B-LONG PHASE3 COMPLETED n=123
Drug: Alprolix · SOBI
Study Design
DesignOpen-label, multicenter, four-arm
Enrollment123
Treatment Arms
Weekly prophylaxis 50 IU/kg weekly n=63
Individualized interval 100 IU/kg every 10-14 days n=29
On-demand 20-100 IU/kg per bleed n=27
Perioperative Per surgical need n=12
Primary Endpoints
[{"id":"blong-ep1","name":"ABR on individualized interval prophylaxis","type":"PRIMARY","unit":"bleeds/year","results":[{"arm":"blong-ind","label":"Median ABR 1.38 (Q10-14 day dosing)","value":1.38},{"arm":"blong-wk","label":"Median ABR 2.95 (weekly)","value":2.95}],"description":"Alprolix achieves a 3x half-life extension for Factor IX (82-86 hours vs ~25 for standard). This enables dosing every 10-14 days - a genuine quality-of-life improvement for hemophilia B patients who previously needed twice-weekly infusions."}]
Safety Results
0 inhibitors across all clinical studies. No serious treatment-related AEs. Excellent/good hemostasis in all 12 surgical patients. Very clean safety profile.
Assessment
Alprolix is more differentiated in Hem B than Elocta is in Hem A. The 3x half-life extension enables truly extended-interval dosing. 0 inhibitors across all studies is reassuring. Revenue declining as Hem B is small and gene therapy emerging, but still an important orphan franchise for SOBI.
Background & Context
FIX Fc-fusion achieves better half-life extension (3x) than FVIII Fc-fusion (1.5x) because FIX is smaller and recycles more efficiently through FcRn. Enables truly extended-interval prophylaxis.
Data from Supabase · Updated 2026-03-24