Allphase Pharma Consulting, LLC
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We have often mentioned the central importance of microbiological response as an endpoint in trials of antibacterials. This is contrary to other therapeutic areas, in which the etiology is less understood and where surrogate markers are needed. In bacterial infectious Continue reading Microbiological Response as Primary Efficacy Endpoint for Antibacterials
It started all so well with fanfare and great expectations. Fifteen years ago, the 10 x ’20 initiative got underway. Its goals were spelled out clearly: To ‘Pursue a Global Commitment to Develop 10 New Antibacterial Drugs by 2020 ’[3]. It Continue reading The 10 x ’20 Initiative – A Retrospective
Sulopenem / ORLYNVAH approved for uUTI When Iterum, a Pfizer spin-off of sorts, took over sulopenem development in 2015, there was still hope for approvals of this drug in multiple indications such as uUTI, cUTI, cIAI and even CABP. Ten Continue reading Sulopenem uUTI – Does It Suffice?
GSK’s pipeline in anti-infectives is impressive. It comprises drugs for bacterial, mycobacterial, fungal, viral infections, and for malaria; in addition, they have a number of vaccines in development. Several antibiotics are listed on their website targeting UTI pathogens, and one Continue reading BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1
Study Design in ABSSSI – A Statistician’s Delight The design of the O’Riordan ABSSI study [1] deserves comment. This was a double-blind study of 2 lower dose arms (Part 1) with an add-on open-label (Part 2) high-dose arm. The pimary Continue reading Gepotidacin ABSSSI – How to Fail Adaptively