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Re: loanranger post# 75309

Saturday, 10/25/2014 6:57:44 PM

Saturday, October 25, 2014 6:57:44 PM

Post# of 402958
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.
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