- Omadacycline’s in vivo efficacy is unaffected by tetracycline-resistance mechanisms of tetracycline-nonsusceptible pathogens from acute skin and skin structure infection (ABSSSI) and community-acquired bacterial pneumonia (CABP).
- In addition to these efficacy results from the OPTIC and OASIS 1 and OASIS 2 trials, an integrated analysis of the OASIS trials focused on ABSSSI shows omadacycline effectiveness, safety, and tolerability.
Why this matters
- The FDA approved omadacycline for CAPB and ABSSSI in early October.
- The company said in a statement that omadacycline is the first and only once-daily intravenous and oral antibiotic approved for both conditions in almost 20 years.
- The company expects it to be available in first quarter 2019.
- In the efficacy trials that involved molecularly characterized pathogens, 87.5% (14/16) of those treated with omadacycline in OPTIC and 100% (5/5) in the OASIS studies had clinical success.
- The involved pathogen was Streptococcus pneumoniae.
- Staphylococcus aureus and Escherichia coli were involved in indeterminate clinical response cases.
- One Klebsiella pneumoniae case involved clinical failure.
- In the integrated analysis, omadacycline performed similarly to comparator linezolid against S aureus (including methicillin-resistant S aureus), Streptococcus pyogenes, and Streptococcus anginosus.
- Adverse event (AEs) rates were similar between the 2 (51% with omadacycline; 41% with linezolid).
- Most frequent AEs related to treatment were nausea and vomiting.
- The efficacy trial evaluated Gram-positive and Gram-negative isolates (24 and 17 samples, respectively): 26 from OPTIC, 10 from OASIS 1, and 5 from OASIS 2.
- The integrated analysis involved data from OASIS 1 and OASIS 2 (oral only), with early clinical response compared between study drug and linezolid.
- Funding: Paretek Pharmaceuticals.
- Small sample numbers for efficacy study.
- Conference presentation; not peer-reviewed.