Replies to post #75297 on Innovation Pharmaceuticals Inc (IPIX)

[cabel]

We don't have the data for that (yet). All we know is B met the primary endpoint and was the statistical equal of Daptomycin at that point. Unless someone knows something I don't, your question cannot be answered until more information is available.

A single dose regimen has been selected for phase 3 and plans are being made to move forward. We also know from an earlier PR that all 4 arms combined had a better response at 7 days in the p2b than the p2a. While I would feel more comfortable with data in hand, it may be a while before we get to see it.

I am curious,.... these results were based on 2-3 days after dosing started, and we showed that we were not inferior to Dapto,... yet one of our arms plus the Dapto arm were not even finished dosing at that time.

On top of that, Leo announces plans to use the one day dose for Phase 3, without releasing to us the data results for 7, 10, and 28 days.

Perhaps it is Leo's way of saying,... wink, wink, nod, nod!! We know the results of the 7, 10, and 28 days,...?

[TheHound]

"B met the primary endpoint and was the statistical equal of Daptomycin at that point."

I don't think B was compared to D at the primary endpoint...

[loanranger]

"All we know is B met the primary endpoint and was the statistical equal of Daptomycin at that point."

If that's true, and given that there were 4 or 5 days of daptomycin treatments left to administer, then isn't this jumping the gun a bit?
"This is an historic event"

and isn't this basically false?
"....we have proven the efficacy of one dose of our novel drug Brilacidin to be comparable to seven days of therapy with the blockbuster antibiotic daptomycin to treat ABSSSI with zero drug-related SAEs,"
Remember the criteria:
"... defined as reduction of at least 20% in area of ABSSSI lesion, relative to baseline, when observed 48-72 hours after the first dose of study drug..."
However, if the "study drug" is defined in the above statement as B only and in fact the daptomycin result was measured 48-72 hours after the LAST of the 7 daptomycin treatments, everything is as rosy as suggested. If that's the case I'll withdraw my comments, but the PR seems fuzzy on the point.


As far as I can tell...and this is the same question...am I wrong in my understanding that one (or two) doses of Brilacidin is as effective as the first two (or three) days of therapy with daptomycin?


Maybe this is an easier way to ask it, although I think it loads the question: Is it your understanding we are being told that there was a reduction of at least 20% in area of ABSSSI lesion 48-72 hours after a 7 day treatment with daptomycin? And is it your understanding that the same result was achieved 48-72 hours after a single dose of B?