Replies to post #109676 on Biotech Values

[dewophile]

In the M118 EMINENCE study, the lowest-dose arm (50 IU/kg) paradoxically had the best efficacy (#msg-48837450, #msg-48837695), which is why I’m pretty sure MNTA will advance this dose into phase-2b

if you exclude bleeding (i.e use a primary endpoint such as you suggest in a subsequent study) the 50 arm did worse than the other M118 arms or UH on major endpoints, including a composite such as you suggest as the primary endpoint in a subsequent study. so the difference between the primary endpoint in eminence is almost entirely due to minor bleeding - something that can be controlled more carefully for with more vigilent catheter site management and level of anticoagulation (in fact the authors point out that due to difference in the relative Xa/IIa inhibition of M118 vs UH the degree of clinical anticoagulation is greater for M118 than for UH when monitoring ACT - something that was not accounted for in eminence

from table 4 of the paper (from left to right cohorts are UH, M11850, M11875, m118100):



Death or MI 9/151 (6.0) 5/44 (11.4) 10/152 (6.6) 9/156 (5.8) 24/352 (6.8)
Death, MI, or repeat revascularization 13/151 (8.6) 5/44 (11.4) 12/152 (7.9) 10/156 (6.4) 27/352 (7.7)
Death, MI, repeat revascularization, or major bleeding* 13/151 (8.6) 5/44 (11.4) 13/152 (8.6) 12/156 (7.7) 30/352 (8.5)