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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\u003Cp id=\u0022p-1\u0022\u003EBrilacidin is a novel host defense protein being studied for the treatment of community-acquired skin and soft tissue infections. A phase 2b trial shows that a single-dose injection of brilacidin is as effective as a 7-day dose of daptomycin in treating acute bacterial skin and skin structure infections associated with \u003Cem\u003EStaphylococcus aureus\u003C\/em\u003E.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eacute bacterial skin and skin structure infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ebrilacidin, methicillin-resistant \u003Cem\u003EStaphylococcus aureus\u003C\/em\u003E\n            \u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMRSA\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Edaptomycin\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einfectious diseases clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ebacterial infections\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003ECommunity-acquired methicillin-resistant \u003Cem\u003EStaphylococcus aureus\u003C\/em\u003E (MRSA) is a growing problem in the United States and Europe and is a major cause of acute bacterial skin and skin structure infections (ABSSSIs) among otherwise healthy people in the community. Daniel Jorgensen, MD, Cellceutix, Beverly, Massachusetts, USA, presented safety and efficacy data from a phase 2b trial that compared brilacidin (BRI) with daptomycin (DAP) in treating community-acquired ABSSSI caused by \u003Cem\u003ES aureus\u003C\/em\u003E.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EBRI is a novel synthetic mimic of host defense proteins that has shown in vitro activity against multidrug-resistant \u003Cem\u003ES aureus\u003C\/em\u003E in phase 1 and 2a trials. Antibiotics in this category, also known as \u003Cem\u003Edefensin mimetics\u003C\/em\u003E, kill bacteria in the same manner as the human immune system and thus are less likely to induce antimicrobial resistance. According to Dr Jorgensen, previously presented phase 2a data suggested that BRI was as effective as DAP over 7 days in treating ABSSSI [Jorgensen D et al. ICAAC 2012 (poster L1-1662)]. However, a transient dose-dependent elevation in blood pressure, likely the result of overdosing, was also noted. Therefore, the highest total dose of BRI used in the phase 2b trial (1.2 mg\/kg) was less than the lowest total dose (1.6 mg\/kg) used in the phase 2a trial.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe phase 2B trial included 215 patients in the United States with an ABSSSI as defined by the FDA [FDA. \u003Cem\u003EGuidance for Industry\u003C\/em\u003E. 2013]. Patients were randomized to 1 of 3 BRI injections: low (0.6 mg\/kg, single dose), medium (0.8 mg\/kg, single dose), or high (0.6 mg\/kg on day 1 and 0.3 mg\/kg on days 2 and 3). The comparator was DAP (4 mg\/kg) for 7 days. The primary end point was early clinical response (48 to 72 hours). Clinical response was defined as a percentage reduction in lesion size \u2265\u200520% compared to baseline.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe US clinical response rates are shown in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/16610\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/16610\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16610\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EClinical Response Rates: All-Treated Population\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-12\u0022\u003EAccording to Dr Jorgensen, there was an early and sustained percentage change in lesion area from baseline to day 7 and again through short-term follow-up (days 10 to 14) in both the all-treated\/safety population and the microbiological intent-to-treat population. The most commonly isolated pathogen was \u003Cem\u003ES aureus\u003C\/em\u003E, including MRSA. Safety data suggested that patients who received BRI were more likely to experience mild and transient numbness or tingling as compared with the DAP group; however, no increase in hypertension was noted in those randomized to BRI, and no deaths in any group were reported.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EIn conclusion, Dr Jorgenson emphasized that BRI appears to offer high activity against MRSA. A single dose was safe and effective when compared to a 7-day dose of DAP for the treatment of ABSSSI, which might offer treatment, pharmacoeconomic, and compliance advantages to health care providers and patients.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/48\/11.2.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzllxf\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzllxf\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}