Denecimig (Mim8) prophylaxis over 52 weeks in adolescents and adults with hemophilia A: FRONTIER2 extension study.

What was studied

This was an extension of a trial of denecimig, also called Mim8. It is an antibody in development to prevent bleeding in hemophilia A. It is injected under the skin. People were aged 12 years or older. In the main phase, 281 people were randomized. 272 entered the extension. In all, the study ran for 52 weeks.

What they found

Bleeding rates were low. Yearly rates ranged from 0.21 to 2.02 in the treated arms. People who switched from on-demand care had rates of 0.67 on weekly dosing. They had 0.79 on monthly dosing. Most target joints that bled at the start healed. There were no allergic reactions. There were no blood clots. No neutralizing antibodies were seen. Some injection-site reactions occurred. Physical function got better. Joint pain and treatment burden fell.

What it means for patients

The authors say denecimig kept bleeding rates low over 52 weeks. They say it was well tolerated. They say it improved patient-reported outcomes in people with hemophilia A with or without inhibitors.

Why it is not certain yet

In the extension, the on-demand group switched to denecimig. So there was no ongoing comparison group. The study ran for 52 weeks. The abstract does not give long-term safety beyond that.

Source

Denecimig (Mim8) prophylaxis over 52 weeks in adolescents and adults with hemophilia A: FRONTIER2 extension study.

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