{"id":32720,"date":"2025-07-09T16:06:27","date_gmt":"2025-07-09T10:36:27","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32720"},"modified":"2025-07-09T16:06:29","modified_gmt":"2025-07-09T10:36:29","slug":"almb-0166-phase-i-ii-first-in-human-clinical-data","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/almb-0166-phase-i-ii-first-in-human-clinical-data","title":{"rendered":"ALMB-0166: A First-in-Class Astrocyte-targeting Therapy Shows Promise in Acute Spinal Cord Injury"},"content":{"rendered":"\n<ul class=\"wp-block-list\">\n<li><em>ALMB-0166, a <\/em><strong><em>novel monoclonal antibody<\/em><\/strong><em> targeting <\/em><strong><em>connexin-43 hemichannels<\/em><\/strong><em>, demonstrates favorable safety and neurological recovery signals in <\/em><strong><em>acute SCI patients<\/em><\/strong><em>.<\/em><\/li>\n\n\n\n<li><em>Early-phase data support continued clinical development of ALMB-0166 as a <\/em><strong><em>potential neuroprotective <\/em><\/strong><em>and <\/em><strong><em>regenerative therapy<\/em><\/strong><em> following <\/em><strong><em>traumatic spinal cord injury<\/em><\/strong><em>.<\/em><\/li>\n<\/ul>\n\n\n\n<p>At the <strong>EAN 2025 Congress<\/strong>, investigators from <strong>Peking Union Medical College Hospital<\/strong> and <strong>CSPC Pharmaceutical Group<\/strong> presented <strong>first-in-human clinical data<\/strong> from the Phase I\/II randomized, placebo-controlled trial evaluating ALMB-0166 in patients with acute cervical spinal cord injury (SCI). ALMB-0166 is a <strong>first-in-class humanized monoclonal antibody<\/strong> that blocks connexin-43 hemichannels in astrocytes, an emerging target thought to mitigate secondary injury and promote neuroregeneration after SCI.<\/p>\n\n\n\n<p><strong>EAN 2025 Coverage: Safety and Efficacy of Almb-0166 in Patients With Acute Spine Cord Injury (SCI): A Randomized, Phase I\/II Study<\/strong><\/p>\n\n\n\n<p>The study enrolled 24 adult patients with acute traumatic SCI (levels C3\u2013C7), <strong>American Spinal Injury Association (ASIA) Impairment Scale (AIS) Grades<\/strong> B or C, within 72 hours of injury. Participants were randomized to receive a single IV dose of ALMB-0166 (200\u20134800 mg) or placebo, alongside best supportive care. The primary objective was to assess <strong>safety<\/strong> and <strong>tolerability<\/strong>, with <strong>motor<\/strong>, <strong>sensory<\/strong>, and <strong>functional outcomes<\/strong> evaluated over 56 days.<\/p>\n\n\n\n<p><strong>Dosing Arms<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Cohorts 1\u20132: 200 mg and 600 mg (2:1 randomization)<\/li>\n\n\n\n<li>Cohorts 3\u20135: 1200 mg, 2400 mg, and 4800 mg (3:1 randomization).<\/li>\n<\/ul>\n\n\n\n<p><strong>Safety Profile&nbsp;<\/strong><\/p>\n\n\n\n<p>ALMB-0166 was well tolerated at all doses, with fewer high-grade AEs than placebo.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Safety Endpoint<\/strong><\/td><td><strong>ALMB-0166 (n = 17)<\/strong><\/td><td><strong>Placebo (n = 7)<\/strong><\/td><\/tr><tr><td><strong>Any TEAE<\/strong><\/td><td>94.1%<\/td><td>100%<\/td><\/tr><tr><td><strong>\u2265Grade 3 TEAEs<\/strong><\/td><td>17.6%<\/td><td>42.9%<\/td><\/tr><tr><td><strong>Common Grade \u22653 Events<\/strong><\/td><td>Hypokalemia, pulmonary inflammation, respiratory failure, deep venous thrombosis<\/td><td>Hypokalemia, hyponatremia<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Preliminary Efficacy Signals at Day 56<\/strong><\/p>\n\n\n\n<p>Patients receiving ALMB-0166 showed clinically meaningful improvements in motor, sensory, and functional scores versus placebo. These early signs of <strong>neurologic improvement<\/strong> and <strong>pain reduction<\/strong> support the therapeutic rationale of targeting astrocytic connexin-43 in the acute injury phase.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Endpoint<\/strong><\/td><td><strong>ALMB-0166<\/strong><\/td><td><strong>Placebo<\/strong><\/td><\/tr><tr><td><strong>Motor score change (2400 mg)<\/strong><\/td><td>+66.0<\/td><td>+45.6<\/td><\/tr><tr><td><strong>Sensory score change (600\u20131200 mg)<\/strong><\/td><td>+77.5, +62.7<\/td><td>+52.3<\/td><\/tr><tr><td><strong>AIS Grade E conversion<\/strong><\/td><td>2 patients<\/td><td>0 patients<\/td><\/tr><tr><td><strong>Pain reduction (VAS score)<\/strong><\/td><td>\u201344.3 (1200 mg), \u201323.7 (2400 mg)<\/td><td>\u201320.9<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>KOL Views<\/strong><\/p>\n\n\n\n<p>\u201cThis is a groundbreaking approach to spinal cord injury. ALMB-0166\u2019s mechanism is unique, and early clinical signals show functional improvements we rarely observe in this time frame.\u201d <strong>\u2013 Expert Opinion.<\/strong><\/p>\n\n\n\n<p>\u201cBlocking secondary damage via astrocyte connexin channels is a novel therapeutic angle. The encouraging safety and efficacy data warrant further development.\u201d <strong>\u2013 Expert Opinion.<\/strong><\/p>\n\n\n\n<p><strong>Conclusion<\/strong><\/p>\n\n\n\n<p>The <strong>Phase I\/II study<\/strong> of ALMB-0166 demonstrates a<strong> favorable safety profile <\/strong>and <strong>early signs of neurological benefit<\/strong> in patients with acute cervical SCI. As the first agent of its kind targeting astrocyte connexin-43 hemichannels, ALMB-0166 represents a <strong>promising neuroprotective strategy <\/strong>with the potential to <strong>fill a long-standing gap<\/strong> in acute SCI treatment. Further clinical development and expansion into larger confirmatory studies are warranted.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>At the EAN 2025 Congress, investigators from Peking Union Medical College Hospital and CSPC Pharmaceutical Group presented first-in-human clinical data from the Phase I\/II randomized, placebo-controlled trial evaluating ALMB-0166 in patients with acute cervical spinal cord injury (SCI). ALMB-0166 is a first-in-class humanized monoclonal antibody that blocks connexin-43 hemichannels in astrocytes, an emerging target thought [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":32722,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17126],"tags":[22601],"industry":[17225],"therapeutic_areas":[17245],"class_list":["post-32720","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-others","tag-ean-annual-congress","industry-pharmaceutical","therapeutic_areas-neurology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - 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