{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T21:50:34Z","timestamp":1790113834994,"version":"4.0.1"},"reference-count":47,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T00:00:00Z","timestamp":1775606400000},"content-version":"am","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"AskBio Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and aims<\/jats:title>\n                    <jats:p>AB-1002 is an investigational, cardiotropic adeno-associated viral vector gene therapy expressing constitutively active form of protein phosphatase inhibitor-1 intended to restore cardiomyocyte calcium handling and improve cardiac contractility.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>GenePHIT is an adaptive, double-blinded, placebo-controlled, randomized multicentre Phase 2 trial evaluating the efficacy, safety, and tolerability of AB-1002 in adults with non-ischaemic cardiomyopathy with left ventricular ejection fraction of 15%\u201335% and New York Heart Association class III symptoms despite standard of care therapy. GenePHIT includes a 52-week observation period and 4-year long-term follow-up. Participants are randomized 1:1:1 (n = 30\u201350\/group) to receive a single antegrade intracoronary infusion of AB-1002 at 1 of 2 doses (7.15E13 or 1.43E14 viral genomes\/participant), or placebo. The primary endpoint will be assessed at 52 weeks and will comprise a hierarchical composite of cardiovascular death, change from baseline in New York Heart Association class, left ventricular ejection fraction improvement of \u22655%, and 6-minute walk test improvement of &amp;gt;30\u2005m, with pooled active doses compared to placebo via a win ratio estimate using Finkelstein-Schoenfeld methodology. Several other secondary efficacy, safety, and exploratory endpoints will be assessed at 52 weeks and through long-term follow-up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This Phase 2, placebo-controlled trial will further elucidate the risk-benefit characterization of single-dose AB-1002 in patients with non-ischaemic heart failure.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ejhf\/xuag105","type":"journal-article","created":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T11:46:54Z","timestamp":1775216814000},"source":"Crossref","is-referenced-by-count":3,"title":["AB-1002 gene therapy expressing active protein phosphatase inhibitor-1 in heart failure: rationale and study design of the GenePHIT trial"],"prefix":"10.1093","author":[{"given":"Timothy D","family":"Henry","sequence":"first","affiliation":[{"name":"The Carl and Edyth Lindner Center for 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,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelia G","family":"Kranias","sequence":"additional","affiliation":[{"name":"University of Cincinnati , Cincinnati, OH ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna P","family":"Tretiakova","sequence":"additional","affiliation":[{"name":"AskBio Inc. , Research Triangle Park, NC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah D","family":"Ascheim","sequence":"additional","affiliation":[{"name":"D2A Ltd , Los Angeles, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin R","family":"Saville","sequence":"additional","affiliation":[{"name":"Adaptix Trials LLC , Austin, TX ,","place":["USA"]},{"name":"Department of Biostatistics, Vanderbilt University Medical Center , Nashville, TN 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