Ahead of an FDA filing later this year, Novo Nordisk on Sunday offered up more detailed hemophilia A data from its Phase 3a trial investigating Mim8, a factor VIIIa mimetic bispecific antibody. The results show improvements in the number of treated bleeding episodes and superiority over other treatments.
For patients who had no prior prophylaxis treatment, the drug reduced the mean annual bleeding rate by 97.1% when given once a week and by 98.7% when given once a month, the Danish company said.
It was also superior in the reduction in treatment bleeds, Novo said, with a mean annual bleeding rate considerably lower than those with no treatment, Novo said.
“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,” FRONTIER2 lead investigator Maria Elisa Mancuso said in a statement.
Mim8 is being investigated as both a once-weekly and once-monthly treatment in Novo’s FRONTIER2 study, and the company unveiled the data at the International Society on Thrombosis and Haemostasis Annual Congress over the weekend.
As Novo Nordisk previously reported in May, zero bleeds were seen in 85.7% of people treated once a week and 95% of those treated once a month.
Martin Holst LangeNovo executive VP of development Martin Holst Lange pointed out the drug showed no safety concerns, with no treatment-related serious adverse events.
Jefferies analysts wrote that the full data show it’s more convenient than Roche’s competitor drug Hemlibra and “at least as effective,” with Novo’s overall data nearing their “best-case scenario.”
“Importantly, as per our experts, we view low injection site reaction frequency with monthly doses to be competitively attractive, hence we continue to see risk to Hemlibra consensus,” Jefferies analysts wrote.
“We have strong inspirations for Mim8, but I don’t think it’s for me to speculate on a new standard of care,” Lange said of the potential for Novo’s candidate to become the new treatment of choice. “But I think with the data that we see, we believe that Mim8 has a lot to offer to patients.”