Omadacyclineomadacycline, omadacycline structure
Omadacycline formerly known as PTK-0796 is a broad spectrum antibiotic belonging to the aminomethylcycline subclass of tetracycline antibiotics Paratek Pharmaceuticals is developing omadacycline as a treatment for certain serious community-acquired infections and was invented at Tufts University School of Medicine by Drs Mark L Nelson and Mohamed Ismail while at Tufts and Laura Honeyman at Paratek Pharmaceuticals, Boston Nelson and his chemistry team created over 3000 new derivatives of the tetracyclines using novel methods of chemistry applied to the tetracycline family of compounds
- 1 In vitro studies
- 2 Mechanism of action
- 3 Clinical trials
- 4 References
In vitro studies
In vitro studies have shown that omadacycline has activity against a broad range of Gram-positive and select Gram-negative pathogens Omadacycline has potent in vitro activity against Gram-positive aerobic bacteria including methicillin-resistant Staphylococcus aureus MRSA, pencillin-resistant and multi-drug resistant Streptococcus pneumoniae, and vancomycin-resistant Enterococcus Omadacycline also has antimicrobial activity against common Gram-negative aerobes, some anaerobes, and atypical bacteria such as Legionella and Chlamydia This activity translated to potent efficacy for omadacycline in an in vivo systemic infection model in mice
Additional in vitro and in vivo studies of omadacycline metabolism, disposition, and drug interactions show that omadacycline is metabolically stable ie, it does not undergo significant biotransformation and neither inhibits nor interacts with metabolizing enzymes or transporters
Mechanism of action
The mechanism of action of omadacycline is similar to that of other tetracyclines – inhibition of bacterial protein synthesis Omadacycline has activity against bacterial strains expressing the two main forms of tetracycline resistance efflux and ribosomal protection
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 Patients were randomized at 11 sites in the US 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 The results indicated that omadacycline is well-tolerated and has the potential to be an effective treatment in patients with complicated skin and skin structure infections
In June 2013, the US Food and Drug Administration FDA designated the intravenous and oral formulations of omadacycline as a qualified infectious disease product in the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia
A 650 patient phase 3 registration study comparing omadacycline to linezolid for the treatment of acute bacterial skin and skin structure infections began in June 2015 Omadacycline met the primary efficacy endpoint of early clinical response with statistical non-inferiority 10% margin compared to linezolid, and was generally safe and well-tolerated The most common treatment-emergent adverse events were gastrointestinal side effects 180% for omadacycline vs 158% for linezolid
A 750 patient phase 3 study comparing omadacycline to moxifloxacin for the treatment of community-acquired bacterial pneumonia began in November 2015 Omadacycline was statistically non-inferior to moxifloxacin at the early clinical response, 72 to 120 hours after therapy was initiated
In May 2016, a phase 1b study of omadacycline in urinary tract infection was initiated
In August 2016, a second phase 3 study of omadacycline was initiated in patients with acute bacterial skin and skin structure infections, comparing the efficacy and safety of once-daily, oral omadacycline to that of twice-daily, oral linezolid In July 2017, analysis of the data showed that all of the primary and secondary endpoints required for submission to the FDA and EMA were met This was the third phase 3 registration study of omadacycline with favorable results
