Aradigm Lost in ORBIT – Hayward, We Have a Problem

It is interesting to see how often a discussion of study results moves from microbiology to clinical significance to statistical analysis details. When an antibiotic is not evaluated on the basis of its antimicrobial activity but on its ability to Continue reading Aradigm Lost in ORBIT – Hayward, We Have a Problem

Progress Report: New Antibacterials In the Fight against MDR Bacteria

Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria

Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

Roche’s current Phase 2 program is strangely ambiguous.  RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed.  An uncontrolled open label study in “patients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment” Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 1)

When Roche inlicensed Polyphor’s anti-pseudomonas drug POL7080 in November 2013, it marked a turning point.  It seemed that Big Pharma that had all but abandoned the field in the last decade and was getting engaged in anti-infectives again.  When a Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 1)

Clinical Biofilm Studies – An Interesting Evolving Landscape

A recent article on “Agents that Prevent Biofilm Formation” captured my interest[1].  The authors reviewed the literature and mentioned many substances which have shown in-vitro efficacy in disrupting biofilm production by the main offenders, i.e., S. aureus, S. epidermidis, P. Continue reading Clinical Biofilm Studies – An Interesting Evolving Landscape

The Demise of KB001 (Part 2): An Anti-Pseudomonas Antibody Hits the Dust (instead of Paydirt)

FOR PART 1, CLICK HERE Should we assume that the results of this Global Epi Study were the reason why Sanofi became disillusioned about the prospects of KB001?  Or was it an internal strategic decision based on portfolio-review where KB001 just Continue reading The Demise of KB001 (Part 2): An Anti-Pseudomonas Antibody Hits the Dust (instead of Paydirt)

The Demise of KB001 (Part 1): An Anti-Pseudomonas Antibody Hits the Dust (Instead of Paydirt)

In January this year, Kalobios informed investors that KB001-A had failed to meet efficacy criteria in a Phase 2 trial of cystic fibrosis (CF) patients.  In this well-controlled well-executed placebo-controlled trial of182 patients, the primary endpoint and just about every Continue reading The Demise of KB001 (Part 1): An Anti-Pseudomonas Antibody Hits the Dust (Instead of Paydirt)

A Renaissance for Old Drugs: Fosfomycin and Colistin

Fosfomycin Who would have thought that a drug that has been around since 1969 [2] could become eligible for QIDP status in 2015? Well, Zavante Therapeutics recently garnered the coveted QIDP designation for fosfomycin IV. This formulation has been available Continue reading A Renaissance for Old Drugs: Fosfomycin and Colistin

Why Did PK/PD Modeling Fail Doripenem in VAP?

When imipenem is dosed at 1 g q8h for serious infections, it is infused over 40-60 min. Its label states that it is indicated for “lower RTI”, an old-fashioned term from the days when bronchitis and pneumonias were still lumped Continue reading Why Did PK/PD Modeling Fail Doripenem in VAP?

Learning from Set-Backs: The Frustrating Search for a Staphylococcal Vaccine

Several reasons have been proposed as explanations why so many S. aureus vaccines have failed in clinical trials.  Clearly, the organism has a battery of virulence factors which may require a multipronged approach and neutralizing just a single mechanism with a specific mAb Continue reading Learning from Set-Backs: The Frustrating Search for a Staphylococcal Vaccine

What is the “Niche” for Ceftolozane / Tazobactam?

There are currently a total of 6 beta-lactam + beta-lactamase inhibitor combinations in clinical trials. It will be a steep learning curve for the pharma reps (and physicians) to understand the resistance classifications, the confusing ESBL definitions, the CRE nomenclature, Continue reading What is the “Niche” for Ceftolozane / Tazobactam?

Fighting P. aeruginosa (Part II)

At a still earlier stage of development, we found some exciting anti-pseudomonal compounds. First, there is BAL-30072, a sulfactam-derivative.  It has an interesting dual MoA as it works not only as a traditional B-lactam but also as an Fe-chelator blocking bacteria from Continue reading Fighting P. aeruginosa (Part II)