Shots:
- Changjin spoke about the P-I results of their lead candidate, Bofutrelvir to treat acute and long covid. The data was presented at the poster session of the 11th International Conference on ICEID, 2022
- Changjin also talked about the upcoming formulations of this innovative medicine and the initiation of its BRIGHT study covering the P-II/III trial of Bofutrelvir
- The interview summarizes Frontier Biotech’s vision to develop and commercialize innovative therapeutic products to improve patients’ health
Smriti: Discuss your prime product for Covid-19, bofutrelvir (its MOA, ROA, formulation, pathway, etc.)
Changjin: Bofutrelvir or FB2001 is a Coronavirus Mpro (aka 3CL protease) inhibitor, which exhibited potent anti-SARS-CoV-2 activity in vitro and in vivo. It significantly reduces coronavirus viral load in the lungs and brain of a murine model, the latter of which may have clinical implications for the sequelae of the central nervous system of COVID-19. FB2001 is the first anti-COVID-19 drug to report antiviral activity in the brain.
Smriti: Shed some light on the P-I clinical trial results of bofutrelvir.
Changjin: Phase 1 results showed bofutrelvir to be generally safe and well tolerated. No significant difference was observed between the Chinese and American populations enrolled in the study. Single-agent antiviral concentrations have been reached in the blood plasma and lung tissues of test subjects without the need for pharmacokinetic enhancers, thus potentially minimizing the risk of drug interactions.
Smriti: When do you plan for further studies and when are the results expected?
Changjin: The BRIGHT (Bofutrelvir in Global Hospitalized Patients) study, a Phase 2/3 trial that explores the utility of bofutrelvir in reducing the time to recovery in patients hospitalized due to COVID-19 has begun. Interim results are expected by the end of the year or the beginning of next year.
Smriti: As the drug has currently taken in IV formulation, are you planning for its development in other formulations as well?
Changjin: We are developing a pulmonary formulation of bofutrelvir that could be used in outpatient settings for the treatment of mild COVID-19, as well as for post-exposure prophylaxis. When inhaled directly into the respiratory tract and lungs, the tissue concentration of FB2001 is much higher than that in plasma; hence the onset of action and viral clearance could potentially be faster than that of oral therapy.
Smriti: Tell us how Bofutrelvir will reduce the recovery time in patients.
Changjin: Bofutrelvir is a potent 3CL protease (a clinically validated target for SARS-Cov-2) inhibitor that has shown broad antiviral activities in vitro and in vivo for Alpha, Beta, Delta, and Omicron variants. Phase 1 clinical data shown that it is safe and tolerable, and the predicted effective dose has been reached without the use of a pharmacokinetic ‘booster’. This single-agent treatment reduces the risk of drug-drug interactions in hospitalized patients who may have to use many medicines at the same time.
Smriti: Please brief us on how this innovative medicine would be different from the other treatment options available in the industry.
Changjin: Currently, only one 3CL protease inhibitor (ie, nirmatrelvir/ritonavir combination therapy) is available and it is an oral tablet indicated for outpatient use. Based on the explanation given above, we aim to develop an intravenously administered formulation of bofutrelvir, which is ideal for hospitalized patients.
Smriti: What are the upcoming products in your pipeline?
Changjin: We have a number of products that are currently in our drug development pipeline:
- In the HIV space, we have FB1002 combination drug (albuvirtide + 3BNC117) that is undergoing three Phase II trials in the United States and China.
- For COVID-19, we have FB2001 which is currently undergoing Phase II and III clinical trials globally.
- We also have FB3001, a novel topical patch for the management of pain and inflammation that is about to enter a Phase III trial.
- FB6001, a therapeutic peptide vaccine targeting PCSK9, is an anti-hypercholesterolemia / low-density lipoprotein agent, currently in preclinical development.
As a company, we are constantly leveraging our expertise and experience to discover and develop new drugs that help ease patients’ disease burden. We are aiming to grow our presence globally, with the hope of attracting new talents and taking our capabilities to the next level.
Source: Canva
About the Author:
Dr. Changjin Wang is the CEO and a board member of Frontier Biotechnologies Inc. Dr. Wang began his career in the pharmaceutical industry as a research scientist and has 30+ years of experience in the pharmaceutical and biotech industries in China and the US. Dr. Wang earned his Bachelor of Medicine and Master of Medicinal Chemistry from the Huaxi University of Medical Sciences and Ph.D. of Pharmaceutical Sciences from the College of Pharmacy, University of Kentucky.
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