{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T14:12:41Z","timestamp":1785247961726,"version":"3.55.0"},"reference-count":36,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,12,30]],"date-time":"2022-12-30T00:00:00Z","timestamp":1672358400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Muscle and Nerve"],"published-print":{"date-parts":[[2023,5]]},"abstract":"Abstract<\/jats:title>Introduction\/Aims<\/jats:title>IC14 (atibuclimab) is a monoclonal anti\u2010CD14 antibody. A previous phase 1 trial of 10 participants with amyotrophic lateral sclerosis (ALS) demonstrated initial safety of IC14 in an acute treatment setting. We provided long\u2010term treatment with IC14 to individuals with ALS via an expanded access protocol (EAP) and documented target engagement, biomarker, safety, and disease endpoints.<\/jats:p><\/jats:sec>Methods<\/jats:title>Participants received intravenous IC14 every 2\u2009weeks. Consistent with United States Food and Drug Administration guidelines, participants were not eligible for clinical trials and the EAP was inclusive of a broad population. Whole blood and serum were collected to determine monocyte CD14 receptor occupancy (RO), IC14 levels, and antidrug antibodies. Ex vivo T\u2010regulatory functional assays were performed in a subset of participants.<\/jats:p><\/jats:sec>Results<\/jats:title>Seventeen participants received IC14 for up to 103\u2009weeks (average, 30.1\u2009weeks; range, 1 to 103\u2009weeks). Treatment\u2010emergent adverse events (TEAEs) were uncommon, mild, and self\u2010limiting. There were 18 serious adverse events (SAEs), which were related to disease progression and unrelated or likely unrelated to IC14. Three participants died due to disease progression. Monocyte CD14 RO increased for all participants after IC14 infusion. One individual required more frequent dosing (every 10\u2009days) to achieve over 80% RO. Antidrug antibodies were detected in only one participant and were transient, low titer, and non\u2010neutralizing.<\/jats:p><\/jats:sec>Discussion<\/jats:title>Administration of IC14 in ALS was safe and well\u2010tolerated in this intermediate\u2010size EAP. Measuring RO guided dosing frequency. Additional placebo\u2010controlled trials are required to determine the efficacy of IC14 in ALS.<\/jats:p><\/jats:sec>","DOI":"10.1002\/mus.27775","type":"journal-article","created":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T14:24:22Z","timestamp":1671459862000},"page":"354-362","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Safety and activity of anti\u2010CD14<\/scp> antibody IC14<\/scp> (atibuclimab) in ALS<\/scp>: Experience with expanded access protocol"],"prefix":"10.1002","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8287-5331","authenticated-orcid":false,"given":"Dario","family":"Gelevski","sequence":"first","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grace","family":"Addy","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margot","family":"Rohrer","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Cohen","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aimee","family":"Roderick","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison","family":"Winter","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Carey","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Scalia","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Yerton","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harli","family":"Weber","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Doyle","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"Parikh","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geli","family":"Kane","sequence":"additional","affiliation":[{"name":"Department of Neurology Sean M. 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