for investigating its lead investigational drug product, QXT-101. The trial protocol entitled, “A Phase 2, randomized, double-blind, multicenter, placebo-controlled, dose-escalation study to evaluate the safety and efficacy of QXT-101 for the prevention and treatment of primary graft dysfunction in lung transplant recipients.”

“Continuing the success of the IND’s “Safe-to-Proceed” in 2021 for investigating QXT-101 in COVID-19 patients, I congratulate our team for achieving another major milestone for investigating QXT-101 in another patient population with high unmet medical need”, said Xiaofeng Li, Ph.D., CEO of Qx Therapeutics Inc. ““Primary graft dysfunction (PGD) is such a significant trigger of acute and long-term complications for our lung transplant patients…we are excited to have the opportunity to advance such a promising treatment to clinical trial.”, said Todd Astor, M.D., M.B.A., Senior Advisor to Qx Therapeutics,  and renowned academic lung transplant pulmonologist.

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.

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.