Single intravenous administration of TB-402 for the prophylaxis of VTE after total knee replacement surgery

Total VTE was lower in each of the TB-402 groups compared to the enoxaparin group: 16.7% (9.8-26.9), 23.9% (15.3-35.3), 24.1%(16.0-34.5) and 39.0%(28.8-50.1) for TB-402 0.3mg/kg, 0.6mg/kg, 1.2mg/kg and enoxaparin, respec?vely (p=0.003 for TB-402 0.3 mg/kg vs enoxaparin) (Table 2). A comparison of the pooled TB-402 groups versus the enoxaparin group demonstrated a reduc?on in the incidence of the primary efficacy outcome (47/218; 22%(95%CI:17-28) vs 30/77; 39%(95%CI:29-50) p<0.05). Major or clinically relevant non-major bleeding was observed in 3/75(4.0%), 4/74(5.4%), 7/87(8.0%) and 3/79(3.8%) pa?ents for TB-402 0.3mg/kg, 0.6mg/kg, 1.2mg/kg and enoxaparin, respec?vely. The drug was well-tolerated. Two deaths occurred during the study, both were considered unrelated to the study drug. N= 72 N= 67 N=79 N=77 Total VTE n (%) 12 (16.7%) 16 (23.9%) 19 (24.1%) 30 (39.0%) (95 C.I.) (9.8-26.9) (15.3-35.3) (16.0-34.5) (28.8-50.1) Major VTE n (%) 1 (1.4%) 0 (0%) 1 (1.3%) 3 (3.9%) Major Bleeding n (%) 0 (0%) 1 (1.4%) 4 (4.6%) 0 (0%) CRNMB n (%) 3 (4.0%) 3 (4.1%) 3 (3.4%) 3 (3.8%) TB‑402 0.3 mg/kg N = 75 TB‑402 0.6 mg/kg N = 74 TB‑402 1.2 mg/kg N = 87 Enoxaparin 40 mg N = 79