Ann: Positive interim analysis of DMX-200 phase II data-DXB.AX, page-123

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rocco

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17/10/16

16:51

Post #: 19915529
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Originally posted by Ahmed ↑

amirbang,

Understand your sentiments, but I want to comment on a couple of things, if not for you - for the benefit of others on this forum..

"significant reduction"- 3/11 showed a phenomenal reduction! 50% or more when you are already stabilised on irbesartan is a truly amazing result. The 2nd patient who continues on the drug after the trial had a reduction less than 50% and was deemed clinically significant by virtue of continuing on treatment through SAS. Part of the confusion here (and the company has contributed to it somewhat) is in the question.. what is a significant result? Chemocentryx stated 20% or more is great! DXB set the bar super high at 50% and by doing so - have led people to believe that a reduction less than that, even 25-30% is not significant. This is NOT true! Ring your nearest tertiary hospital and ask to speak to the Nephrologist or renal registrar on call (hopefully when they're not too busy) and ask them if a reduction in proteinuria of 25% when a patient is already stabilised on irbesartan is significant (good) or not!

The market needs to be educated here.

"statistically significant"- this was a phase 2a dose-escalation study primarily designed to evaluate safety of the combination in this patient population- not powered to detect a statistically significant difference in efficacy. So a signal in efficacy would be a positive here, and we saw a very strong signal in at least three patients. Remember, patients were escalated through 5 dose levels (only 2 have completed this mind you) whereby they received one dose level for 4 weeks before progressing to the next higher level. As with most drugs, there is an optimal dose or dose range and so patients may not have stayed within this range for long enough to derive maximum benefit. This is a perfectly acceptable approach in this exploratory study. The next part, however, will test this optimal dose(s) for a longer period- here we should see an enhanced effect and it can be measured against placebo to determine statistical significance. So the fact that 3 patients had a stellar result during dose escalations is even better. Any statistically significant reduction in proteinuria over placebo which is safe has value as a novel treatment!

We are just getting started guys..

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