Don Tracy, Associate Editor

In the Phase IIIa FRONTIER 2 trial, participants aged 12 years and older administered Mim8 showed significant and superior reduction of treated bleeding episodes.
Novo Nordisk announced successful results from the Phase IIIa FRONTIER 2 trial, which evaluated the efficacy and safety of Mim8, a promising new treatment for hemophilia A. According to the company, this trial enrolled 254 participants over the age of 12 years to analyze the efficacy and safety of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and versus prior coagulation factor prophylaxis treatment. The trial met its two primary endpoints, which were to demonstrate significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly administration of Mim8.1
“We are very pleased with the positive results from the FRONTIER 2 clinical trial. These data demonstrate the ability of Mim8 to prevent bleeding episodes effectively and safely in people with hemophilia A, regardless of their dosing frequency,” said Martin Holst Lange, EVP, development, Novo Nordisk, in a press release. “Given the differing needs of people living with hemophilia A, a convenient once-weekly or once-monthly dosing provides optionality and flexibility for people living with hemophilia A with or without inhibitors.”
Additional findings include reductions of 97% and 99% in bleeding episodes for participants who did not receive prior prophylaxis treatment in both the once weekly and once monthly treatments, respectively, compared to those who were not administered prophylaxis treatment during the trial; zero bleeds experienced from 86% of those treated weekly and 95% for those treated monthly; and for patients previously on coagulation factor prophylaxis, once-weekly and once-monthly Mim8 reduced bleeding episodes by 48% and 43%, respectively. Min8 was reported to be well tolerated and didn’t present significant safety concerns.1
In 2022, Novo Nordisk announced that the Phase I and II FRONTIER1 trials had also offered promising results. For this study, once-weekly and once-monthly doses of Mim8 were administered under the skin, with the treatment being tolerated at all doses, regardless of inhibitor status.2
“We are committed to investigating novel approaches to address the individual and changing needs for people living with hemophilia,” said Lange, in a press release. “The data for Mim8 thus far present an opportunity to develop a treatment for people with hemophilia A who may benefit from less frequent administration. We look forward to moving into next steps with this investigational therapy.”
According to the Centers for Disease Control and Prevention, around 400 babies are born with hemophilia A annually. On average, diagnosis is most common at a young age in the United States, with a median diagnosis age of three years old for mild hemophilia, eight months for moderate, and one month if its severe. In a majority of cases, there is a family history of hemophilia.3
Novo Nordisk is aiming to apply for regulatory approval for Mim8 by the end of 2024, based on the results of the FRONTIER 2 trial. The company also intends to publish additional data throughout 2024 and 2025 in upcoming congresses and publications.1