- ^ Boggs, Jennifer "Antibiotic Firm Paratek Joins IPO Queue; Aiming for $92M" bioworldcom Clarivate Analytics Retrieved October 17, 2017
- ^ Honeyman, Laura; Ismail, Mohamed; Nelson, Mark L; Bhatia, Beena; Bowser, Todd E; Chen, Jackson; Mechiche, Rachid; Ohemeng, Kwasi; Verma, Atul K; Cannon, E Pat; MacOne, Ann; Tanaka, S Ken; Levy, Stuart 2015 "Structure-Activity Relationship of the Aminomethylcyclines and the Discovery of Omadacycline" Antimicrobial Agents and Chemotherapy 59 11: 7044–7053 doi:101128/AAC01536-15 PMC 4604364 PMID 26349824
- ^ Tanaka, S Ken 20 June 2016 "In Vitro and In Vivo Assessment of Cardiovascular Effects with Omadacycline" Antimicrobial Agents and Chemotherapy 60 9: 5247–53 doi:101128/AAC00320-16 PMC 4997885 PMID 27324778
- ^ Villano, Stephen 19 August 2016 "Omadacycline: development of a novel aminomethylcycline antibiotic for treating drug-resistant bacterial infections" Future Microbiology 11: 1421–1434 doi:102217/fmb-2016-0100 Retrieved 24 August 2016
- ^ MacOne, A B; Caruso, B K; Leahy, R G; Donatelli, J; Weir, S; Draper, M P; Tanaka, S K; Levy, S B February 2014 "In Vitro and in Vivo Antibacterial Activities of Omadacycline, a Novel Aminomethylcycline" Antimicrobial Agents and Chemotherapy 58 2: 1127–1135 doi:101128/AAC01242-13 PMC 3910882 PMID 24295985
- ^ Flarakos, Jimmy 8 August 2016 "Clinical disposition, metabolism and in vitro drug–drug interaction properties of omadacycline" Xenobiotica: 1–15 doi:101080/0049825420161213465
- ^ Draper, M P; Weir, S; MacOne, A; Donatelli, J; Trieber, C A; Tanaka, S K; Levy, S B March 2014 "Mechanism of Action of the Novel Aminomethylcycline Antibiotic Omadacycline" Antimicrobial Agents and Chemotherapy 58 3: 1279–1283 doi:101128/AAC01066-13 PMC 3957880 PMID 24041885
- ^ Noel, G J; Draper, M P; Hait, H; Tanaka, S K; Arbeit, R D November 2012 "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" Antimicrobial Agents and Chemotherapy 56 11: 5650–5654 doi:101128/AAC00948-12 PMC 3486554 PMID 22908151
- ^ "Paratek Pharmaceuticals Announces FDA Grant of Qualified Infectious Disease Product QIDP Designation for Its Lead Product Candidate, Omadacycline" prnewsirecom PR Newswire January 3, 2013 Retrieved October 17, 2017
- ^ Seiffert, Don 2015 "Paratek presents new trial data for antibiotic as late-stage trials continue" bizjournalscom American City Business Journals Retrieved October 17, 2017
- ^ "Omadacycline Versus Linezolid for the Treatment of ABSSSI EudraCT #2013-003644-23" clinicaltrialsgov Retrieved 2015-10-13
- ^ "Paratek Announces that Omadacycline Met All Primary and Secondary Efficacy Outcomes Designated by FDA and EMA in a Phase 3 Study in Acute Bacterial Skin Infections; Omadacycline was Generally Safe and Well-Tolerated" financeyahoocom Retrieved 3 July 2016
- ^ "Omadacycline vs Moxifloxacin for the Treatment of CABP EudraCT #2013-004071-13" clinicaltrialsgov Retrieved 2015-10-13
- ^ "Paratek Announces Positive Phase 3 Study of Omadacycline in Community-Acquired Bacterial Pneumonia" wwwglobenewswirecom April 3, 2017 Retrieved 16 May 2017
- ^ "Paratek Initiates Phase 1b Study of Omadacycline in Urinary Tract Infection" globenewswirecom May 2, 2016 Retrieved 3 July 2016
- ^ "Paratek Initiates Phase 3 Study of Oral-only Omadacycline in ABSSSI" globenewswirecom August 15, 2016 Retrieved 15 August 2016
- ^ "Paratek Announces Phase 3 Study of Oral-Only Dosing of Omadacycline Met All Primary and Secondary FDA and EMA Efficacy Endpoints in Acute Bacterial Skin Infections" wwwglobenewswirecom July 17, 2017 Retrieved 19 July 2017
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