While Novo Nordisk have remained focused on the rare blood disorders market, they have continued to research and market drugs within this space and have pointed to Mim8’s potential. It is also active in the sickle cell disease space, having bought Forma Therapeutics the previous year while also progressing with another disease drug it licensed in 2018.
Ozempic, a diabetes drug, and Wegovy, an obesity drug produced by Novo, have propelled the Danish pharma firm into becoming the second-largest pharma firm.
In the case of Mim8, the recent outcomes represent the first from a phase 3 program that involves four other trials apart from Frontier 2. These results were obtained after Novo had recruited 254 people with hemophilia A to the Frontier-2 trial, including those with the “inhibitors” that make standard drugs fail in clotting the blood. The one-year study contrasted Mim8 with either no prophylactic anticoagulation if the patient was not on preventive treatment or with prior coagulation factor prophylaxis if the patient was.
In the former group, the patients received Mim8 as a once-weekly dosage, which brought down the average Annualized Bleeding Rate by 97%. The others who received Mim8 as a once-monthly dosage experienced a drop of 99% in the same parameter. The control arm of patients who did not receive preventative treatment had an average bleeding rate of 15.
Among participants in the once-weekly group, they reported having treated an average of 45 bleeds per patient-year. In the once-monthly group, the average was 0. The study included 20 patients from the targeted health facility who were once-monthly patients. The preventing average in the control arm of patients who did not receive preventative treatment was 15.
The Mim8 allosteric antagonist program is progressing at Novo. The company expects to file an approval application at the end of the year and share more trial data at upcoming medical meetings. This type of antibody, called “bispecific,” acts as a linker between Factors IXa and X instead of the deficient Factor VIII in patients with hemophilia A.
