Brii Biosciences Announces Top-line Results from Phase 1 Study of BRII-296, A Long-Acting Therapy in Development for Postpartum Depression

Data demonstrated that a single administration of BRII-296 at 600 mg delivered a favorable pharmacokinetic profile and is safe and well-tolerated in healthy subjects Findings suggest BRII-296 has potential to provide a safe and effective, one-time injectable treatment option to people with PPD in an outpatient setting Company has identified an optimal dose regimen for BRII-296 for the upcoming Phase 2 study expected to commence by end of 2022 DURHAM, N.C., and BEIJING, China – September 22, 2022 – Brii Biosciences Limited (“Brii Bio” or the “Company”, stock code: 2137.HK), a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced top-line results from a Phase 1 study evaluating its long-acting, single-injection therapy, BRII-296, in development for the treatment of postpartum depression (PPD). These data show that a single treatment via intramuscular (IM) injection of 600 mg of BRII-296 achieved dose linearity, early drug absorption, gradual and extended release profiles without the need for dose titration or tapering, providing confidence that this dose has potential to achieve clinical efficacy in the treatment of PPD. The selected dose regimen will be evaluated in a Phase 2 clinical trial that is expected to begin this year. BRII-296 acts as a novel gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator (PAM) with a unique long-acting formulation that does not require cessation of breastfeeding and enables the drug to be effective for weeks after the patient leaves the injection appointment. It is designed to provide a rapid, profound and sustained reduction in depressive symptoms of PPD and may offer substantial clinically meaningful advantages over currently available treatment options for PPD. “We are encouraged by the possibility of providing a novel treatment option to the 900,000 people in the U.S. affected by postpartum depression each year in which the current standard of care is suboptimal, often requiring hospitalization, repeat therapy and daily doses of treatment,” said Ji Ma, Ph.D., Vice President of Preclinical Development and Clinical Pharmacology at Brii Bio, and lead author. “These data reinforce the potential for BRII-296 to redefine the PPD treatment landscape by providing a one-time, outpatient therapy that may effectively treat a range of depressive symptoms while maintaining a favorable safety and tolerability profile, including minimal exposure to breastfed infants.” “Initial results from this study are an important step forward as we continue to advance the development of BRII-296 in a robust and thoughtfully designed Phase 2 clinical study later this year that will incorporate fundamental patient experiences and preferences,” said Aleksandar Skuban, M.D., CNS Diseases Therapy Area Head of Brii Bio. “This comprehensive approach to development is critical in areas such as PPD where there are often considerable barriers to accessing care, in part because of wide-reaching social stigmas and a lack of disease awareness. This program reinforces Brii’s dedication to operating at the intersection of scientific innovation and patient insights in order to inform the full spectrum of strategic development in mental health conditions such as PPD as well as our broader global public health-inspired pipeline.” Data from healthy subjects in cohorts 1-15 were presented in a poster, titled Safety, Tolerability, and Pharmacokinetics of BRII-296, An Extended-Release Injectable Aqueous Suspension Formulation of Brexanolone in Healthy Adult Subjects , at the International Marcé Society Conference taking place in London, United Kingdom September 19-23, 2022. The full Phase 1 dataset will be presented at a scientific meeting later this year. About BRII-296 Phase 1 Trial The completed open-label, Phase 1, single ascending dose study assessed the safety, tolerability and PK of BRII-296 as a single-injection treatment option for PPD in 116 subjects enrolled across 16 cohorts. Three formulation concentrations (100 mg/mL, 200 mg/mL and 300 mg/mL) were administered via one or more IM injections to healthy adults at total dose levels of 30 mg, 75 mg, 100 mg, 200 mg, 300 mg and 600 mg. In addition, oral prophylactic treatment, or local steroid administration with BRII-296 (Depo Medrol via co-injection or admix) were evaluated to manage local injection site reactions (ISRs). The local steroid administration was shown in the study to effectively manage injection site reactions (ISRs). Of the 116 subjects, 98 subjects reported treatment emergent adverse events (TEAEs), with the majority considered drug-related and attributed to ISRs. Most ISRs were mild to moderate in severity and none lead to premature discontinuation from the study. There were no life threatening TEAEs, TEAEs leading to premature discontinuation of study, SAEs, or deaths. About Postpartum Depression Postpartum depression (PPD) is the most common psychological condition impacting people after giving birth. Affecting approximately 900,000 birthing people in the U.S. each year, including those who have miscarried or have had a stillbirth, PPD can present significant physical and mental health risks to the mother. In fact, suicide and overdose are the leading causes of death for childbearing people