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Posted On: 05/03/2022 5:27:18 PM
Post# of 72446
Old but interesting-
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3854692/
Also interesting in consideration of the difficulty and cost related to getting a new antibiotic to market-
In July 2015, Cellceutix reported the outcome of a successful End-of-Phase 2 Meeting with the FDA, during which the agency provided input on the Company's proposed phase 3 program. This meeting was a significant milestone for Cellceutix and it triggered the start of phase 3 activities. An agreement was reached in conducting two randomized, well-controlled phase 3 non-inferiority studies, comparing Brilacidin to an approved ABSSSI regimen, with an interim analysis as part of the first study. In addition, and in part related to the novelty of Brilacidin as a completely new class of antibiotic, the FDA requested additional information before the start of the first phase 3 study. Cellceutix is pleased to announce that it has completed this research, compiled the requested information and is submitting it, along with the final protocol for the clinical studies, in the request for a SPA.
How could recent reports of Daptomycin showing decreasing effectiveness relate to this? Is it possible that higher interest might be present in pursuing this now?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3854692/
Also interesting in consideration of the difficulty and cost related to getting a new antibiotic to market-
In July 2015, Cellceutix reported the outcome of a successful End-of-Phase 2 Meeting with the FDA, during which the agency provided input on the Company's proposed phase 3 program. This meeting was a significant milestone for Cellceutix and it triggered the start of phase 3 activities. An agreement was reached in conducting two randomized, well-controlled phase 3 non-inferiority studies, comparing Brilacidin to an approved ABSSSI regimen, with an interim analysis as part of the first study. In addition, and in part related to the novelty of Brilacidin as a completely new class of antibiotic, the FDA requested additional information before the start of the first phase 3 study. Cellceutix is pleased to announce that it has completed this research, compiled the requested information and is submitting it, along with the final protocol for the clinical studies, in the request for a SPA.
How could recent reports of Daptomycin showing decreasing effectiveness relate to this? Is it possible that higher interest might be present in pursuing this now?
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