This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2024
  • /
  • 6
  • /
  • Mim8 demonstrated superior reductions in annualise...
News

Mim8 demonstrated superior reductions in annualised bleeding rate compared to on-demand and prior prophylaxis treatment in people with haemophilia A.- Novo Nordisk

Read time: 2 mins
Published:23rd Jun 2024

FRONTIER2 data presented at ISTH 2024 showed that up to 95% of people, who had no prior prophylaxis treatment, experienced zero treated bleeds while on Mim8.

Novo Nordisk announced results from the phase III FRONTIER2 trial of 254 adults and adolescents aged 12 years and over with haemophilia A, with and without inhibitors. The trial assessed both once-weekly and once-monthly prophylactic treatment (regular treatment to prevent prolonged and spontaneous bleeding) with the investigational treatment Mim8. The data were presented at the International Society of Thrombosis and Haemostasis Annual Congress (ISTH 2024) in Bangkok, Thailand.

In the trial population with no prior prophylaxis treatment : i. Mim8 demonstrated a superior reduction in the estimated mean annualised bleeding rate (ABR) of treated bleeds by 97.1% with once-weekly and 98.7% with once-monthly Mim8. ii. Once-weekly and once-monthly Mim8 prophylaxis demonstrated a superior reduction in treated bleeds, as evidenced by an estimated mean ABR of 0.45 and 0.20 bleeds per patient-year, respectively, compared to an estimated mean ABR of 15.75 for those who received no prior prophylaxis treatment. iii.Zero bleeds were observed in 85.7% of people treated with once-weekly Mim8 and 95.0% of those treated with once-monthly Mim8.

In the trial population with prior coagulation factor prophylaxis :i. Mim8 demonstrated a superior reduction in the estimated mean ABR by 48% for once-weekly and 42.6% for once-monthly treatment. ii. Once-weekly and once-monthly Mim8 demonstrated a superior reduction in treated bleeds compared to prior coagulation factor prophylaxis. Estimated mean ABRs for treated bleeds were 2.51 bleeds per patient-year for once-weekly Mim8 (versus 4.83 on prior clotting factor prophylaxis) and 1.78 bleeds per patient-year for once-monthly Mim8 (versus 3.10 on prior clotting factor prophylaxis). iii. Zero bleeds were observed in 66.3% of participants treated with once-weekly Mim8 and 65.3% treated with once-monthly Mim8.

“Despite treatment advances, there are still many unmet needs for people living with haemophilia A,” said FRONTIER2 lead investigator Dr Maria Elisa Mancuso, Senior Consultant in Haematology, Centre for Thrombosis and Haemorrhagic Diseases, IRCCS Humanitas Research Hospital, Milan, Italy. “The FRONTIER2 data demonstrated superiority of Mim8 prophylaxis over both on demand treatment and prior clotting factor prophylaxis with respect to the number of treated bleeding episodes in people living with haemophilia A, regardless of their inhibitor status. It is also encouraging to see that in some subgroups in the study, up to 95% of people treated with Mim8 experienced zero bleeds.”

Mim8 is a next-generation Factor VIIIa (FVIIIa) mimetic bispecific antibody designed with the potential to deliver sustained haemostasis. It is currently in development for once-weekly or once-monthly prophylaxis treatment for people living with haemophilia A, with and without inhibitors. Administered subcutaneously, Mim8 bridges Factor IXa/X (FIXa/FX), thereby replacing missing FVIII. This restores the body’s thrombin generation capacity, helping blood to clot. In this trial, Mim8 was well-tolerated, and no safety concerns (thromboembolic events or related serious adverse events) were observed, in line with previous findings.

About the FRONTIER2 clinical trial: The FRONTIER phase III clinical development programme investigates Mim8 as a prophylactic treatment for people with haemophilia A, with or without inhibitors. The phase III programme includes FRONTIER2, FRONTIER3, FRONTIER4, and FRONTIER5.

FRONTIER2 is a 52-week efficacy and safety phase III trial, comparing once-weekly and once-monthly Mim8 versus no prophylaxis and versus prior coagulation factor prophylaxis (26-52-week run-in period) in people aged 12 years and over with haemophilia A, with or without inhibitors. The 26-week main phase of the trial is completed, a 26-week extension phase is ongoing. Participants were randomised into five treatment arms: Those who had received on-demand treatment prior to trial enrolment : i. Those in treatment arm 1 were randomised to continue no prophylaxis treatment and did not receive Mim8 in the main phase of the study. ii. Those in treatment arm 2a were randomised to receive once-weekly Mim8 prophylaxis. iii. Those in treatment arm 2b were randomised to receive once-monthly Mim8 prophylaxis.

Those who had received prophylaxis treatment prior to trial enrolment : i.Patients standard-of-care coagulation factor prophylaxis was documented in a 26-52 week run in, after which: a. Those in treatment arm 3 were randomised into the main part of the study to receive once-weekly Mim8 prophylaxis .b. Those in treatment arm 4 were randomised into the main part of the study to receive once-monthly Mim8 prophylaxis.

 

Condition: Haemophilia A
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Related news and insights