On Mar. 30, 2021, Qx Therapeutics announced that the FDA had 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 planned to initiate enrollment of patients as early as May 2021.

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).