I wonder why Leo didn't give us a PR like he did when B 2b concluded? Both trials had 3 treatment arms and 1 control arm. He knew then. You would think he'd know now.
The initial results from the study are general observations and only considered blinded data averaged across all four treatment groups. Similar to a previously conducted Phase 2a study, Staphylococcus aureus (including MRSA) was the most common bacteria isolated at the baseline visit. The data shows that by Day 7, the average cure rate for all four treatment arms was higher than what was observed in the phase 2a study, and similar to – if not higher than – cure rates reported for common ABSSSI drugs, as well as those approved this year. Because 3/4 of the patients in this study were treated with Brilacidin, this high average cure rate is heavily influenced by Brilacidin, and less influenced by daptomycin, which only 1/4 patients received. This also means that the two single-dose treatment arms are providing half of the data toward this positive average cure rate; and if these data hold up, a single-dose regimen of Brilacidin would be the Company’s Phase 3 study design.
Cellceutix will not know the actual cure rates per treatment arm until the data is unblinded in October/November. However, the Company is very optimistic and views the high average cure rate on the blinded data as a very good sign for Brilacidin. Assuming positive results after unblinding, Cellceutix will have proven that Brilacidin is a safe and effective drug in the Phase 2 trial, and all activities will be triggered for initiation of a pivotal Phase 3 trial.
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