TXA-709 –  New Kid on the Block

When searching for FtsZ inhibitors on PubMed, there are 187 hits. When narrowing down the search looking for clinical trials only, there are none. Taxis Pharmaceuticals obtained QIDP status for its candidate drug TXA-709 in late 2016 and it is Continue reading TXA-709 –  New Kid on the Block

Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

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

QIDP Drug Update – Part 1: An Updated Who Is Who

It is time for a new look at the field of QIDP drugs. Today we are providing an updated searchable database which now has 57 entries. (Status: 10/18/16) Despite best efforts to provide accurate information, errors may have crept in. Please let us Continue reading QIDP Drug Update – Part 1: An Updated Who Is Who

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

Quo Vadis, CDI Drugs?

There are only 3 CDI drugs in wider clinical use: vancomycin, metronidazole, and fidaxomicin. They are from totally different classes and have almost nothing in common except for proven efficacy in C. difficile infection (CDI). Like vancomycin, the entire group Continue reading Quo Vadis, CDI Drugs?

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)

Dalbavancin Approval Issues: A Case of Much Ado About Nothing

Dalbavancin has changed hands a few times in its development history, moving from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004.  Pfizer acquired dalbavancin as a “Phase 3 completed” Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing

Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

It is no secret that most existing antibiotic guidelines are not getting much use these days.  The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP.  Yes, the occasional HABP/VABP trial is Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

Streptomyces – The Industrious Antibiotic Producer

Like other actinomycetes, the Streptomyces group of microbes straddles the somewhat artificial boundary between bacteria and fungi. Growth on culture plates looks ‘fungal’ and the organism produces spores and germtubes that look like mycelia.  Nonetheless these soil organisms are bacteria and of Continue reading Streptomyces – The Industrious Antibiotic Producer

Brilacidin – QIDP Drug At a Critical Juncture

At around this time (July 2015), Cellceutix is expected to hammer out a Phase 3 program for brilacidin, its defensin-mimetic and host-defense protein (HDP) mimic structurally similar to magainin, with FDA. Brilacidin is certainly an interesting novel compound, coming from a Continue reading Brilacidin – QIDP Drug At a Critical Juncture

Vancomycin vs TMP/SMX for MRSA – Not the Final Word

Vancomycin got a bad reputation since the early 90ies when it became clear that it was slow to provide clinical improvement and microbiologic cure in MRSA patients.  It was associated with prolonged bacteremia even when combined with rifampin [1].  And for MSSA, Continue reading Vancomycin vs TMP/SMX for MRSA – Not the Final Word

No Such Thing as a Free Ride…

..when it comes to FDA review of antibiotic NDAs.  Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.  Many failed not because of lack of efficacy Continue reading No Such Thing as a Free Ride…

Why Some Did Not Make It

There are numerous reasons why drugs get stuck in development.  Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well.  For instance regulatory issues or manufacturing, difficulties can stop a program.  Continue reading Why Some Did Not Make It

Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k

Looking at all antibiotics in the pipeline, I can’t help but think that – by 2018 – there will be some blockbuster anti-infectives coming to the market. Why do I say this?  What is going to generate this revenue stream for companies Continue reading Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k

Adequate Penetration of Daptomycin Into Bone Tissue

After a single high dose of (8 or 10 mg/kg BW) of daptomycin IV, bone levels were measured in plasma and trabecular bone obtained during hip or knee surgery of 16 patients.[1] At the time of surgery, mean concentrations in Continue reading Adequate Penetration of Daptomycin Into Bone Tissue