Novo Nordisk has announced positive interim results for its Mim8 antibody which is being as a treatment for haemophilia A.
Novo Nordisk presented interim results from the Phase I & II FRONTIER1 dose-escalation study at International Society of Thrombosis and Haemostasis Annual Congress (ISTH 2022) in London, UK.
The study is assessing the safety and clinical use of Mim8 in patients with haemophilia A. Interim results of the study show that a once-weekly and once-monthly under the skin administration of Mim8 in people with haemophilia A was tolerated at all doses, regardless of inhibitor status.
Interim results from 32 patients showed that six of seven participants in the lowest dose cohort still reported at least one bleed, whereas at high doses, only two of the 25 patients reported bleeds. Zero bleeds were reported in the eight participants treated with the therapy once monthly.
Mim8 is a next-generation human IgG4 bispecific antibody bridging Factor IXa/X (FIXa/FX) designed as a once-a-week or once monthly treatment for haemophilia A with or without inhibitors. The antibody brings FIXa and FX together thereby replacing missing FVIII, which in turn stimulates production of thrombin that helps blood to clot.
“Mim8 demonstrated clinical proof-of-concept and no safety signals or signs of exaggerated coagulation were seen, which supports the further clinical development of Mim8 in people living with haemophilia A in phase 3 clinical trials,” said principle investigator Professor Jerzy Windyga, MD, Department of Hemostasis Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland. “We are encouraged by the first phase 1 & 2 data from FRONTIER1.”
“We are committed to investigating novel approaches to address the individual and changing needs for people living with haemophilia,” said Martin Lange, executive vice president and head of Development at Novo Nordisk. “The data for Mim8 thus far present an opportunity to develop a treatment for people with haemophilia A who may benefit from less frequent administration. We look forward to moving into next steps with this investigational therapy.”