Qx Therapeutics’ development compound QXT-101 has been granted fast-track designation by the U.S. FDA for the treatment of Pulmonary Graft Dysfunction (PGD) following Lung Transplantation.

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.

Qx Therapeutics Inc. has received FDA authorization of “Study May Proceed” with a Phase 2 Clinical Trial of QXT-101 for the prevention and treatment of PGD in lung transplant recipients.”

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.

Qx Therapeutics Inc. has received U.S. FDA authorization of “safe to proceed” with investigating QXT-101 in a Phase 2 Clinical Trial for Patients with Severe Symptomatic COVID-19 Infection.

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 Investigational New Drug application (IND) for investigating its lead investigational drug product, QXT-101, for a Phase 2 clinical trial of the safety and efficacy of QXT-101 in hospitalized patients with severe or critical coronavirus disease 2019 (COVID-19). Qx Therapeutics plans to initiate enrollment of patients as early as May 2021.

 

“This is a major milestone not only for the development of QXT-101 as a potential drug product but also for patients with COVID-19 infection, which is catastrophic in so many levels for the world”, said Xiaofeng Li, Ph.D., President and CEO of Qx Therapeutics Inc. “We hope that QXT-101 will provide a new treatment option for patients with COVID-19 infection based on the results of the clinical trial.” Added Ho Yin Lo, Ph.D. Chief Operating Officer of the company.

 

COVID-19 pandemic is caused by a novel coronavirus, designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  To date, there have been over 126 million worldwide cases with 2.7 million deaths. The virus can cause severe lung injury, which is a key contributing factor for hospitalization and fatality of COVID-19 patients. Currently available FDA approved treatment options include vaccines, antiviral and anti-inflammatory agents.  

 

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 coronavirus infection. The planned Phase 2 trial will focus on the safety and efficacy of QXT-101 in hospitalized patients with severe or critical coronavirus disease 2019 (COVID-19). 

 

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.

Small Business Innovation Research Program (SBIR) Phase 1 Grant

Qx Therapeutics Inc. has been awarded SMALL BUSINESS INNOVATION RESEARCH PROG (SBIR) Phase 1 grants of $269,641 by the NIH National Heart, Lung, and Blood Institute (NHLBI). This award will support the research and development work for lead project QXT-101 for the treatment of Acute Lung Injury (ALI) and Acute Respiratory Distress Symptoms (ARDS).

“We are very excited and feel privilege to have received this award by the NIH. This show the important of this project for the health of the people in America and the recognition of the direction we are taking to advance this drug candidate forward by the NIH.”
— Dr. Ho Yin Lo, Chief Operating Officer.

Pre-IND meeting with the Division of Transplant and Ophthalmology Products (DTOP)

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.”
— Dr. Ho Yin Lo, Chief Operating Officer