{"id":41402,"date":"2025-11-07T13:30:00","date_gmt":"2025-11-07T13:30:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4818543_AE18543_0"},"modified":"2025-11-07T13:30:00","modified_gmt":"2025-11-07T13:30:00","slug":"brii-biosciences-announces-publication-of-phase-2-ensure-study-results-in-nature-medicine","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=41402","title":{"rendered":"Brii Biosciences Announces Publication of Phase 2 ENSURE Study Results in Nature Medicine"},"content":{"rendered":"<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1690538\/Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><i>Findings provide scientific insights into the contribution of small interfering RNA (siRNA) and therapeutic vaccination towards the HBV functional cure strategy<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">DURHAM, N.C.<\/span> and <span class=\"xn-location\">BEIJING<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Nov. 7, 2025<\/span><\/span> \/PRNewswire\/ &#8212; <a href=\"https:\/\/www.briibio.com\/\" target=\"_blank\" rel=\"nofollow noopener\">Brii Biosciences Limited<\/a> (&#8220;<span class=\"xn-person\">Brii Bio<\/span>,&#8221; or the &#8220;Company,&#8221;&nbsp;stock code: 2137.HK), a biotechnology company developing therapies to improve patient health across diseases with high unmet medical need, today announced the publication of results from its Phase 2 ENSURE study in the peer-reviewed journal&nbsp;<i>Nature Medicine<\/i>. The study evaluates&nbsp;the efficacy and safety of an siRNA, elebsiran,&nbsp;in combination with pegylated interferon alfa (PEG-IFN\u03b1), compared to PEG-IFN\u03b1 monotherapy. Furthermore, this study evaluates the potential role of an&nbsp;HBV therapeutic vaccine, BRII-179, in identifying immunologically responsive patients and improving hepatitis B surface antigen (HBsAg) loss rates.<\/p>\n<p>The article, titled &#8220;<i>Elebsiran and PEG-IFN\u03b1 for chronic hepatitis B infection: a partially randomized, open-label, phase 2 trial<\/i>&#8220;, is now available online [<a href=\"https:\/\/www.nature.com\/articles\/s41591-025-04049-z\" target=\"_blank\" rel=\"nofollow noopener\">link<\/a>].<\/p>\n<p>The ENSURE study was conducted in two parts in virally suppressed chronic HBV patients. In Part I (Cohorts 1-3), participants na\u00efve to BRII-179 were randomized to receive 48 weeks of PEG-IFN\u03b1 alone or in combination with elebsiran (200 mg or 100 mg administered every 4 weeks [Q4W]). In Part II (Cohort 4), participants previously treated with 9 doses of elebsiran and BRII-179 in a completed Phase 2 study (BRII-179-835-001) were categorized as BRII-179 anti-HBs responders or non-responders based on peak hepatitis B surface antibody (anti-HBs) levels (\u226510 IU\/L or &lt;10 IU\/L, respectively), and subsequently received 48 weeks of elebsiran (100 mg Q4W) plus weekly PEG-IFN\u03b1 in the ENSURE study.<\/p>\n<p>Key results from this publication include:<\/p>\n<ul type=\"disc\">\n<li><b>Cohorts 1-3<\/b>: At 24 weeks post-EOT, HBsAg loss was observed in 4 of 19 participants (21.1%) in Cohort 2 (elebsiran 200 mg + PEG-IFN\u03b1) and 6 of 18 participants (33.3%) in Cohort 3 (elebsiran 100 mg + PEG-IFN\u03b1), compared to 1 of 18 participant (5.6%) in Cohort 1 (PEG-IFN\u03b1 monotherapy).<\/li>\n<li><b>Cohort 4<\/b>: At 24 weeks post-EOT, HBsAg loss was observed in 9 of 31 participants (29.0%), with a notably higher response among BRII-179 anti-HBs responders (8\/19, 42.1%) compared to non-responders (1\/12, 8.3%). BRII-179 anti-HBs responders also achieved more rapid HBsAg reductions and HBsAg seroclearance compared to non-responders.<\/li>\n<li>Elebsiran and PEG-IFN\u03b1 combination therapy was generally safe and well tolerated across all cohorts.<\/li>\n<\/ul>\n<p>The randomized, active-controlled design of Cohorts 1-3 was a gold standard in validating&nbsp;the clinical benefit of elebsiran over PEG-IFN\u03b1 monotherapy, providing an important benchmark for future development of siRNA towards HBV functional cure.