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.