Omadacycline
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| ChemSpider | 20131003 |
| Jmol 3D model | Interactive image |
| PubChem | 54697325 |
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| Except where otherwise noted, data are given for materials in their standard state (at 25 °C [77 °F], 100 kPa). | |
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Omadacycline (formerly known as PTK-0796)[1] is a broad spectrum antibiotic belonging to the aminomethylcycline subclass[2] of tetracycline antibiotics. Paratek Pharmaceuticals, Inc. is developing omadacycline as a treatment for serious community-acquired infections.
In vitro studies have shown that omadacycline has activity against a broad range of Gram-positive and select Gram-negative pathogens. This activity translated to potent efficacy for omadacycline in an In vivo systemic infection model in mice.[3]
The mechanism of action for omadacycline has been shown to be primarily through inhibition of bacterial protein synthesis. Omadacycline has demonstrated activity against bacterial strains expressing the two main forms of tetracycline resistance (efflux and ribosomal protection).[4]
A Phase 2 study was conducted comparing the safety and efficacy of omadacycline to linezolid for the treatment of complicated skin and skin structure infections (cSSSI). Patients were randomized to receive either omadacycline 100 mg intravenously once daily with an option to transition to 200 mg orally once daily or linezolid 600 mg intravenously twice daily with an option to transition to 600 mg orally twice daily at 11 US sites. The phase 2 trial results support conclusions that omadacycline is well tolerated in cSSSI patients and has the potential to be an effective treatment for serious skin infections.[5]
In June 2013, the US Food and Drug Administration (FDA) designated omadacycline as a Qualified Infectious Disease Product (QIDP) for both intravenous and oral formulations in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).[6]
A 650 patient Phase 3 study comparing omadacycline to linezolid for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) began in June 2015.[7][8] A 750 patient Phase 3 study comparing omadacycline to moxifloxacin for the treatment of Community Acquired Bacterial Pneumonia (CABP) began in November 2015.[9]
References
- ↑ http://www.bioworld.com/content/antibiotic-firm-paratek-joins-ipo-queue-aiming-92m-0
- ↑ Honeyman L., Structure Activity Relationship of the Aminomethylcyclines and the Discovery of Omadacycline, Antimicrob Agents Chemother. 2015 Nov;59(11):7044-53.doi: 10.1128/AAC.01536-15. Epub 2015 Sep 8.
- ↑ Marcone A.B., In vitro and in vivo antibacterial activities of omadacycline, a novel aminomethylcycline, Antimicrob Agents Chemother. 2014;58(2):1127-35. doi: 10.1128/AAC.01242-13. Epub 2013 Dec 2.
- ↑ Draper MP, Mechanism of action of the novel aminomethylcycline antibiotic omadacycline, Antimicrob Agents Chemother. 2014;58(3):1279-83. doi: 10.1128/AAC.01066-13. Epub 2013 Sep 16.
- ↑ Noel GJ, A randomized, evaluator-blind, phase 2 study comparing the safety and efficacy of omadacycline to those of linezolid for treatment of complicated skin and skin structure infections, Antimicrob Agents Chemother. 2012 Nov;56(11):5650-4. doi: 10.1128/AAC.00948-12. Epub 2012 Aug 20.
- ↑ http://www.prnewswire.com/news-releases/paratek-pharmaceuticals-announces-fda-grant-of-qualified-infectious-disease-product-qidp-designation-for-its-lead-product-candidate-omadacycline-185554432.html
- ↑ http://www.bizjournals.com/boston/blog/bioflash/2016/04/paratek-presents-new-trial-data-for-antibiotic-as.html
- ↑ "Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23) - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2015-10-13.
- ↑ "Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13) - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2015-10-13.