Replies to post #93956 on Biotech Values

[DewDiligence]

What Are MNTA’s Goals for M118?

As shown in #msg-48837450, the phase-2a EMINENCE study found M118 to be non-inferior to unfractionated heparin (UFH) in PCI (stent implantation) in a relatively low-risk patient pool. This is nice, but MNTA is presumably expecting much more from M118 than mere non-inferiority to an existing drug.

In a larger and longer phase-2b trial, MNTA’s goal will presumably be to show that M118 is superior to a SoC comparator (UFH, Lovenox, or Angiomax) in a medium- or high-risk patient pool in ACS.

Note that ACS, rather than PCI, has always been the intended indication for M118. The phase-2a trial in PCI was run because MNTA had to do it, not because they wanted to do it (#msg-26809439).

[DewDiligence]

M118: Kaplan-Meier Plot of Primary Endpoint in EMINENCE Study

Note: the y-axis is the probability of averting a bad outcome;
thus, higher numbers are better in this graph.



The primary endpoint in the EMINENCE study was the mathematical
set union operation applied to these seven binary variables:

• Death during the 30 days post PCI procedure;
• Non-fatal MI during the 30 days post PCI procedure;
• Non-fatal stroke during the 30 days post PCI procedure;
• Repeat PCI during the 30 days post PCI procedure;
• Major bleeding during the 24 hours post PCI procedure;
• Thrombocytopenia during the 24 hours post PCI procedure; and
• Bailout use of a GP IIb/IIIa antiplatelet drug during the PCI procedure.

[DewDiligence]

Biostatistics quiz (medium difficulty): The statistical requirement for the finding of non-inferiority in the M118 EMINENCE study (#msg-48837450) turned out to be considerably more stringent than the trial designers and the FDA expected. How so?