Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?
INSMED – NTM The company that is developing Arikayce, a preparation of liposomal amikacin inhalation (LAI), for the treatment of NTM had to withdraw its MAA in Europe earlier this year  because data was not convincing enough for regulators to Continue reading Aerosolized Antibiotics (Part 2) – Mixed News on Two Fronts
There is much interest in inhaled antibiotics these days. Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy Continue reading Antibiotic Inhalers Galore (Part 1): More Combinations and Permutations than a Rubik’s Cube
Here an updated listing of all QIDP drugs we are aware of as of 12/24/2015. Today just facts and numbers; we will provide an interpretation of the current landscape in upcoming blogs. There are 58 drugs which garnered QIDP status and these Continue reading QIDP Antibiotics – 2015 Year-End Update
Looking at the molecular structure of ceftazidime (CTAZ) and aztreonam (ATM), the differences are clear, and so are the similarities: ATM does not have the cephem ring structure of CTAZ, only the 4-member beta-lactam ring. However, the side chains are Continue reading Aztreonam PLUS Avibactam – A New Bright Star in the Night Sky
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)
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)
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)
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)
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?
The development history of glycopeptide drugs is anything but normal. Daptomycin (Cubicin®) was abandoned by Lilly but resurrected by Francis Tally at Cubist by adjusting the dosing schedule to once daily and careful uptitration. The drug did superbly in a Continue reading Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides