Activity of Potent and Selective Host Defense Peptide Mimetics in Mouse Models of Oral Candidiasis
"These studies have shown the value of HDP mimetics as potential antifungal agents for the treatment of oral candidiasis. Compound 4 is a particularly promising compound that possesses numerous positive attributes for an oral candidiasis indication: potent and selective activity against C. albicans and NAC species, comparable activity in the presence or absence of human saliva, activity against hyphal cultures, rapid fungicidal activity, and robust efficacy in two mouse models of oral candidiasis. Fungal infections are an area of immense medical need, and the HDP mimetics offer a promising opportunity for the identification of new and effective agents for treatment of these difficult infections."
http://cellceutix.com/wp-content/uploads/2014...3820-7.pdf
Application of Pharmacokinetic-Pharmacodynamic Models for Brilacidin Dose Selection Support for Patients with Acute Bacterial Skin and Skin Structure Infections
CONCLUSIONS
• The application of PK-PD relationships to data from simulated patients allowed for discrimination among the single and three-day brilacidin dosing regimens evaluated.
• Data from simulated patients demonstrated high average predicted percent
probabilities of Sponsor-defined clinical success across the brilacidin dosing
regimens evaluated. Application of the multivariable models for safety allowed for the brilacidin dosing regimens that best balanced the need for high efficacy and good safety to be identified.
• A brilacidin 0.6 mg/kg single-dosing regimen appeared to best balance these objectives.
o This dosing regimen demonstrated a high average predicted percent probability of Sponsor-defined clinical success at TOC/STFU (88.9%), and low percent probabilities of sustained SBP ≥160 and ≥180 mmHg over 24 or 48 hours during any of Days 1 to 7 (≤1.7 and ≤0.02%, respectively).
o The percent probability of a numbness/tingling event that was moderate or severe in nature during Days 1 to 7 was 9.24%.
• These data will be useful to support selection of a brilacidin dosing regimen for evaluation in future Phase 3 studies in patients with ABSSSI.
http://cellceutix.com/wp-content/uploads/2014...tions-.pdf
Antifungal Potential of Peptide Mimetics in a Mouse Model of Invasive Candidiasis
Summary and Conclusions
➢We have identified a number of small molecule mimics of antimicrobial peptides that exhibit potent antifungal activity against C. albicans in vitro, and in vivo in a mouse model of invasive candidiasis
➢Compounds are membrane active and action is very rapid, so no resistance develops
➢These compounds show great potential for development as effective antifungal drugs to treat both topical and systemic candidiasis
http://cellceutix.com/wp-content/uploads/2014...FINAL1.pdf
"These studies have shown the value of HDP mimetics as potential antifungal agents for the treatment of oral candidiasis. Compound 4 is a particularly promising compound that possesses numerous positive attributes for an oral candidiasis indication: potent and selective activity against C. albicans and NAC species, comparable activity in the presence or absence of human saliva, activity against hyphal cultures, rapid fungicidal activity, and robust efficacy in two mouse models of oral candidiasis. Fungal infections are an area of immense medical need, and the HDP mimetics offer a promising opportunity for the identification of new and effective agents for treatment of these difficult infections."
http://cellceutix.com/wp-content/uploads/2014...3820-7.pdf
Application of Pharmacokinetic-Pharmacodynamic Models for Brilacidin Dose Selection Support for Patients with Acute Bacterial Skin and Skin Structure Infections
CONCLUSIONS
• The application of PK-PD relationships to data from simulated patients allowed for discrimination among the single and three-day brilacidin dosing regimens evaluated.
• Data from simulated patients demonstrated high average predicted percent
probabilities of Sponsor-defined clinical success across the brilacidin dosing
regimens evaluated. Application of the multivariable models for safety allowed for the brilacidin dosing regimens that best balanced the need for high efficacy and good safety to be identified.
• A brilacidin 0.6 mg/kg single-dosing regimen appeared to best balance these objectives.
o This dosing regimen demonstrated a high average predicted percent probability of Sponsor-defined clinical success at TOC/STFU (88.9%), and low percent probabilities of sustained SBP ≥160 and ≥180 mmHg over 24 or 48 hours during any of Days 1 to 7 (≤1.7 and ≤0.02%, respectively).
o The percent probability of a numbness/tingling event that was moderate or severe in nature during Days 1 to 7 was 9.24%.
• These data will be useful to support selection of a brilacidin dosing regimen for evaluation in future Phase 3 studies in patients with ABSSSI.
http://cellceutix.com/wp-content/uploads/2014...tions-.pdf
Antifungal Potential of Peptide Mimetics in a Mouse Model of Invasive Candidiasis
Summary and Conclusions
➢We have identified a number of small molecule mimics of antimicrobial peptides that exhibit potent antifungal activity against C. albicans in vitro, and in vivo in a mouse model of invasive candidiasis
➢Compounds are membrane active and action is very rapid, so no resistance develops
➢These compounds show great potential for development as effective antifungal drugs to treat both topical and systemic candidiasis
http://cellceutix.com/wp-content/uploads/2014...FINAL1.pdf
8
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