{"id":10527,"date":"2022-07-26T23:00:00","date_gmt":"2022-07-26T23:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3827457_AE27457_0"},"modified":"2022-07-26T23:00:00","modified_gmt":"2022-07-26T23:00:00","slug":"brii-biosciences-announces-positive-data-demonstrating-its-long-acting-covid-19-neutralizing-antibody-therapy-amubarvimab-romlusevimab-combination-retains-neutralizing-activity-against-live-omicron","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=10527","title":{"rendered":"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"},"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<p><i>Independent lab results demonstrate that the combination therapy retains neutralizing activity against currently dominant COVID-19 strains, as previously demonstrated with all variants of concern to date<\/i><\/p>\n<p><i>The amubarvimab\/romlusevimab combination is commercially available in <span class=\"xn-location\">China<\/span> and is under review for Emergency Use Authorization by the U.S. Food and Drug Administration (FDA)<\/i><\/p>\n<p><span class=\"xn-location\">DURHAM, N.C.<\/span> and <span class=\"xn-location\">BEIJING<\/span>, <span class=\"xn-chron\">July 27, 2022<\/span> \/PRNewswire\/ &#8212;&nbsp;<a href=\"https:\/\/www.briibio.com\/index.php\" target=\"_blank\" rel=\"nofollow noopener\">Brii Biosciences<\/a> Limited&nbsp;(&#8220;Brii Bio&#8221; or the &#8220;Company&#8221;, 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 new live virus data confirming that the amubarvimab\/romlusevimab combination, a long-acting COVID-19 monoclonal antibody (mAb) therapy, retains neutralizing activity against the Omicron BA.4\/5 and BA.2.12.1 SARS-CoV-2 subvariants.<\/p>\n<p>Data from the live virus neutralization assay performed at a <span class=\"xn-org\">University of Maryland<\/span> lab certified by the U.S. National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) predict that total serum concentrations of the amubarvimab\/romlusevimab combination will remain greater than 170 times the level required for greater than 90% neutralization (Neut99: 0.94 \u03bcg\/mL) against the live virus, 14 days post dose.&nbsp;As a result, adequate therapeutic exposures are expected to persist throughout the treatment period.<\/p>\n<p>The mutations found in the BA.4\/5 and BA.2.12.1 subvariants spike protein confer a limited reduction in neutralization activity from wild-type SARS-CoV-2. Based on the human pharmacokinetic data gathered on the amubarvimab\/romlusevimab combination, exposures of intravenous amubarvimab 1000mg and romlusevimab 1000mg are expected to remain above the level required for neutralizing activity against BA.4\/5 and BA.2.12.1, for the treatment of COVID-19.<\/p>\n<p>&#8220;As the COVID-19 pandemic continues to surge with evolving variants, these data further validate the durability and longevity of our long-acting amubarvimab\/romlusevimab combination treatment and reinforce its position as a leading investigational monoclonal antibody therapy with potential to retain activity against the most dominating strains that are circulating worldwide,&#8221; said <span class=\"xn-person\">David Margolis<\/span>, M.D., MPH, Vice President and Head of Infectious Diseases Therapy Area at Brii Bio. &#8220;We&#8217;re at a critical moment in the pandemic in which the new Omicron subvariants are more contagious, resulting in a sustained urgency for safe and effective treatment options. We look forward to continuing our discussions with global regulatory bodies as we work to advance this innovative combination therapy for COVID-19 patients in need around the world.&#8221;<\/p>\n<p>On <span class=\"xn-chron\">December 8, 2021<\/span>, the National Medical Products Administration (NMPA) of <span class=\"xn-location\">China<\/span> approved the amubarvimab\/romlusevimab combination for the treatment of adults and pediatric patients (age 12-17 weighing at least 40 kg) with mild and normal type of COVID-19 at high risk for progression to severe disease, including hospitalization or death. The indication of pediatric patients (age 12-17 weighing at least 40 kg) is under a conditional approval. On <span class=\"xn-chron\">March 15, 2022<\/span>, the National Health Commission of <span class=\"xn-location\">China<\/span> added the amubarvimab\/romlusevimab combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition) for the treatment of COVID-19. On <span class=\"xn-chron\">July 7, 2022<\/span>, the amubarvimab\/romlusevimab combination was made commercially available in <span class=\"xn-location\">China<\/span>.<\/p>\n<p>The U.S. FDA is currently reviewing Brii Bio&#8217;s Emergency Use Authorization application for the amubarvimab\/romlusevimab combination.<\/p>\n<p><b>About Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab\/Romlusevimab Combination<\/b><\/p>\n<p>Amubarvimab and Romlusevimab are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients developed in collaboration with the 3rd People&#8217;s Hospital of <span class=\"xn-location\">Shenzhen<\/span> and Tsinghua University. They have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect.<\/p>\n<p>Based on the final results from the U.S. National Institutes of Health (NIH)\/National Institute of Allergy and Infectious Diseases (NIAID)-sponsored ACTIV-2 Phase 3 clinical trial with 837 enrolled outpatients, the amubarvimab\/romlusevimab combination demonstrates a statistically significant 80% reduction of hospitalization and death with fewer deaths through 28 days in the treatment arm (0) relative to placebo (9), and improved safety outcome over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease. Similar efficacy rates were observed in participants initiating therapy early (0-5 days) and late (6-10 days), following symptom onset, providing critically needed clinical evidence in COVID-19 patients who were late for treatment.<\/p>\n<p>The live virus testing data, as well as pseudovirus testing data from multiple independent labs, have demonstrated that the amubarvimab\/romlusevimab combination retains activity against major SARS-CoV-2 variants of concern, including the following commonly identified variants, B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon), B.1.617.2 (Delta), AY.4.2 (Delta Plus), C.37 (Lambda), B.1.621 (Mu), B.1.1.529-BA.1 (Omicron), and BA.1.1, BA.2, BA.2.12.1, BA.4\/5 (Omicron subvariants).<\/p>\n<p><b>About Brii Bio<\/b><\/p>\n<p>Brii Biosciences Limited (&#8220;Brii Bio&#8221;, or the &#8220;Company&#8221;, stock code: 2137.HK) is a biotechnology company based in <span class=\"xn-location\">China<\/span> and <span class=\"xn-location\">the United States<\/span> 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 <span class=\"xn-location\">China<\/span> and worldwide. 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>Independent lab results demonstrate that the combination therapy retains neutralizing activity against currently dominant COVID-19 strains, as previously demonstrated with all variants of concern to date The amubarvimab\/romlusevimab combination is commercially available in China and is under review for Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) DURHAM, N.C. and BEIJING, July [&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-10527","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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