{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T14:33:06Z","timestamp":1747146786993,"version":"3.40.5"},"reference-count":11,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,11,11]],"date-time":"2022-11-11T00:00:00Z","timestamp":1668124800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Birth Defects Research"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Achondroplasia is an autosomal disorder caused by point mutation in the gene encoding fibroblast growth factor receptor 3 (FGFR3) and resulting in gain of function. Recifercept is a potential disease modifying treatment for achondroplasia and functions as a decoy protein that competes for ligands of the mutated FGFR3. Recifercept is intended to restore normal bone growth by preventing the mutated FGFR3 from negative inhibitory signaling in pediatric patients with achondroplasia. Here we evaluated the potential effects of twice weekly administration of recifercept to juvenile cynomolgus monkeys (approximately 3\u2010months of age at the initiation of dosing) for 6\u2010months. No adverse effects were noted in this study, identifying the high dose as the no\u2010observed\u2010adverse\u2010effect\u2010level and supporting the use of recifercept in pediatric patients from birth. Considering that juvenile toxicity studies in nonhuman primates are not frequently conducted, and when they are conducted they typically utilize animals \u22659\u00a0months of age, this study demonstrates the feasibility of executing a juvenile toxicity study in very young monkeys prior to weaning.<\/jats:p>","DOI":"10.1002\/bdr2.2124","type":"journal-article","created":{"date-parts":[[2022,11,11]],"date-time":"2022-11-11T15:07:59Z","timestamp":1668179279000},"page":"348-356","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Juvenile toxicity study of <scp>PF<\/scp>\u201007256472\/recifercept, a recombinant human soluble fibroblast growth factor receptor 3, in 2\u20133\u2010month\u2010old cynomolgus monkeys"],"prefix":"10.1002","volume":"115","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8328-7718","authenticated-orcid":false,"given":"Sarah N.","family":"Campion","sequence":"first","affiliation":[{"name":"Pfizer Worldwide Research, Development and Medical  Groton Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2425-2603","authenticated-orcid":false,"given":"Christopher J.","family":"Bowman","sequence":"additional","affiliation":[{"name":"Pfizer Worldwide Research, Development and Medical  Groton Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antje","family":"Fuchs","sequence":"additional","affiliation":[{"name":"Labcorp Early Development Services GmbH  Muenster Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Karanian","sequence":"additional","affiliation":[{"name":"Pfizer Worldwide Research, Development and Medical  Groton Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Payal","family":"Rana","sequence":"additional","affiliation":[{"name":"Pfizer Worldwide Research, Development and Medical  Groton Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregg D.","family":"Cappon","sequence":"additional","affiliation":[{"name":"Pfizer Worldwide Research, Development and Medical  Groton Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,11,11]]},"reference":[{"issue":"2","key":"e_1_2_8_2_1","first-page":"368","article-title":"Achondroplasia is defined by recurrent G380R mutations of FGFR3","volume":"56","author":"Bellus G. A.","year":"1995","journal-title":"American Journal of Human Genetics"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0192623310368981"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.etp.2006.07.003"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.3006247"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0244368"},{"key":"e_1_2_8_7_1","unstructured":"ICH. (2020).S11 Guidance on nonclinical safety testing in support of development of paediatric pharmaceuticals."},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00401402"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdrb.20305"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/371252a0"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1293\/tox.25.63"},{"volume-title":"Primate biologics research at a crossroads","year":"2015","author":"Weinbauer G. F.","key":"e_1_2_8_12_1"}],"container-title":["Birth Defects Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bdr2.2124","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bdr2.2124","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bdr2.2124","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T03:51:18Z","timestamp":1692503478000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/bdr2.2124"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,11]]},"references-count":11,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023,2]]}},"alternative-id":["10.1002\/bdr2.2124"],"URL":"https:\/\/doi.org\/10.1002\/bdr2.2124","archive":["Portico"],"relation":{},"ISSN":["2472-1727","2472-1727"],"issn-type":[{"type":"print","value":"2472-1727"},{"type":"electronic","value":"2472-1727"}],"subject":[],"published":{"date-parts":[[2022,11,11]]},"assertion":[{"value":"2022-07-25","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-10-26","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-11-11","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}