Regulatory Novo Creates a Favorable Picture for the Medicine Used...

Novo Creates a Favorable Picture for the Medicine Used to Prevent Hemophilia

-

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.

Life Sciences Voice Logo mobile
+ posts

Latest news

Sionna Therapeutics Targets $156 Million in IPO to Advance Cystic Fibrosis Research

Sionna Therapeutics, a biotechnology firm headquartered in Waltham, Massachusetts, is preparing to raise up to $156 million through an...

AdvanCell Bags $112M in Series C Funding For Alpha Radiopharma Trial

AdvanCell has raised $112 million in a Series C fundraising round supported by Sanofi Ventures. The Australian radiopharmaceutical firm...

Atalanta Therapeutics Secures $97 Million to Advance siRNA Therapies for Neurological Disorders

Atalanta Therapeutics has raised $97 million in a successful Series B financing round, which will support the initiation of...

Must read

Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm

You might also likeRELATED
Recommended to you