There was never any real doubt that M118 would work as well as heparin in this indication; the only question was whether some bizarre safety problem would turn up, although this was unlikely inasmuch as M118 is derived from heparin.
Now that M118 has succeeded in showing comparable safety and efficacy to heparin in PCI, MNTA can ink a partnership deal and the partner can proceed to a phase-2b trial in ACS.
Not much that we don’t already know, IMO. From MNTA’s PR on 6/29/09 (#msg-39142514) and Craig Wheeler’s comments on a recent webcast, we can infer the following:
1. Each of the three M118 arms in the phase-2a trial was numerically better than the heparin control arm on the composite* primary endpoint.
2. The trial was too small for a finding of statsig non-inferiority relative to the heparin control arm for any individual M118 arm or for the three M118 arms combined. This is not surprising; a finding of statsig non-inferiority relative to an approved comparator drug (heparin in this case) generally requires a larger trial than a finding of statsig superiority relative to a placebo comparator. It was not necessary or desirable for MNTA to conduct such a large trial on its own dime.
3. The phase-2a trial accomplished its main goal of showing that M118 can be used in the PCI subset of the ACS indication. This will enable MNTA’s partner-to-be to run one or more large phase-2b trials in ACS per se. (Please see the discussion in #msg-37693105 for background.).
*The primary endpoint was a composite of these seven 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.
Market Data 
Markets 
AI