in the first year following pregnancy. Some healthcare providers believe the prevalence of PPD could be at least double, given unreported and untreated cases. PPD can also have negative effects on the maternal-infant relationship and it may lead to longer-term child development problems. Despite the prevalence and societal impact of PPD, currently approved treatment options remain limited and are associated with significant disruptions to daily life, including required hospitalization, repeat therapy and daily doses of treatment. About BRII-296 BRII-296 is a novel, single injection therapeutic candidate in development for the treatment and prevention of postpartum depression (PPD). It acts as a gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator (PAM) and is designed to provide a rapid, profound and sustained reduction in depressive symptoms of PPD with the potential to lead to greater adherence, convenience and fewer side effects compared to the current standard of care. BRII-296 will continue to be evaluated in an upcoming Phase 2 study for the treatment of PPD and is also in development for the prevention PPD. About Brii Bio Brii Biosciences Limited (“Brii Bio”, stock code: 2137.HK) is a biotechnology company based in China and the United States committed to advancing therapies for significant infectious diseases, such as hepatitis B, COVID-19, human immunodeficiency virus (HIV) infection, multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections, and other illnesses, such as the central nervous system (CNS) diseases, which have significant public health burdens in China and worldwide. For more information, visit www.briibio.com . Media Inquiry: [email protected] Darcie Robinson (U.S.) +1-203-919-7905 Investor Inquiry: [email protected] Previous Next [email protected] Home Company Back About Us Back Leadership Back Corporate Executive Team Back Board Of Directors Back Strategic Advisors Back Science Back Our Focus Pipeline Back Infectious Disease Programs Back Literature Archive Back Publications Back Conferences Back Media Back Press Release Back Brii Biosciences Announces Upcoming Conference Participation in November Brii Biosciences Presents Promising Clinical Data to Support Ongoing Development of Novel HIV Therapeutic Candidates at IDWeek 2022 Brii Biosciences to Present New Phase 1 Data from HIV Program at IDWeek 2022 Brii Biosciences Announces Top-line Results from Phase 1 Study of BRII-296, A Long-Acting Therapy in Development for Postpartum Depression Brii Biosciences Announces China Leadership Team Changes Brii Biosciences Appoints Taiyin Yang to Board of Directors, Strengthening Product Quality Oversight to Support Company Momentum Brii Biosciences Announces Upcoming Conference Participation in September Brii Biosciences Provides Corporate Update and Reports 2022 Interim Results WuXi Biologics Announced Exclusive Discovery Research with Brii Biosciences for Novel Bispecific Antibody Immunotherapeutics Brii Biosciences Builds Innovative Pipeline, Forges Public-Private Partnerships to Bring Novel Medicines to Chinese Patients FierceBiotech names Brii Biosciences as one of its “Fierce 15” Biotech Companies of 2018 Brii Biosciences Launches to Bring Innovative Medicines to Chinese Patients VBI Vaccines and Brii Biosciences Initiate Phase 1b/2a Study of BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B Infection Brii Biosciences Expands Infectious Disease Pipeline Brii Biosciences Expands Therapeutic Focus to Include Neurosciences with Addition of John Kraus, M.D., Ph.D. Brii Biosciences Provides Corporate Update on Progress Against Strategic R&D Priorities Brii Biosciences Appoints Rogers Luo, Ankang Li To Leadership Positions Tsinghua University, 3rd People’s Hospital of Shenzhen and Brii Biosciences Establish Partnership to Develop Neutralizing Antibodies Against COVID-19 Brii Biosciences Provides Funding to Columbia University for Research on COVID-19 and Other Coronaviruses Brii Biosciences Antibody Combination Will Not Progress into a Phase 3 Study Evaluating the Treatment of SARS-CoV-2 in Hospitalized Patients Brii Biosciences Closes US$155 Million Series C Financing Brii Biosciences, Vir Biotechnology, and VBI Vaccines Announce Initiation of Phase 2 Clinical Trial of BRII-835 (VIR-2218) in Combination with BRII-179 (VBI-2601) for the Treatment of Hepatitis B Brii Biosciences Monoclonal Antibodies, BRII-196 and BRII-198, Progress to Phase 3 in NIH ACTIV-2 Trial in Ambulatory COVID-19 Patients Brii Biosciences Provides Update on Strategic Clinical Development Progress Brii Biosciences to Present Updated Phase 1b/2a Data on BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B at the International Liver Congress 2021 Brii Biosciences and VBI Vaccines Present Positive Data from Completed Phase 1b/2a Study on BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B at the International Liver Congress 2021 Brii Biosciences Limited Successfully Listed on Main Board of Hong Kong Stock Exchange Brii Biosciences Initiates Phase 2 Clinical Trial in China for Neutralizing Antibodies, BRII-196 and BRII-198, in SARS-CoV-2 Brii Biosciences Announces the Completion of Enrollment in the Phase 3 National Institutes of Health (NIH) ACTIV-2 Trial, Evaluating the BRII-196 and BRII-198 Monoclonal Neutralizing Antibody Combination for the Treatment of COVID-19 Brii Biosciences Announces