<\/p>\n<p>The novel design of Cohort 4 explored a patient response-guided treatment approach for more personalized decision-making, maximizing response rates in those most likely to benefit while avoiding unnecessary and lengthy treatments in others.<\/p>\n<p>Other important observations are 1) participants previously treated with BRII-179 and elebsiran experienced faster decline and loss of HBsAg, suggesting that BRII-179 may prime the immune system for improved responsiveness to subsequent curative therapy; 2) 50% (4\/8) of anti-HBs responders who achieved sustained HBsAg loss had baseline HBsAg levels exceeding 1,500 IU\/mL when enrolled in the previous BRII-179-835-001 study, suggesting that BRII-179 may elicit anti-HBs responses in patients with high baseline HBsAg levels. With its favorable safety profile, BRII-179 could play a unique role in priming and enriching patients regardless of the baseline HBsAg levels, expanding the population eligible for future curative regimens.<\/p>\n<p>&#8220;The ENSURE study was designed to provide much-needed clarity and to answer critical scientific questions about curative treatment for chronic hepatitis B,&#8221; said&nbsp;Professor Jidong Jia, lead principal investigator of the ENSURE study, &#8220;It is encouraging to see that the 24-week follow-up data remain consistent with the EOT results, substantiating the added clinical benefit of elebsiran and pointing to the potential new roles of BRII-179 in priming and enriching CHB patients for achieving higher cure rates. We look forward to validating these findings in confirmatory studies.&#8221;<\/p>\n<p><b>About Hepatitis B <\/b><\/p>\n<p>Hepatitis B virus (HBV) infection is one of the world&#8217;s most significant infectious disease threats with more than 254 million people infected globally.<sup>[1]<\/sup> Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.<sup>[1]<\/sup> HBV is of exceptional concern in <span class=\"xn-location\">China<\/span>, where 87 million people are chronically infected.<sup>[2]<\/sup><\/p>\n<p><b>About BRII-179<\/b><\/p>\n<p>BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In <span class=\"xn-chron\">November 2023<\/span>, the Center for Drug Evaluation (the &#8220;CDE&#8221;) of the National Medical Products Administration (the &#8220;NMPA&#8221;) granted BRII-179 Breakthrough Therapy Designation.<\/p>\n<p><b>About <\/b><b>Elebsiran <\/b><\/p>\n<p>Elebsiran is an investigational subcutaneously&nbsp;administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and&nbsp;limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral&nbsp;activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization&nbsp;Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially&nbsp;can result in an increased therapeutic index. Brii Bio&nbsp;licensed exclusive rights to develop and&nbsp;commercialize elebsiran for the&nbsp;Greater China territory from Vir Biotechnology, Inc. in 2020. In <span class=\"xn-chron\">May 2024<\/span>, the CDE of the NMPA granted elebsiran Breakthrough Therapy Designation.<\/p>\n<p><b>About <span class=\"xn-person\">Brii Bio<\/span><\/b><\/p>\n<p>Brii Biosciences Limited (&#8220;<span class=\"xn-person\">Brii Bio<\/span>&#8220;, stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including <span class=\"xn-location\">Raleigh-Durham<\/span>, the <span class=\"xn-location\">San Francisco Bay Area<\/span>, <span class=\"xn-location\">Beijing<\/span> and <span class=\"xn-location\">Shanghai<\/span>. For more information, visit <a href=\"http:\/\/www.briibio.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.briibio.com<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Findings provide scientific insights into the contribution of small interfering RNA (siRNA) and therapeutic vaccination towards the HBV functional cure strategy DURHAM, N.C. and BEIJING, Nov. 7, 2025 \/PRNewswire\/ &#8212; Brii Biosciences Limited (&#8220;Brii Bio,&#8221; or the &#8220;Company,&#8221;&nbsp;stock code: 2137.HK), a biotechnology company developing therapies to improve patient health across diseases with high unmet medical [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-41402","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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