Drug Overview
Delafloxacin is a novel broad-spectrum fluoroquinolone that prevents bacterial DNA synthesis through its equal inhibitory effect against the enzymes topoisomerase II (DNA gyrase) and IV. The drug’s weak acid character enables it to demonstrate enhanced potency within the acidic environment of infection sites in contrast to most other fluoroquinolones. Delafloxacin has potency against quinolone-resistant Gram-positive and Gram-negative bacterial strains. It has also shown efficacy against methicillin-resistant Staphylococcus aureus (MRSA) including strains resistant to previous quinolones.
Analyst Outlook
Delafloxacin is a broad-spectrum fluoroquinolone antibacterial in Phase III development for acute bacterial skin and skin structure infections (ABSSSI) by Melinta Therapeutics. The company initiated Phase III development of the drug in 2013 after it met its Phase II primary and secondary endpoints. Melinta’s small size represents a commercial limitation to delafloxacin in the ABSSSI market, at least in the absence of larger partners with stronger commercial and marketing resources. From a clinical aspect, the negative safety perception of fluoroquinolones will pose a hurdle to delafloxacin’s clinical uptake.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 delafloxacin : Skin and skin structure infections
LIST OF FIGURES
10 Figure 1: Top-line Phase IIb results for delafloxacin in ABSSSI
12 Figure 2: Phase IIb results for delafloxacin in ABSSSI
13 Figure 3: Delafloxacin’s SWOT analysis in cSSSI
13 Figure 4: Datamonitor Healthcare’s drug assessment summary of delafloxacin in cSSSI
14 Figure 5: Datamonitor Healthcare’s drug assessment summary for delafloxacin in cSSSI
LIST OF TABLES
4 Table 1: Delafloxacin’s drug profile in ABSSSI
8 Table 2: Clinical development of delafloxacin in ABSSSI