Biotech Values

[DewDiligence]

Re: MNTA M118 program / delayed start of phase-2b

Maybe they only made budget [in 2008] because they didn't take M118 into a p2b like they planned :)

In all seriousness, having to run a phase-2a trial in elective PCI/stable angina prior to conducting a phase-2b trial in ACS ought to have been obvious to someone who was well versed in interventional cardiology. The problem is that, prior to the hiring of James Roach as CMO in early 2008, MNTA did not have such a person on staff. I consider this one of MNTA’s few outright mistakes, but the deficiency was promptly rectified with Roach’s hiring. (See #msg-27338039 for Roach’s impressive résumé).

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For the benefit of readers who may not know the rationale for the M118 course correction and the need for a phase-2a trial in elective PCI/stable angina, I’m reposting the following excerpt from #msg-26809439:

When a patient with Acute Coronary Syndrome (ACS) presents at a hospital with symptoms that suggest an MI, the first order of business is determining if the situation warrants: i) open surgery; ii) PCI (a stent placement in the cath lab); or iii) treatment with drugs only (“medical management”).

However, there are medical benefits to administering an anticoagulant immediately—even before determining which of these three subgroups a given patient belongs to. Therefore, for clinicians to be comfortable with giving an experimental drug such as M118 during the ACS intake period, they must be confident that the drug is suitable for all three of the subgroups described above.

It follows that, from an ethical and practical standpoint, testing M118 in PCI is a prerequisite for testing it in the ACS-intake setting. MNTA came to this realization after speaking with cardiologists who told the company they would not participate in a [phase-2b] M118 trial in the ACS-intake setting until MNTA completed a successful [phase-2a] trial in PCI.