The United States and China Phase I clinical data appeared at the Global Academic Conference

On the evening of August 9, cutting -edge biological disclosure was the latest clinical data of FB2001, a small molecular molecular drug in the research. According to the clinical trial data of the United States and China, the FB2001 has good clinical safety and tolerance, no dose restriction to toxicity (DLT), and no serious adverse event reports have been seen.

The latest clinical data of the above, on August 8, 2022, on August 8, 2022, at the 11th International Conference of Infectious Diseases (Iceid). As a global academic conference, the first International Conference of Infectious Diseases (Iceid) in 1998 was successfully held in Atlanta, the United States, and the conference has held history for 24 years. This conference was jointly organized by scientific co -organizers from more than 30 different countries by the American Disease Control and Prevention Center (CDC), the American Infectious Diseases Association, the African Centers for Disease Control and Prevention, the American Microbiology Society, and the National Infectious Disease Foundation. On August 8th, it was successfully held in Atlanta in the United States. Experts from more than 1,500 public health from around the world attended the meeting, focusing on the problem of infectious diseases around the world, and conducted in -depth exchanges.

FB2001 is an anti -new coronal virus 3CL protease inhibitor developed by cutting -edge creatures. Its inhibitory activity IC for new coronary pneumonase 3CL protease is 0.053 ± 0.005 μm. The above research results have been published in the international authoritative journal "Science" (Science) and Published as a cover article. Studies have shown that FB2001 has significant antiviral activity on the new crown virus Alpha, Beta, Delta, and Omitron.

The announced FB2001 data shows that FB2001 shows excellent coronary anti -virus activity in vitro and internal body; the drug concentration of single drugs in the human body has reached the effective dose of prediction, and there is no need to combine pharmacokinetic enhancers (such as Lito Navavir ), Can reduce the risk of potential drug interaction; FB2001 can significantly reduce the virus load in the lungs and brain, and the reduction of brain virus load may have clinical significance for the sequelae of the central nervous system caused by new crown pneumonia.

Phase I clinical trials of FB2001 are carried out in the United States and China. A total of 120 subjects received intravenous injection of FB2001. The single dose is 5mg-400mg/day, and the multiple dose is 30 mg-400mg/day. The medicine is 5 days. According to the clinical trial data of the United States and China, the FB2001 has good clinical safety and tolerance, no dose restriction to toxicity (DLT), no serious adverse events report, plasma drug concentration and simulated lung drug concentration can reach The effective drug concentration level of treatment, pharmacokinetic characteristics are different in the United States and Chinese people.

In addition, the FB2001 Key II/III clinical trial (Bright Study) has been launched, which is designed to evaluate the effectiveness and safety of FB2001 among the new crown pneumonia hospitals. Anti -new coronary virus drug.

Regarding the results of the clinical IV research released by FB2001, Dr. Jay Lalezari, the director of clinical research and medical director of San Francisco, said that the results of the FB2001 III trials are based on preclinical research data. Observed that the drug can reduce mouse lung and brain tissue in mice and brain tissue Virus load. Pharmacokinetic data obtained from pre -clinical studies shows that the concentration of FB2001 in the lungs is significantly higher than that of plasma. FB2001 has shown an excellent body antiviral activity in the lungs and brains of the SARS-COV-2 mouse model, and does not need to use pharmacokinetic enhancers. Therefore, the FB2001 has great potential for the treatment of acute COVID-19 or long-term COVID. These two situations will be conducted in depth in subsequent research.

Dr. Xie Dong, chairman and chief scientist of cutting-edge biological biology, said that most countries in the world have recovered from the influence of COVID-19, but we must remember that humans still have not completely got rid of this virus. The announcement of the report of SARS-COV-2 virus new mutation strains reminds us not only to prepare the vaccine, but also the treatment plan. We are inspiring the main clinical results of FB2001, and we are confident in making positive results in subsequent research. Looking forward to the future, we hope that through continuous efforts, we can contribute to fight against COVID-19.

Dr. Wang Changjin, general manager of cutting -edge biological biology, said that the company is happy with the positive results of FB2001 I clinical clinical, which is an important milestone for us and the medical community, which will inspire us to work hard to promote subsequent clinical trials. We believe that our products and efforts will help the world's ability to improve the prevention and control of the new crown epidemic.

Regarding the subsequent clinical research of FB2001, Dr. Hu Min, chief medical officer of cutting -edge biology, said that the results of the stage I test are active. At presentMore than 1,000 inpatient patients participated to explore the effect and role of FB2001 in the rehabilitation time of the rehabilitation of new coronary pneumonia patients. We are confident to achieve a good result in subsequent research.At present, the venous injection type of FB2001 is a very ideal choice for inpatient patients. It has a rapid effect and is suitable for patients with difficulty swallowing or other swallowing problems.In addition, we are also conducting research on the exposure of the new crown detection of positive infection. When the drug is exposed, PEP can be used to directly inhale the lungs through atomization, which can inhibit the virus more quickly and directly, and reduce the amount of drug exposure of the whole body.Source: Volkswagen.com

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