Throughout 2023, the Company delivered significant milestones in its leading HBV program, driving the development of novel combination treatment regimens for an HBV functional cure while also expanding its portfolio. Following formative data readouts from ongoing trials with multiple HBV candidates and the acquisition of full intellectual property rights for BRII-179 and its technology transfer, Brii Bio is poised to launch multiple combination studies in 2024.
'2023 was a pivotal year for Brii Bio, with key insights received from multiple Phase 2 combination studies,' stated Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. 'Through vigorous clinical investigations over the past 5 years, we have a deep understanding of what is required to maximally reduce and sustain HBsAg loss. With BRII-179 we have a strategy to assess and enhance HBV patients' intrinsic immunity, targeting therapies to those most likely to respond, while sparing others from poorly tolerated regimens. These are important breakthroughs informing our late-stage clinical combination trials.'
Full Year 2023 and Recent Corporate Updates
In
BRII-179 received Breakthrough Therapy Designation (BTD) from the
Brii Bio secured exclusive development and commercialization rights for PreHevbriTM in
Brii Bio has prioritized resources to focus on the clinical and commercial development of its advanced HBV portfolio. The Company is actively seeking partnership opportunities for further development of its CNS, HIV, and MDR/XDR global assets.
Brii Bio has appointed Dr.
Full Year 2023 Core Clinical Pipeline Highlights and Upcoming Milestones
Hepatitis B Virus (HBV) Program
Key data were generated in 2023 confirming that BRII-179, our proprietary therapeutic vaccine, can trigger a potent and specific immune response in chronic Hepatitis B (CHB) patients and linking that response to improved clinical outcomes. Brii Bio, with our strategic partners, is conducting a series of confirmatory combination studies in 2024, to establish BRII-179 as a core component of future curative regimens in Hepatitis B. In furthering our commitment to BRII-179, Brii Bio negotiated full IP and manufacturing rights with VBI. We are working closely with our partners to initiate late-stage clinical studies to definitively address the contribution of BRII-179 and BRII-835 (elebsiran) towards achieving a higher functional cure rate of HBV infection. More importantly, BRII-179 holds the potential to identify immune-responsive CHB patients with a higher chance of achieving a functional cure.
Key Data and Development Plans: BRII-179 Related Studies and Plans
Brii Bio presented two late-breaking posters on BRII-179 at the American Association for the Study of Liver Diseases (AASLD)
BRII-179 induced functional immune responses that improve the rate and duration of HBsAg loss in CHB patients who receive PEG-IFN treatment, thereby increasing the CHB functional cure rate.
Translational research data from Brii Bio's Phase 1b/2a studies on BRII-179 and BRII-179 in combination with BRII-835 (elebsiran) suggests that BRII-179 may offer a unique opportunity to identify CHB patients who are able to elicit the necessary HBV-specific immune responses hence achieving higher functional cure rate in the selected patients while sparing others from unnecessary treatments.
Brii Bio plans to initiate additional combination studies in the second half of 2024 to confirm the ability of BRII-179 to enhance HBV functional cure rates in combination with other modalities.
Brii Bio will present data on patients meeting NRTI discontinuation criteria from its ongoing Phase 2 study of BRII-179 in combination with PEG-IFN in CHB patients as an oral late-breaking presentation at the 33rd Conference of
BRII-835 (Elebsiran) & BRII-877 (Tobevibart) Related Studies and Plans
Completed enrollment in the Phase 2 study of BRII-835 (elebsiran) in combination with PEG-IFN in the APAC region including mainland
Brii Bio's development partner,
In a late-breaker presentation at the AASLD The Liver Meeting in November 2023with an update at the 42nd Annual
A Phase 1 study of BRII-877 (tobevibart) is ongoing in
Additional Clinical and Pre-Clinical Development Updates
Based on the Company's strategy to focus on its advanced HBV programs, Brii Bio is pursuing partnership opportunities for the continued development of these programs.
Multidrug- and Extensively Drug-Resistant (MDR/XDR) Gram-Negative Bacteria Infections Program
BRII-693
Brii Bio gained exclusive global rights in
In
Human Immunodeficiency Virus (HIV) Infection Program
BRII-753 is an internally discovered new chemical entity currently in the preclinical stage of development. BRII-753 is being developed as a long-acting subcutaneous injection with the potential for dosing once monthly, once quarterly, or twice yearly and can be used in combination therapy for HIV treatment and as monotherapy for pre-exposure prophylaxis (PrEP).
BRII-732 has completed Phase 1 studies with the potential for development as part of an oral, once-weekly, long-acting combination treatment option for HIV patients.
Non-Tuberculous Mycobacterial (NTM) Lung Disease Program
BRII-658 (Epetraborole): In
Postpartum Depression (PPD) and Major Depressive Disorder (MDD)/Other CNS Disorders
BRII-296: In
BRII-297: Dosing has been completed in a Phase 1 clinical trial for BRII-297, a long-acting injectable (LAI) being developed to treat anxiety and depressive disorders. The study aims to evaluate the safety, tolerability, and PK of BRII-297 in healthy volunteers with data expected by the second half of 2024.
Full Year 2023 Financial Results
Our bank deposits and cash and cash equivalents were
Other income was
Research and development expenses were
Administrative expenses were
Total comprehensive expense for the year ended
About Brii Bio
Forward Looking Statement
The information communicated in this press release contains certain statements that are or may be forward looking. These statements typically contain words such as 'will,' 'expects,' 'believes,' 'plans' and 'anticipates,' and words of similar import. By their nature, forward looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company are unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
Contact:
Email: media@briibio.com
Email: ir@briibio.com
(C) 2024 Electronic News Publishing, source