Thanks for that comprehensive recap and reply MozzI am also...

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goldmad

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05/07/23

09:11

Post #: 68624523
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Originally posted by Mozzarc: ↑

Yes I seem to recollect that it was the FDA that wanted us to try smaller doing rather than 2 mg/kg twice a week.

From what I know it will be one of the three doses in the current 002 dosing arm (Part 1) that we will use in the P3 including confirmatory.

As you stated, the dosing regime in 008 is slightly different:

Lets have a look as a recap:

002 Program as stated today:

• 1.5 mg/kg calculated for ideal body weight (IBW) iPPS twice weekly,
• 2 mg/kg IBW iPPS once weekly + placebo once weekly,
• Fixed doses
100 mg iPPS for ≤65 kg IBW once weekly + placebo once weekly, or
150 mg iPPS for >65 to ≤90 kg IBW once weekly + placebo once weekly,
or
180 mg iPPS for >90 kg IBW once weekly + placebo once weekly
• Placebo twice weekly

008

• PPS twice weekly: 2.0 mg/kg IBW PPS twice weekly for 6 weeks
• PPS once weekly: 2.0 mg/kg IBW PPS once weekly + placebo (0.9% saline) once weekly for 6 weeks
• Placebo: placebo (0.9% saline) twice weekly for 6 weeks

I agree with Zenox's analysis and I also am not sure at what point the DMC would recommend the case if our drug shows exemplarily efficacy (and assumed top notch [pristine] safety profile). There are plenty of points and words in the legislation if the drug doesn't have a good safety profile so getting the nod of status quo and to proceed bodes very well for us of course from the DMC's point of view.

There are words in the legislation that support this case of a drug working very well but perhaps it makes sense once the dosing is finally determined to begin discussions along this path, no doubt a point to be tabled when we officially meet the FDA/EMA later this year?

Goldmad also in my opinion, don't forget that once the dose is determined, there is still some flexibility that the retreatment and durational studies will be accreditive in terms of data and ultimately deciding what recommendations are in place. It may very well turn out that the initial course of the drug is one dose, but the retreatment (boosters) may be another.

The three doses are effectively in weekly terms 2mg, 3mg and 4mg. 4 being ruled out (ie 2 x 2)...it seems logical that 1.5 x 2 would be the sweet spot in this case and would still be somewhere at the upper segment of the bell curve in terms of efficacy?

Finally, it would still be a very arduous process in my view if the 1.5 x 2 weekly dosing proves to be ineffective, I don't for a sec think this will be the case in my personal opinion. You'd think the FDA would have to be considerate in this rare case as it was their recommendation and sanctioning of the lower dosing regime in Part 1 of 002.

There have been a number of cases of SubQ PPS with as little as one injection of 2mg for only three weeks resulting in significant pain relief. I personally know of one guy that got only 4 injections and had to stop but still also got a meaningful pain reduction and was very happy with the result. Yes these are only a handful of examples but my point is that 1.5 x twice a week is fairly close to 2 x 2mg at the end of the day.

I guess we wait and see!

DYOR

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Thanks for that comprehensive recap and reply Mozz

I am also fairly confident based on past studies that the 1.5x2 will get the job done but it is also my biggest fear of what could go wrong.

We have years of real world data on the 2x2 dose and its effectiveness and right at the finish line we are trying a new dose for the final trials.

PAR Price at posting: $1.03 Sentiment: Hold Disclosure: Held
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