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Replies to post #250798 on Innovation Pharmaceuticals Inc (IPIX)
12/09/18 5:08 PM
12/09/18 6:45 PM
Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the body's innate immune system, it is a synthetic, non-peptidic small molecule that kills pathogens swiftly, significantly reducing the likelihood of drug resistance developing. Just as importantly, Brilacidin functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing.
“Low cytotoxicity of brilacidin and its analogs versus mammalian cells in metabolic activity and hemolysis assays, and efficacy in mouse tissue infection models following IV administration were important qualifications for entering clinical studies as a systemic IV antibiotic. Brilacidin has completed several Phase 1 and two Phase 2 clinical studies for ABSSSI. Brilacidin displayed predictable pharmacokinetic properties with a half-life of approximately 17 hours following IV administration [91]. In the first Phase 2A ABSSSI trial, brilacidin was administered IV once daily for 5 days at three dosages with approximately 50 patients per dosage arm (www.clinicaltrials.gov; NCT01211470). The active comparator was daptomycin administered IV once daily for 7 days according to label instructions. Clinical response rates in all analysis populations were high across all three dose groups and similar to daptomycin [92]. The most common side effect was paraesthesia and hypoaesthesia (numbness and tingling) that resolved quickly after treatment cessation. Infrequent increases in blood pressure and heart rate that were rapidly reversible were also observed and appeared to be dose-related. A Phase 2B trail in ABSSSI for dose optimization has been completed (www.clinicaltrials.gov; NCT02052388) and results were reported at the 2015 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) conference in Copenhagen, Denmark [93]. The trial included 2 single dose arms of brilacidin (0.6 and 0.8 mg/kg IV) with the positive control comparator, daptomycin administered IV once daily for 7 days. Single dose brilacidin was safe and well-tolerated. Efficacy was high in both regimens at the early Food and Drug Administration (FDA) timepoint (day 2 -3) indicating an immediate response and high at later timepoints (day 7-8 and 10-14) indicating a sustained clinical response. Efficacy was also similar to 7 days of treatment with daptomycin. There were no treatment-related serious adverse events (SAEs) or cardiovascular SAEs and blood pressure events were low in the 0.6 mg/kg single-dose regimen, similar to or better than daptomycin, an antibiotic with no reported blood pressure effects. Numbness and tingling was reported in both single dose regimens but were mild and transient. A phase 3 trial is currently being planned.
Given the broad activity profiles of these smHDPs with anti-bacterial, -fungal, and –parasitic action, including agents with activity across this spectrum, or agents with potent but select antimicrobial activity in one category, the future looks incredibility bright for their continued development. Additionally, rapid improvement in oral bioavailability despite the limited research effort due to the program size, suggests smHDP designs hold considerable promise. Two additional areas of serious need and opportunity include improved Gram-negative activity (especially in vivo) and understanding (as well as exploiting) their immune-modulatory activity.”
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