On August 8, local time in the United States, Frontier Biotechnologies (Nanjing) Co., Ltd. (hereinafter referred to as the "Company", stock code: 688221. SH) announced the results of the Phase I clinical research of the small molecule drug FB2001 (common name: Bofutrelvir) at the 11th International Conference on Emerging Infectious Diseases (ICEID), a global academic conference in the field of infectious diseases.
FB2001 is a coronavirus 3CL protease inhibitor being developed by Frontier Biotechnologies. Its inhibitory activity IC of the coronavirus 3CL protease is 0.053±0.005 μM, and the above research results have been published in Science as a cover article. Studies have shown that FB2001 has significant antiviral activity against alpha, Beta, Delta and Omicron strains. The drug concentration of FB2001 monotherapy for injection in humans has reached the predicted effective dose without the need for a combination of pharmacokinetic enhancers (e.g. ritonavir), which reduces the risk of potential drug interactions.
Phase I clinical trial of FB2001 for injection, carried out in the United States and China, a total of 120 subjects received intravenous administration of FB2001, a single dose of 5 mg -400 mg / day, multiple doses of 30 mg -400 mg / day, continuous administration for 5 days. The results show that FB2001 has good clinical safety and tolerability, no dose-limiting toxicity (DLT), no serious adverse events have been reported, plasma drug concentrations and simulated lung drug concentrations can reach the effective drug concentration level of treatment, and pharmacokinetic characteristics are not different in the United States and Chinese populations. The Phase II/III clinical trial of FB2001 for Injection (BRIGHT Study) has been initiated to evaluate the efficacy and safety of FB2001 in hospitalized patients with COVID-19.
Dr. Jay Lalezari, MD, Medical Director of Quest Clinical Research in San Francisco said, "The results from the Phase 1 trial build on preclinical in vivo data of FB2001, where the drug was observed to reduce viral loads in both the lung and brain tissues of mice. Pharmacokinetic data obtained from preclinical studies showed significantly higher concentration of FB2001 in the lung compared to plasma. FB2001 has demonstrated in vivo antiviral activity in the lung and brain tissue of SARS-CoV-2 mouse model without the need for pharmacokinetic boosting. Therefore, it holds great promise as a treatment for acute COVID-19 as well as long-COVID, both of which will be evaluated in further follow-up studies".
Xie Dong, Chairman and Chief Scientific Officer (CSO) of Frontier Biotechnologies: "Most countries are recovering from the COVID-19 pandemic, but we must remember that the virus is not completely eradicated. The report on the new variant of the SARS-CoV-2 virus reminds us that not only vaccines need to be prepared, but also treatment plans.
Hu Min, Chief Medical Officer (CMO) of Frontier Biotechnologies: "The results of the Phase I trial are positive, we are accelerating the international multicentre phase II/III clinical trial of FB2001. It is expected to set up clinical centres in 30 countries, with more than 1,000 inpatients participating, to investigate the efficacy and role of FB2001 in shortening the recovery time of inpatients with coronavirus. We are confident to achieve a good result in the follow-up study.” Currently, the intravenous dosage of FB2001 is an ideal choice for inpatient patients, with rapid onset of action and suitable for patients with swallowing problems.
In addition, we are also conducting research on its inhalation formulation for post-exposure prophylaxis (PEP). We hope this may use in close contact populations who tested positive for COVID-19. This new formulation acts more rapidly and directly to suppress the virus and reduce systemic drug exposure when the drug is inhaled directly into the lungs through nebulization.”
Frontier Biotech new coronavirus treatment FB2001 Phase I clinical result video link:
https://tools.eventpower.com/exhibits/portal/preview_booth/22TFGH?exhibitor_id=XJAdzSlEpnw&hide_back=true