Completion of first patient first visit in phase II clinical trial of TISA-818-Inj for the treatment of acute respiratory distress syndrome

Published on:

2023-12-26 11:32

The Phase II clinical trial of TISA-818-Inj for the treatment of acute respiratory distress syndrome (ARDS) recently completed first patient first visit (FPFV), which was led by Professor Zhan Qingyuan of the China-Japan Friendship Hospital and sponsored by EnliTISA (Shang Hai) Pharmaceutical Co., Ltd (Abbreviated as EnliTISA).

The multicenter, randomized, placebo-controlled phase II clinical trial aims to evaluate the safety, preliminary efficacy and pharmacokinetics of TISA-818-Inj in ARDS patients. Sixty moderate ARDS patients caused by pneumonia was planned and will be randomized into group 1, group 2 and placebo group in a ratio of 1:1:1.

ARDS is a highly heterogeneous and destructive disease. It is an acute diffuse inflammatory lung injury caused by multiple causes, which mainly include direct and indirect lung injury factors. The most common indirect lung injury factors are sepsis, pancreatitis, and trauma. Pneumonia and inhalation (such as gastric contents inhalation and smoke inhalation) are the most common direct lung injury factors.

The pathological and physiological characteristics of ARDS include damage to pulmonary capillary endothelial cells and alveolar epithelial cells, diffuse interstitial and alveolar edema, decreased lung volume, decreased lung compliance, and severe ventilation/blood flow imbalance. The imaging manifestations of its lungs are heterogeneous exudative lesions, with clinical manifestations of progressive hypoxemia and acute respiratory distress. At present, there is still a lack of single effective therapeutic drugs targeting the pathophysiology of ARDS, which is a challenge that this field will continue to face.

The class 1 innovative drug TISA-818 is independently developed by EnliTISA. Although TISA-818 has anti-inflammatory effects comparable to steroids, it does not exhibit immunosuppressive effects: it does not exhibit inhibitory effects on the activity of T cells and the secretion of inflammatory factors, nor does it delay the clearance of pathogens. It is expected that TISA-818 can be used for the treatment of infectious inflammation.

TISA-818-Inj is the first investigational drug that reach the stage of phase II, marking the beginning of the EnliTISA's exploration of clinical trials for the treatment of acute, chronic inflammation and fibrosis diseases.

Ms. Gu Ming, Chairman and General Manager of EnliTISA, commented, “The essence of innovative drug research and development is to meet the deepest unmet clinical needs. Currently, there is no effective drug for ARDS, and EnliTISA strives to develop anti-inflammatory drugs that do not have immunosuppressive properties and are expected to be used during the infection phase to meet clinical needs and achieve the dream of team entrepreneurship.”