Biotech Values

[DewDiligence]

What can investors expect from today’s M118 data?

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.