The open-label, crossover, multi-centre Phase III BASIS trial (NCT03938792) included 116 people with haemophilia who were first observed with either regular prophylaxis or on-demand infusions of factor VIII or IX. After six months, groups were switched over to once-a-week treatment with marstacimab for one year.
Patients who first received regular prophylactic infusions showed a 35% decrease in their annual rate of bleeding events (ABR) when on marstacimab. While the group that was getting on-demand treatment reported a 92% decrease in their ABR when on the antibody treatment.
The safety profile for marstacimab was consistent with Phase I/II results and treatment was generally well-tolerated.
Pfizer’s marstacimab acts as an anti-tissue factor pathway inhibitor (anti-TFPI). This mechanism of action is differentiated from factor VIII or IX replacement treatments that are the current treatment standard for haemophilia.
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GlobalData (GD) analysts expect total haemophilia A and B markets to grow to US $14.71 billion in 2030, with US sales accounting for 55.6% of the total sales. GD has identified gene therapies as a growing market that will account for 37% of the US haemophilia drug market in 2030.
GlobalData is the parent company of Clinical Trials Arena.
Pfizer also has two gene therapies in pipeline for haemophilia. It released Phase III results on its haemophilia B gene therapy late last year, showing that it cut bleeds and reliance on factor IX infusions. It is developing a haemophilia A gene therapy in partnership with Sangamo Therapeutics.