Positive Data from the Phase 3 ACTIV-2 Trial Evaluating Combination BRII-196 and BRII-198 in Non-Hospitalized COVID-19 Patients Brii Biosciences Adds US$100 Million to Advance its Late-Stage Monoclonal Antibody Combination Therapy, BRII-196/BRII-198, for Non-Hospitalized COVID-19 Patients Brii Bio Appoints Coy Stout as Senior Vice President and Head of U.S. Market Access and Patient Advocacy Brii Bio Initiates Submission of Emergency Use Authorization Filing to U.S. FDA for BRII-196/BRII-198, its Monoclonal Antibody Combination Therapy for Non-Hospitalized COVID-19 Patients at High Risk of Clinical Progression to Severe Disease Brii Bio Presents Positive Phase 3 Data on BRII-196/BRII-198, the Company’s SARS-CoV-2 Monoclonal Neutralizing Antibody Combination Therapy, in an Oral Late-Breaker Presentation at IDWeek 2021 Brii Biosciences Announces Upcoming Participation at November Conferences Brii Bio Receives the BioCentury-BayHelix R&D Achievement of the Year Award at the 2021 BioCentury China Healthcare Summit Brii Biosciences Joins Hang Seng Composite Index Brii Biosciences Included in Hong Kong Stock Connect Brii Bio Announces Amubarvimab/Romlusevimab Combination Received Approval from NMPA as First COVID-19 Neutralizing Antibody Combination Therapy in China Brii Biosciences Receives Clinical Hold Notification from US. FDA on BRII-732 Brii Bio Announces Amubarvimab/Romlusevimab Combination Retains Neutralizing Activity Against Omicron SARS-CoV-2 Variant Brii Bio Doses First Patient in Phase 2a/2b Clinical Trial of BRII-179 (VBI-2601) for the Functional Cure of Chronic Hepatitis B Brii Biosciences Appoints Eleanor de Groot as Chief Technology Officer and Aleksandar Skuban as Central Nervous System Diseases Therapy Area Head Brii Biosciences Announces Positive Data Demonstrating its Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, Retains Neutralizing Activity Against Live Omicron Virus BA.4/5 and BA.2.12.1 Subvariants Brii Bio Announces Strategic Partnership with China Resources Pharmaceutical Commercial Group to Advance the Commercialization of Long-acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, in China Brii Biosciences Appoints Dr. Susannah Cantrell as Chief Business Officer Brii Biosciences Announces Commercial Launch of its Amubarvimab/Romlusevimab Combination Therapy for COVID-19 in China Brii Biosciences Exercises Option for Vir Biotechnology’s VIR-3434, a Broadly Neutralizing Monoclonal Antibody Targeting Hepatitis B in Greater China Brii Biosciences Announces Upcoming Conference Participation in July Brii Biosciences Announces Positive Data from a Randomized, Single-Blind Study of its Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, in China Brii Bio Announces GMP Compliance Inspection Result for the Amubarvimab Injection and Romlusevimab Injection Brii Biosciences Announces Upcoming Conference Participation in June Brii Biosciences to be Added to MSCI China Small Cap Index Brii Bio Announces Positive Data Demonstrating its Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, Retains Neutralizing Activity Against Omicron BA.2 Subvariant Brii Bio Reports Progress on ESG Commitments in Its Inaugural ESG Report Brii Biosciences Announces Upcoming Participation at May Conference Brii Biosciences Announces Upcoming Participation at April Conferences Brii Bio Presents New Data on BRII-835 (VIR-2218) in Chinese Patients with Chronic Hepatitis B at APASL 2022 Brii Bio Announces Strategic Partnership with Sinopharm to Advance Commercialization of Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, in China Brii Biosciences Provides Corporate Update and Reports Full Year 2021 Financial Results Brii Bio to Present Phase 2 Data on Two Monthly Doses of BRII-835 (VIR-2218) in Chinese Patients with Chronic Hepatitis B at APASL 2022 Brii Bio Announces that National Health Commission of China Adds Amubarvimab/Romlusevimab Combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition) Brii Biosciences Announces Upcoming Participation at March Conferences Brii Bio Appoints Karen D. Neuendorff as Chief People Officer and Head of Human Resources Brii Biosciences Announces Upcoming Conference Participation in January Brii Biosciences Provides Update on Strategic Clinical Development Progress Brii Biosciences Announces Interim Results from Phase 2 Study Evaluating Combination BRII-835 and BRII-179 in Development for HBV Functional Cure Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Media Reports Back Investor Relations Back Fact Sheet Corporate Governance Back Board of Directors Back Committee Composition Back Corporate Governance Documents Back Listing Documents Back Announcements & Circulars Share Graph Financial Calendar Presentation & Webcast Back Webcasts Back Presentations Back Financial Reports IR Enquiries & Email Alert Replacement of Lost Share Certificates Back People Back Culture Benefits Back Meet Our Team Opportunities Contact Us © 2026 Brii Biosciences. All Rights Reserved. | Developed by Euroland IR Recruitment Scam Warning Privacy Statement Terms of Use This website uses cookies and similar technologies, to enhance your browsing experience and provide personalized recommendations. By continuing to use this website, you agree to the use of cookies and similar technologies as described in our Privacy Policy Accept

The release as fetched from its publisher. briibio.com ↗