Bi -Specific to Novo for Pediatric Test of Hemophilia ACES Phase III

Novo nordisk declared Positive results phase III results on Friday because of its study of the bouting antibody MIM8 for hemophilia A. The reporting, which follows such a victory in adults and adolescents last year, potentially puts Novo on the way to compete in a space -dominated space by Roche’s Hemlibra.

New plans to submit for approval of MIM8 in both the US and EU this year.

The Frontier3 test enrolled 70 children aged 1 to 11, with hemophilia A with and without inhibitors for 26 weeks. The survey struck its main endpoints of safety and tolerability without reporting major adverse events.

As for efficacy, none of the 14 children with inhibitors has experienced bleeding requiring treatment with coagulation factors. Among all participants, the annual frequency of treated bleeding reached 0.53, with 74.3% not experiencing bleeding that requires treatment during the test. Novo also reports improvements in the physical functioning of children as a run, as well as other quality of life, compared to the output line. After 26 weeks, 98% of the carers said they preferred the new MIM8 treatment of any treatment that the children had previously received.

“The FRONTIER3 intermediate analysis data is encouraging for families with young children and shows that MIM8 can offer an effective, convenient, flexible option for dosing children, helping to reduce the weight of treatment so that families can live more normal Life, “Johnny Mahlang, the study of chief investigator, said in a statementS

Friday’s message is the latest in a series of positive results for MIM8, which also improved the annual frequency of bleeding in the associated phase III Fronters2 Test in adults and adolescents. This study also showed that the bouting antibody can be used prophylactically and monthly. And in the earlier phase I/II trial border1, mim8 generated Clinically significant amounts of thrombin, clotting factor greatly reduced in hemophilia A.

Currently Novo is conducting another Phase III test, Frontier4For a further study of the safety of prophylactic administration of MIM8. Early Analysis The intermediate data from this test show no adverse effects.

Although positive, it remains unclear whether Novo’s data package for MIM8 will be sufficient to compete with Roche’s Hemlibra, which is approved for both adults and children and is rooted in the market since 2017.

Also on the go to seize a piece of hemophilia market – which is forecast To exceed $ 28 million in the United States by 2034 – is Pfizer. Last July Pharmacy reported Positive Phase III results In adult patients, Giroctocogene FitelparVovec, which corresponds to the basic and second endpoints of the test, showing a superiority to the infusions of factor VIII. Pfizer is currently offering Beqvez for hemophilia B.

Explanation (February 7): This article has been updated to clarify that the Frontier3 test has enrolled in a total of 70 children, aged 1 to 11 years, with hemophilia A with and without inhibitors.