Kyle Kimme

BioMS: Hype or Hope?

Thank you very much for your insight Richard. It is much appreciated.

BioMS: Hype or Hope?

Richard,

Thanks for the quick response. Maybe I don't fully comprehend the science, but I am having difficulty with the logic. I understand where your coming from regarding Dirucotide not having an affect on relapses and MRI activity for RRMS patients (MINDSET-01), so it seems reasonable to assume it will not have an affect on SPMS either (unless there is another non-inflammatory mechanism that is more specific to SPMS as you mentioned).

However, using the same logic, isn't it reasonable to assume that since Dirucotide had a positive affect on the EDSS and MSFC scores for RRMS patients, that it will also have a positive affect on SPMS patients?

If so, wouldn't it be reasonable to assume that the Phase III test for MAESTRO-01 will be successful in that it's primary and secondary end points relate to the EDSS and MSFC scores?

Also, I'm not sure how the process works, but when a patient completes the trial period, are they told if they were on the placebo or the drug? What I'm trying to get at is, of the 95% patients that enrolled in MAESTRO-02 trials, would they have known if they were on the placebo or Dirucotide during MAESTRO-01 or would they have not known and just elected to enroll since there wasn't any negative side effects?

Any insight would be much appreciated.

Thanks again,

Kyle

BioMS: Hype or Hope?

Richard -

If I'm reading correctly, it sounds as though you believe MAESTRO-01 will fail to meet its primary end point based on the fact that the Phase II results for MINDSET-01 did not meet its primary end points. As you know, the primary end points for MINDSET-01 was three fold: 1) Reduce the rate of relapses, 2) Reduce MRI activity, and 3) Slow disease progression. Per the Phase II results, Dirucotide did not succeed in meeting these goals.

However, what you are not discussing is the fact that certain secondary end points for MINDSET-01 were met, including positive changes in the Expanded Disability Status Scale ("EDSS") and the Multiple Sclerosis Functional Composite ("MSFC") score.

MAESTRO-01 is primarily for non-relapsing SPMS. As such, the primary end goal for MAESTRO-01 is NOT to slow relapses or reduce MRI measures, but to improve/stabilize the EDSS for patients with SPMS. The secondary end goal for MAESTRO-01 is to improve the MSFC score for patients with SPMS.

Given Dirucotide proved successful in regards to both the EDSS and MSFC score for patients with RRMS in the MINDSET-01 trials, I believe that is a very encouraging sign that MAESTRO-01 will in fact reach its primary AND secondary endpoints (which is focused on EDSS and MSFC; not relapses, MRI activity, or growth progression).

Could you please provide me your thoughts on this? I would appreciate any thoughts you may have on this matter.

Thank you,

Kyle