Study: Mim8 Shows Reductions in Treated Bleeds for Patients With Hemophilia A

Mim8 had a safe and well-tolerated profile, with no deaths or thrombotic events reported for patients with hemophilia A.

The FRONTIER 2 (NCT05053139) trial met its co-primary end points of statistically significant and superior reductions in treated bleeding episodes once weekly and once monthly with Mim8 (Novo Nordisk) for those with hemophilia A compared with no prophylaxis treatment and prior coagulation factor prophylaxis treatment, according to a news release.¹

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Investigators included individuals who were diagnosed with congenital hemophilia A with any severity and who had been prescribed treatment with factor VIII or bypassing agent within 26 weeks prior to screening, according to the clinical trial information. Further, individuals were treated with on-demand or no prophylaxis prior to enrollment with 5 or more bleeds in the last 26 weeks before screening or individuals with factor VIII activity of 1% or more and were on prophylactic treatment with 1 or more bleed prior to screening.²

Individuals in arm 1 either received no prophylaxis or received Mim8 as once weekly or once monthly prophylaxis, then continued into the extension part of the study for 26 weeks with either dose of Mim8. In arm 2a, individuals received once weekly Mim8 in the main portion of the study and continued the dosage in the extension part. In arm 2b, individuals received once monthly prophylaxis of Mim8 during both parts of the study. Patients who did not initially received prophylaxis did not enter the run in-period for the 3 arms. Individuals in arm 3 received once weekly Mim8 in both parts of the study, and arm 4 received once monthly doses during both parts. In both of these arms, patients on coagulation factor prophylaxis before enrollment continued the same product in the run-in period, according to the clinical trial information.²

The primary outcomes included number of treated bleeds in all arms. The secondary outcomes included number of injection site reactions, occurrence of anti-Mim8 antibodies, number of treated spontaneous bleeds, number of treated joint bleeds, number of treated traumatic bleeds, number of target joint bleeds, consumption of factor product per bleed treatment, change in physical function domain of pediatric quality of life, change in patient’s treatment burden using the hemophilia treatment experience measure, and change in patient’s joint pain score using Joint Pain Rating Scale.²

For individuals who previously had no prophylaxis treatment, the once weekly and once monthly doses demonstrated reduction in treated bleeds of 97% and 99%, respectively, compared with those who received no prophylaxis. Additionally, 86% of those in the once weekly arm and 95% in the once monthly arm experienced 0 treated bleeds compared to 0% with no prophylaxis.¹

About The Trial

Trial Name: A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

ClinicalTrials.gov ID: NCT05053139

Sponsor: Novo Nordisk A/S

Completion Date (Estimated): September 2024

For patients who had prior coagulation factor prophylaxis, once weekly and once monthly doses showed reductions of 48% and 43% in treated bleeds, respectively. Further, 66% and 65% of patients, respectively, experienced 0 bleeds.¹

Generally, Mim8 had a safe and well-tolerated profile, with no deaths or thrombotic events reported.¹ Novo Nordisk aims to submit the drug for the first regulatory approval towards the end of 2024, and further data from the FRONTIER 2 trial will be presented at upcoming congresses and published in 2024 and 2025, according to the news release.¹

References

1. Novo Nordisk A/S: Once-weekly and once-monthly Mim8 demonstrate superior reduction of treated bleeding episodes compared to on-demand and prior prophylaxis treatment in people with haemophilia A in the Frontier 2 trial. News release. Novo Nordisk. May 13, 2024. Accessed May 31, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=168515

2. A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors. Novo Nordisk A/S. ClinicalTrials.gov identifier: NCT05053139. May 29, 2024. Accessed May 31, 2024. https://clinicaltrials.gov/study/NCT05053139