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Thanks Mozz, that does help me better understand what we know...

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RTheo

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22/03/24

12:15

Post #: 73011912
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Originally posted by Mozzarc: ↑

RTheo - It's actually a more complex question to answer as there are bits and pieces of research over time that have led to my conclusion.

One small example is the polydiversity of the molecule, it tends to be closer to 1.0 as you approach the peak of the bell curve.
This allows for a more consistent molecule and another result is the affinity/binding properties between TIMPS and ADAMTS-5 as an example.

Yeah it gets a bit technical. There are a few examples of this but it has been observed that the best efficacy for iPPS appears to be circa 2mg/kg.

Another example are non direct addressing of certain phenotypes, ne that comes to mind is the comparison they did with mice on a Rotarod, the best improvement again was at that 2 mg level...

We also got good results in the RRV trial which was at the 2mg/kg dosing.

See this link: https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-021-04123-w

Here is another example of a dosing study of iPPS in rats:

So my take is that the pioneers of iPPS all used around the 2mg/kg dose. I suggest if you increase it slightly (but perhaps decrease the dosing frequency, or the other way around), the net effect is prob similar to a point. Its governed by a bell curve so the drop off on either side could be noteable. I've read a number of times that it is the intermittent dosing and relationship of half life of the molecule that adds to the magic and how and when best it works.

One could get a bit hung up on the exact best point of efficacy in a general cohort but at the end of the day we seem to have the best success at these levels without jeopardising safety (SAE's).

m931392 - We are currently in the process of putting in a revised protocol as Paul stated yesterday. This infers that there is no question of Clinical Hold.

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Thanks Mozz, that does help me better understand what we know about optimal dosing. But I'm still at a loss to reconcile the placebo vs 1mg/kg result.

PAR Price at posting: 36.0¢ Sentiment: Hold Disclosure: Held
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