Replies to post #75309 on Innovation Pharmaceuticals Inc (IPIX)

[noretreat]

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?

Yes...that is what we know from the latest PR. I think it is safe to say that B is the statistical equal of D after 7 days as well....from the earlier pr. We know that because the p2a had just under 90% effectiveness for all arms combined. We also know that the results were better in the p2b. Even if D performed better this time, statistical equality with sample sizes of 50 is a pretty broad range. It is a certainty that at least one B arm is in that range, and almost a certainty that all 3 arms are in that range. When the statistical ranges narrow with the larger sample in p3, B will need to be close to D. That is why it would be nice to see the data sometime soon. The details are coming for sure in April (I think that is what the pr said), but of course I would like to have had them "yesterday".

I can't answer any of the other questions because I don't know the answer. More will be revealed...I think this one requires a little patience.

But everyone makes their own investment decisions.

[biodoc]

loanranger, the answer to your first question is no. Your second question is comparing two different timeframes and really isn't relevant to the discussion.

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?

The primary endpoint is reduction of lesion size by 20% or more 48-72 hours after starting antibiotic therapy- NOT after completion of the antibiotic regimen. The duration of the antibiotic regimen is not relevant to this primary endpoint.

The press release from 10/23 CLEARLY states primary endpoints were met for all three Brilacidin arms:

The primary endpoint was clinical success in the intent-to-treat population, 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, and no rescue antibiotics administered.

All three Brilacidin treatment arms (two single-dose regimens and one three-day dose regimen) reached the primary endpoint, with the clinical success rate for each dosing regimen statistically comparable to the clinical success rate of the FDA-approved seven-day dosing regimen of daptomycin.

Brilacidin's relatively long half-life and sub-MIC activity allows a single appropriately sized dose to clear the infection.

[muelch]

Just to touch on one more thing here as I think the importance of the fact that we met the primary endpoint has already been highlighted.

The secondary endpoints are still important. I see three possibilities:
1. We met the primary endpoints
2. We didn't meet the primary endpoints
3. Cellceutix doesn't know if we met the primary endpoints yet and they were too excited to announce that we met the primary endpoint to wait

I think #3 is the most likely, especially given that this was our first efficacy results I can forgive the lack of detail, so long as there are no surprises.