Replies to post #93800 on Biotech Values

[DewDiligence]

MNTA:

“The primary end point occurred in 31.1% of patients randomized to UFH and in 22.7%, 28.3%, and 30.1% of patients randomized to M118 50, 75, and 100 IU/kg, respectively.”

[mcbio]: It appears that there is a pretty clear dose-response relationship with respect to M118. Is it expected that MNTA or, more likely, a partner will test M118 at doses above the 100 IU/kg level in an upcoming Phase 2b trial to see if M118 can produce even better results?

Your first sentence is incorrect—in the primary efficacy endpoint of the EMINENCE study, lower numbers are better; thus, the EMINENCE study did not find a relationship between dose and efficacy.

Note also that the lowest-dose M118 arm, 50 IU/kg, was discontinued in Sep 2008 (#msg-32382532), resulting in fewer patients being enrolled in this arm (n=44) than in the 75 IU/kg M118 arm (n=152), the 100 IU/kg M118 arm (n=156), and the UFH control arm (n=151): #msg-41846746. The seemingly better performance of the 50 IU/kg arm on the primary efficacy endpoint was just statistical noise caused by the truncated sample size of this arm.

As to your question on whether the phase-2b trial in ACS will test a higher dose of M118 than 100 IU/kg, the answer is maybe. If the design were up to me, I would probably include at least one arm higher than 100 IU/kg for the sake of completeness, although I would not necessarily expect such an arm to outperform the 75 IU/kg and 100 IU/kg doses.