Company received U.S. FDA clearance of Investigational New Drug Applications for four diverse pipeline candidates and advanced each into the clinic

Brii Biosciences (“Brii Bio”), a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burden, today provided an update on clinical development progress across its broad pipeline of investigational therapies. The Company has advanced eight therapeutic candidates across various stages of clinical development, addressing some of the world’s biggest public health issues and disease burdens in areas such as HIV infection, postpartum depression (PPD), multi-drug resistant (MDR) gram-negative bacterial infections, COVID-19 and hepatitis-B (HBV).

“In the five months since our last corporate update, we have made significant progress advancing clinical development of the various therapeutic candidates across our broad pipeline. In addition to ushering four new investigational therapies into clinical development, we recently announced continuation of BRII-196 and BRII-198 into a global Phase 3 trial for COVID-19, as well as progress in the BRII-835 and BRII-179 combination Phase 2 multi-regional clinical trial for chronic HBV infection,” said Zhi Hong, Ph.D., CEO of Brii Bio. “We look forward to building on this momentum as we advance our innovative programs through clinical development and continue to grow our company, tackling diseases that present major global public health challenges and acquiring promising clinical candidates through our existing collaborations.”

HIV Updates

• Under an approved U.S. Investigational New Drug Application (IND), Brii Bio has dosed subjects in the first cohort of its Phase 1 clinical trial evaluating BRII-732, a therapeutic designed for once-weekly oral dosing with potential to improve the quality of life of HIV-infected patients. Top-line results are expected in the first quarter of 2022.
• In March, the Company also initiated, under an approved U.S. IND, its Phase 1 clinical trial with BRII-778, another therapeutic designed for once-weekly oral dosing for HIV-infected patients. Top-line results are expected by the end of 2021.

Central Nervous System Disease (CNS) Updates

• Following approval of a U.S. IND, Brii Bio began dosing patients in April 2021 in its Phase 1 clinical trial with BRII-296 for the treatment of PPD.
• BRII-296 is being developed for PPD as well as major depressive disorder (MDD) and has potential to change the paradigm of patient care, helping to avoid hospitalization, preserve mother-infant bonding in PPD, and improve the safety and tolerability of current therapies. Top-line results are expected by the end of 2021.

Multi-drug Resistant (MDR) Gram-Negative Bacterial Infections Updates

• Brii Bio and its licensing partner, Qpex Biopharma (USA), are developing three products, two of which are based on the ultra-broad spectrum beta-lactamase inhibitor QPX7728, as part of the fixed combination products BRII-636 (OMNIvance®) IV and BRI-672 (ORAvance^TM) oral.
• Qpex recently initiated a Phase 1 study under an approved U.S. IND evaluating BRI-672 (ORAvance^TM), an oral ultra-broad-spectrum beta-lactamase inhibitor for the treatment of extended spectrum beta-lactamase (ESBL) and/or carbapenemase producing Enterobacteriaceae. Top-line results are expected in the first half of 2023.
• Qpex continues to develop BRII-636 (OMNIvance®) under an approved U.S. IND in a Phase 1 study of single and multiple ascending doses, which will include a cohort of first- or second-generation Chinese subjects in the second half of 2021. Top-line results are expected in the first half of 2022.
• Qpex is also proceeding with its planned Phase 1 study under an approved U.S. IND for BRII-693 (QPX-9003), a next generation synthetic polymyxin for the treatment of MDR infections caused by Pseudomonas aeruginosa and Acinetobacter baumannii. Dosing for this trial is planned to commence by the end of this quarter. Top-line results are expected in the first half of 2022.
• Brii Bio and Qpex previously entered into a strategic collaboration to develop and commercialize three of Qpex’s investigational products to treat a range of MDR gram-negative infections in Greater China. Under the terms of that agreement, Brii Bio obtained a license to develop, manufacture, and commercialize these products in Greater China, and Qpex retained all other rights globally.

SARS-CoV-2 Updates

• Brii Bio announced on April 29 that its monoclonal antibody combination therapy, BRII-196 and BRII-198, have been transitioned to Phase 3 of the ACTIV-2 trial in ambulatory COVID-19 patients with high risks for disease progression based on the recommendation of a Data Safety Monitoring Board composed of independent subject matter experts following a Phase 2 pre-specified analysis for safety and efficacy.
• The Phase 3 portion of the study, which has been actively enrolling participants, is expanding into international trial sites, allowing for a broader assessment of the BRII-196 and BRII-198 combination against emerging variants in ambulatory COVID-19 patients.

Hepatitis-B (HBV) Cure Updates

• Brii Bio, along with its licensing partners, Vir Biotechnology and VBI Vaccines, announced on April 21 that the first patient was dosed in a Phase 2 clinical trial evaluating BRII-835 (VIR-2218) in combination with BRII-179 (VBI-2601) for the treatment of chronic HBV infection.
• The multi-center, randomized, open-label study is designed to evaluate the safety and efficacy of BRII-835 compared to the combination of BRII-835 and BRII-179 with and without low dose interferon-alpha as a co-adjuvant and will be conducted at sites in Australia, China, Taiwan, Hong Kong Special Administrative Region of China, South Korea, New Zealand, Singapore, and Thailand.
• The Company has exclusive rights to develop and commercialize BRII-179 and BRII-835 in Greater China, while VBI and Vir have the exclusive rights to BRII-179 and BRII-835, respectively, in the rest of the world.

About Brii Biosciences

Brii Biosciences 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 and CNS diseases. For more information, visit www.briibio.com.

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