Fase I-resultaten van onderzoek naar Chugais bispecifieke antilichaam ACE910/emicizumab tegen hemofilie-A gepubliceerd in New England Journal of Medicine Online
TOKYO–(BUSINESS WIRE)– Chugai Pharmaceutical Co., Ltd. heeft vandaag bekendgemaakt dat de resultaten van hemofilie-A-patiënten die deelnemen aan een fase I-onderzoek naar het bispecifieke antilichaam emicizumab (het onderzoek ACE001JP) online zijn gepubliceerd in The New England Journal of Medicine, op 25 mei 2016. Emicizumab is momenteel in ontwikkeling voor de behandeling van hemofilie-A. Dit onderzoek – het eerste waaraan patiënten deelnamen – toonde aan dat een wekelijkse onderhuidse injectie met emicizumab een klinisch acceptabel veiligheidsprofiel heeft en potentiële voordelen herbergt bij het voorkomen van bloedingen van mensen met hemofilie-A, mét en zonder inhibitoren van factor VIII.
http://www.nejm.org/doi/full/10.1056/NEJMoa1511769
Chugai’s Bispecific Antibody “ACE910/Emicizumab” Phase l Data in Patients with Hemophilia A Published in The New England Journal of Medicine Online |
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TOKYO–(BUSINESS WIRE)– Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the data from hemophilia A patients who participated in a Phase I study of the bispecific antibody emicizumab (ACE001JP study) was published online in The New England Journal of Medicine (NEJM) on May 25, 2016 (EST). Emicizumab is currently under development for hemophilia A. In this first-in-patient Phase I study, a once-weekly subcutaneous injection of emicizumab demonstrated a clinically acceptable safety profile and a potential benefit for preventing bleeding in hemophilia A patients, both with and without factor VIII (FVIII) inhibitors. The patient part of ACE001JP study enrolled 18 Japanese hemophilia A patients, both with and without FVIII inhibitors, to investigate the safety and to explore the potential benefit of emicizumab for preventing bleeding with regular injection. In this open-label study, patients were treated with once-weekly subcutaneous injection of emicizumab across three dosing cohorts for 12 successive weeks. The study results had been presented at the 56th American Society of Hematology (ASH) Annual Meeting held in San Francisco, CA on December 8, 2014. “A great challenge with the current treatments for hemophilia A is that these patients need frequent intravenous injections and face the possibility of developing inhibitors to FVIII,” said Chugai’s Director and Executive Vice President, Dr. Yutaka Tanaka. “The study results indicated a potential for benefit from emicizumab in treating hemophilia A patients with inhibitors with once-weekly subcutaneous injection. With these findings, we expect that emicizumab may be a new treatment option to fulfill unmet medical needs of hemophilia A patients.” Emicizumab was designated as a Breakthrough Therapy by the US Food and Drug Administration in September 2015. Currently, a Phase III global study in hemophilia A patients with FVIII inhibitors is being conducted in collaboration with Roche, Chugai’s strategic alliance partner. Phase III global studies in patients without FVIII inhibitors and pediatric patients are also planned for initiation in 2016. The data of the healthy subject parts of ACE001JP study was published in Blood online, the journal published by ASH, on December 1, 2015.
Study results POTENTIAL BENEFIT
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