{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T23:40:16Z","timestamp":1777938016016,"version":"3.51.4"},"reference-count":32,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Mapi Pharma Ltd"},{"name":"Viatris, Inc."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>GA Depot is a long-acting glatiramer acetate (GA)-based formulation designed to provide significantly extended dosing intervals compared to currently available GA formulations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To assess GA Depot efficacy, safety, and tolerability compared to placebo in patients with relapsing multiple sclerosis (RMS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A 52-week multi-center, double-blind, placebo-controlled phase 3 trial in RMS. Patients aged 18\u201355 with an Expanded Disability Status Scale (EDSS) score\u2009\u2a7d\u20095.5 were enrolled and randomized (1:1) to intramuscular (IM) GA Depot 40\u2009mg or matching placebo every 4\u2009weeks. The primary endpoint was annualized relapse rate (ARR) at 52\u2009weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      A total of 1016 patients were treated with GA Depot (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009508) or placebo (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009508). Adjusted ARR was lower in patients treated with GA Depot compared to placebo (0.18, 95% confidence interval [CI] = 0.14 to 0.3 vs 0.26, 95% CI = 0.21 to 0.32, 30.1% relative risk reduction,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.0066). GA Depot significantly reduced the number of contrast-enhancing lesions (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.0083). The most common adverse events were injection site reactions (46.1% with GA Depot vs 28.7% with placebo), primarily mild and self-limited.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>GA Depot effectively reduced clinical and radiological activity compared to placebo in RMS patients, recapitulating the favorable profile of subcutaneous GA products with significantly less frequent injections.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration:<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Identifier: NCT04121221 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT04121221\">https:\/\/clinicaltrials.gov\/study\/NCT04121221<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585251405101","type":"journal-article","created":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T11:24:13Z","timestamp":1771413853000},"page":"202-213","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["GA Depot, a long-acting glatiramer acetate, vs placebo in patients with relapsing multiple sclerosis: A randomized phase 3 clinical trial"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8324-7356","authenticated-orcid":false,"given":"Aaron","family":"Miller","sequence":"first","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai, New York, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9245-9772","authenticated-orcid":false,"given":"Jeffrey A","family":"Cohen","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5625-7900","authenticated-orcid":false,"given":"Arnon","family":"Karni","sequence":"additional","affiliation":[{"name":"The Neuroimmunology and MS Unit, Neurology Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Gray Faculty of Medical &amp; Health Sciences and Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Popper","sequence":"additional","affiliation":[{"name":"Mapi Pharma Ltd., Ness Ziona, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nadav","family":"Bleich Kimelman","sequence":"additional","affiliation":[{"name":"Mapi Pharma Ltd., Ness Ziona, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shai","family":"Rubnov","sequence":"additional","affiliation":[{"name":"Mapi Pharma Ltd., Ness Ziona, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uri","family":"Danon","sequence":"additional","affiliation":[{"name":"Mapi Pharma Ltd., Ness Ziona, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ehud","family":"Marom","sequence":"additional","affiliation":[{"name":"Mapi Pharma Ltd., Ness Ziona, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexey","family":"Boyko","sequence":"additional","affiliation":[{"name":"Pirogovs Russian National Research University and Federal Center of Brain Research and Neurotechnologies, Moscow, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7799-1485","authenticated-orcid":false,"given":"Robert","family":"Zivadinov","sequence":"additional","affiliation":[{"name":"Buffalo Neuroimaging Analysis Center, University at Buffalo, State University of New York, Buffalo, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph R","family":"Berger","sequence":"additional","affiliation":[{"name":"University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7179-0335","authenticated-orcid":false,"given":"Amit","family":"Bar-Or","sequence":"additional","affiliation":[{"name":"University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hadar","family":"Kolb","sequence":"additional","affiliation":[{"name":"The Neuroimmunology and MS Unit, Neurology Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2026,2,18]]},"reference":[{"key":"e_1_3_2_2_2","article-title":"Glatopa (Glatiramer Acetate) Injection, 40 mg\/mL","author":"U.S. Food and Drug Administration","year":"2018","unstructured":"U.S. Food and Drug Administration. 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