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Matsushita discussed findings from the OLE FRONTIER4 study of Mim8.
Mim8 prophylaxis twice weekly was well tolerated in people with hemophilia A with no discontinuations, a few treated bleeds, and 84% of participants had zero treated bleeds.
These findings, from the open-label extension FRONTIER4 study, were presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 7-10, 2024, in San Diego, California, by Tadashi Matsushita, MD, PhD, Professor, Transfusion Medicine, Nagoya University Hospital.
“Mim8 has a small injection volume, and it is an subcutaneous injection. You don't have to do some intravenous injection every day, twice a day, so now it's not going to be necessary to inject intravenous injection,” Matsushita told HCPLive® during the meeting.
The study included 37 of 39 patients that completed the FRONTIER1 phase 2 extension. All adverse events (AEs) were non-serious, except 3 (in 2 patients), which were considered unlikely to be related to Mim8 and resolved.Participants had an estimated mean annualized bleeding rate of 0.4 (95% CI, 0.17-0.82) for treated bleeding episodes with Mim8 Q2W dosing.
Mim8 (denecimig) is a next-generation, activated factor VIII mimetic, fully human bispecific IgG4 antibody. In this interview, Matsushita discussed the safety findings in FRONTIER4 and overviewed advantages of Mim8 over current therapies for hemophilia A, including its subcutaneous, twice weekly dosing.
“I think this portability of the devices should be very welcomed by the patient,” Matsushita said.