The group, represented by Professor Hideo Zhang of Tohoku University Graduate School, has completed the first phase II doctor-led clinical trial of TM5614, a drug that has the effect of improving blood clots, inflammation, and fibrosis.It has been confirmed that it is safe as a therapeutic agent to prevent the aggravation of pneumonia associated with the new coronavirus infection.In the future, the efficacy will be evaluated in late phase II clinical trials.Since it is an oral drug and easy to administer, it is expected to reduce the burden on patients and medical sites.
Approximately 80% of new coronavirus infections are mild, but pneumonia can become more severe in the elderly and patients with underlying illness, leading to lung injury and respiratory failure.In addition, even if it is mild at the beginning of the disease, it may rapidly become severe, and there are problems of thrombosis (complication) and pulmonary sequelae.In parallel with prevention by vaccination, it is desired to develop a therapeutic drug for preventing the aggravation of pneumonia.
TM1, a PAI-5614 inhibitor developed by Professor Toshio Miyata of Tohoku University, has the effect of promoting the dissolution of thrombi, improving lung inflammation and fibrosis, and reducing lung injury associated with the new coronavirus infection. Was also expected.Therefore, from October 2020, a total of 10 medical institutions, Tohoku University, Kyoto University, Tokyo Medical and Dental University, Tokai University, and Kobe City Medical Center General Hospital, will conduct a phase II doctor-led clinical trial. It was completed at the end of March 7 and its safety was confirmed.In addition, clinical trials of the drug are being conducted at university medical institutions in the United States and Turkey.
Furthermore, in order to evaluate the efficacy of TM5614, a late phase II doctor-led clinical trial will be conducted at 2021 medical institutions from May 5. A total of 20 patients with new coronavirus pneumonia (moderate) will be targeted, with 5614 clinical trials using TM50 tablets and placebo tablets. Since TM100 is an oral drug, it can be prescribed outpatiently and administered to patients undergoing medical treatment at home or at hotels, and is expected to reduce the burden on patients and medical sites.
