- Initiated clinical research of investigational monoclonal antibodies BRII-196 and BRII-198 in combination for the treatment of COVID-19 in collaboration with the NIH-NIAID
- Continues to rapidly advance the development of potential therapeutics for the mitigation of serious infectious disease threats by HBV, multi-drug resistant gram-negative bacteria, and HIV
- Continues to advance CNS programs with IND for BRII-296 planned for January 2021
- Expanded U.S. Leadership Team with Executive Appointments
DURHAM, N.C., United States and BEIJING, China - 17 December 2020 – Brii Biosciences (“Brii Bio”), a multi-national company , today provided a corporate update on its research and development programs. The Company has advanced six therapeutic candidates addressing some of the world’s most significant infectious disease threats including COVID-19, hepatitis-B, and multi-drug resistant gram-negative bacterial infections.
“Brii Biosciences is committed to meeting the most urgent public health threats facing our society today by accelerating the development of medicines to prevent, treat and cure a range of infectious diseases including COVID-19, chronic hepatitis B, multi-drug resistant gram-negative bacterial infections, and HIV infection,” said Zhi Hong, Ph.D., CEO of Brii Bio. “The world urgently needs therapies to treat COVID-19 but the need extends far beyond today’s pandemic. We cannot ignore the fact that infectious diseases are a leading cause of death and disability worldwide with disruptive socioeconomic impact and we must be prepared for the inevitable public health challenges to come. Brii Bio is taking on this challenge with a focus on improving health and quality of life for people, no matter where they live.”
- BRII-196 and BRII-198 are non-competing SARS-CoV-2 neutralizing antibodies specifically engineered to reduce the risk of antibody-dependent enhancement. SARS-CoV-2 is the virus that causes COVID-19. The Company is working in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), to conduct Phase 2/3 trials of the Brii Bio antibody combination. This trial, part of the NIH’s ongoing COVID-19 Therapeutic Interventions and Vaccines (ACTIV-3) master protocol, will examine the clinical safety and efficacy of combination therapy with BRII-196 and BRII-198 in addition to standard of care in hospitalized patients with more severe COVID-19. This study (NCT04501978) commenced dosing in December 2020, and initial results are expected to be available early next year. Once the clinical findings are available, Brii Bio will work closely with regulatory agencies around the world to help ensure that the data are submitted for review to provide quick access for patients who may benefit from this treatment. Final preparations also are underway for studying the BRII-196 and BRII-198 combination in non-hospitalized COVID-19 patients who are at high risk of disease progression.
- The Company also submitted an Investigational New Drug (IND) application for the BRII-196 and BRII-198 combination to the Department of Health in Hong Kong in November 2020 and submitted a U.S. IND to the FDA for this study in December 2020. The clinical trial will investigate the clinical safety and efficacy in Asian populations with COVID-19 and is expected to begin in early 2021.
Hepatitis-B (HBV) Cure Updates
- Interim data from a Phase 1b/2a trial designed to assess the safety, tolerability and antiviral activity of BRII-179 (VBI-2601), a novel recombinant, protein-based immuno-therapeutic, demonstrated the induction of both antibody and T cell responses in chronically infected HBV patients.
- The Company announced that recruitment was completed for a Phase 2 clinical trial for BRII-835 (VIR-2218), a novel, investigational RNA interference (RNAi) therapeutic designed to inhibit expression of all HBV proteins, including hepatitis B surface antigen (HBsAg). Interim results are expected in the second quarter of 2021.
- During the first quarter of 2021, the Company is also preparing to launch a Phase 2 clinical trial examining the safety and efficacy of BRII-179 and BRII-835 in combination in patients who are on stable nucleos(t)ide therapies.
Multi-drug Resistant Gram-Negative Bacterial Infections Updates
Brii Bio is collaborating with Qpex Biopharma, Inc. to develop and commercialize in China a portfolio of novel antibiotics to treat infections caused by highly resistant, gram-negative pathogens.
- A Phase 1 clinical trial of BRII-636 (QPX-7728), a novel ultra-broad-spectrum beta-lactamase inhibitor, was initiated in November 2020 under a U.S. IND. This Phase 1 study will investigate the safety and pharmacokinetics of BRII-636 alone following single and multiple intravenous doses, and in combination with a beta-lactam antibiotic, in healthy adult subjects.
- A U.S. IND will be submitted for BRII-672, an oral ultra-broad-spectrum beta-lactamase inhibitor for the treatment of extended spectrum beta-lactamase (ESBL) and/or carbapenemase producing Enterobacteriaceae with a Phase 1 clinical study set to begin in March 2021.
- A U.S. IND application will be submitted for BRII-693 (QPX-9003), a next generation synthetic polymyxin for the treatment of multi-drug resistant infections caused by Pseudomonas aeruginosa and Acinetobacter baumannii and a Phase 1 clinical study is scheduled to start in March 2021.
- The Company is developing a new treatment option, a once weekly single tablet regimen for people living with HIV and plans to submit an IND in the U.S. for BRII-778 in January 2021. BRII-778 has the potential to be dosed orally once weekly.
- A U.S. IND for BRII-732, another molecule that has the potential to be dosed orally once weekly, is planned for January 2021.
- Phase 1 clinical trials for both BRII-778 and BRII-732 are expected to begin in February 2021.
Central Nervous System Disease (CNS) Updates
- The Company continues to advance its CNS programs forward with a focus on improving care for patients who suffer from major CNS diseases without effective therapies. The U.S. IND submission for BRII-296 is planned for January 2021. Brii Bio expects to begin Phase 1 clinical trials for BRII-296 in March 2021.
The Company also announced several executive appointments to help guide the Company’s continued growth in the United States.
- David Margolis, M.D., MPH, has joined Brii Bio as Vice President, Head of Infectious Diseases Therapy Area and is responsible for the Company’s clinical programs in infectious diseases in the U.S. Dr. Margolis also provides strategic input and support for clinical programs in China. He joined Brii Bio from GSK/ViiV Healthcare.
- Lijie Zhong, Ph.D., MBA, has joined the Company from Gilead Sciences as Vice President of Biometrics, Epidemiology and Real-world Evidence (RWE). In this role he leads the integrated team to apply efficient and validated approaches to study design, data collection, analysis and interpretation of clinical trials to achieve regulatory approval and marketing of new medicines.
- Lorraine Horgan has been promoted to Vice President, Program Management. Ms. Horgan joined the Company in August 2019 and has been responsible for establishing the program management function at Brii Bio. She has experience across multiple therapeutic areas including infectious diseases and has worked across multiple modalities. Ms. Horgan has a breadth of experience through all phases of drug development.
- Ji Ma, Ph.D., has been promoted to Vice President, Preclinical Development. Dr. Ma joined Brii Bio in June 2019 and has established the Company’s Drug Metabolism-Pharmacokinetics/Clinical Pharmacology function and has helped advance all programs from discovery stage to clinical stage. He has more than 20 years of drug discovery and development experience in multiple therapeutic modalities.
About Brii Biosciences
Brii Biosciences (Brii Bio) is a multi-national company committed to serving patients' needs and improving public health by accelerating the development and delivery of breakthrough medicines through partnerships, best-in-class research and development, and the disruptive application of digital and data insight. With operations in the People's Republic of China and the United States, Brii Bio is poised to serve as a bridge to carry transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the public health and wellbeing of patients around the world. Brii Bio is developing treatments for illnesses with significant public health burdens, including infectious diseases, liver diseases, and CNS diseases. For more information, visit www.briibio.com.