Grand Pharmaceutical's Innovative Drug STC3141 Shows Promise in Treating Severe COVID-19, Completes European Phase IIa Trial

On January 18, Grand Pharma (512.HK) announced that the European Phase IIa clinical study of STC3141, a global innovative drug in development for severe infections, has completed dosing and follow-up for all enrolled patients with severe COVID-19. Preliminary data indicate favorable outcomes in terms of patient mortality and progression to severe disease, underscoring the product’s significant therapeutic potential for patients with severe COVID-19.

This European Phase IIa clinical trial of STC3141 aims to investigate and evaluate the safety, preliminary efficacy, and optimal dosing strategy of the drug in treating severe viral pneumonia caused by SARS-CoV-2 infection. The study enrolled a total of 25 patients, most of whom had multiple high-risk comorbidities such as diabetes, coronary heart disease, hypertension, and obesity. In addition to standard care, 10 patients received a low dose of the drug, 10 received a high dose, and 5 served as controls. Preliminary clinical data indicate favorable expected outcomes in terms of patient mortality and progression to critical illness.

It is understood that STC3141 is Grand Pharma’s global first-in-class drug. With an innovative mechanism of action, it reverses organ damage caused by excessive immune responses by neutralizing extracellular histones and neutrophil extracellular traps (NETs). The product is indicated for multiple critical conditions, such as sepsis and acute respiratory distress syndrome (ARDS), which are associated with high clinical mortality rates and lack effective therapeutic options. Preclinical research findings on this product were published in the prestigious academic journal Nature Communications in February 2020, demonstrating significant academic impact.

According to the latest data on the World Health Organization (WHO) website, as of 16:35 Central European Time on the 17th, the global number of confirmed COVID-19 cases reached 326 million. The United States continued to report more than 800,000 new confirmed cases in a single day, while France reported over 300,000 new daily cases. Meanwhile, multiple regions across China have recently reported infections with the Omicron variant, reigniting widespread public concern about COVID-19.

In fact, severe and critically ill patients hospitalized in the ICU due to COVID-19 are at a higher risk of progressing to viral sepsis, which complicates the treatment of severe COVID-19 cases. Statistical data have shown that sepsis is one of the causes of death attributable to the global COVID-19 pandemic. Furthermore, acute respiratory distress syndrome (ARDS), a common early complication in patients with sepsis, is also frequently observed in COVID-19 patients. As SARS-CoV-2 variants continue to spread across an increasing number of countries and regions worldwide, the development of novel therapeutics has become urgent. The favorable results from the European Phase IIa clinical trial of STC3141 demonstrate its significant potential in the treatment of severe COVID-19.

Grand Pharma stated that STC3141 is currently undergoing simultaneous clinical trials in multiple countries worldwide for diseases that pose significant threats to human health or lack effective treatments, including sepsis, acute respiratory distress syndrome (ARDS), and COVID-19. The company will actively advance the clinical development of STC3141 to further explore its potential in treating severe cases of COVID-19 and other indications.

It is reported that the field of critical care anti-infectives has long been one of Grand Pharma’s core strategic areas. The company stated that it will continue to vigorously advance the global synchronized development and related adaptive clinical trials of this product, while continuously strengthening its layout around three innovative strategic directions: “precision interventional diagnosis and treatment for cardiovascular and cerebrovascular diseases,” “interventional therapies, radiopharmaceuticals, and immunotherapies for oncology,” and “critical care anti-infectives.” These efforts aim to enhance the Group’s global innovative R&D capabilities and provide more advanced and diverse treatment options for patients worldwide.

As market attention refocuses, stocks related to COVID-19 have continued to surge in recent days. From the beginning of the year until the close on January 18, Ascletis Pharma (1672.HK) rose nearly 70% this month; Tuoxin Pharmaceutical (301089.SZ) gained over 50%; Andon Health (002432.SZ) increased by nearly 50%, having risen more than tenfold since last November; Orient Gene (688298.SH) climbed nearly 35%; and Simcere Pharmaceutical (2096.HK) saw a gain of over 20%.