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Paratek Presents Pre-Clinical Data on the Effects of Omadacycline on Clostridium Difficile
“Broad spectrum antibiotics have important therapeutic value, but they also have the potential to increase a patient’s risk for superinfection, such as C. difficile. When selecting antibiotic therapy, it’s important to consider this risk and take steps to minimize it,” said
Antibiotic use is a well-known risk factor for C. difficile infection. Risk of infection has historically been low in patients treated with tetracyclines.1,2 Omadacycline is the first in a new generation of tetracyclines known as the aminomethylcyclines.
In vitro Study Results
The antimicrobial omadacycline was introduced to gut microbiota which were stable prior to exposure (Poster #P1324). Omadacycline was shown to disrupt microflora populations, with declines in populations of clostridia (~6 log10 cfu/mL), bifidobacteria (~6 log10 cfu/mL), B. fragilis group species (~3 log10 cfu/mL) Lactobaccilus spp. (~2 log10 cfu/mL) and Enterococcus spp. (~4 log10 cfu/mL) observed. Omadacycline did not disrupt the overall population of Enterobacteriaceae. Despite these changes, no evidence of C. difficile germination, vegetative cell proliferation or toxin production was observed, in contrast to other antimicrobials previously evaluated using this model.
To evaluate the microbiological activity of omadacycline in vitro and animal model testing was conducted (Poster #P1325). Omadacycline was tested in vitro against 27 clinical isolates of C. difficile using broth and agar microdilution methods. The MIC90 for omadacycline against C. difficile was 0.06 mg/L by broth dilution and 0.12 mg/L by agar dilution. Additional results showed omadacycline to be more active against C. difficile than doxycycline (MIC90 = 0.5 mg/L by broth and 1 mg/L by agar).
Using animal models to determine efficacy of omadacycline against C. difficile infection, hamsters were pretreated with clindamycin (10 mg/kg) 24 hours prior to infection. Post infection, hamsters were dosed orally with omadacycline (50/mg/kg/day), vancomycin (50 mg/kg/day) or vehicle (sterile water) for five days. The median survival for omadacycline-treated animals was 12 days compared to 2 days for vancomycin and 4 days for clindamycin pre-treatment.
About Clostridium Difficile (C. difficile)
Clostridium difficile (C. difficile) is a bacterium that causes life-threatening diarrhea. People who have other illnesses or conditions requiring prolonged use of antibiotics, and the elderly, are at greater risk of infection. Often, infections occur in hospitalized or recently hospitalized patients or nursing home residents.
The bacterium is shed in feces. Any surface, device, or material that becomes contaminated with feces may serve as a reservoir for the C. difficile spores. C. difficile spores are transferred to patients mainly via the hands of healthcare personnel who have touched a contaminated surface or item. C. difficile can live for long periods on surfaces.4
In 2013, the CDC classified C. difficile infection as an urgent, drug-resistant threat to the U.S.5
Omadacycline is a new once-daily oral and IV, well-tolerated broad-spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community acquired bacterial pneumonia, urinary tract infections (UTI), and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.
Paratek's second Phase 3 product candidate, sarecycline, is designed to be a well-tolerated, once daily, oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting.
For more information, visit www.paratekpharma.com.
Forward Looking Statement
Certain statements in this press release, including statements regarding the projected availability of top-line data from Paratek's Phase 3 clinical trials of omadacycline and the expected benefits of Paratek's product candidates are forward-looking statements. These forward-looking statements are based upon Paratek's current expectations and involve substantial risks and uncertainties. Paratek may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in these forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to (i) unexpected results that may cause the designs of the clinical trials to change, or the projected timelines of the trials to be extended, (ii) unexpected decline in the rates of patient enrollment in the clinical trials, (iii) unforeseen adverse effects experienced by patients resulting in a clinical hold, (iv) failure of patients to complete clinical trials, (v) risks related to regulatory oversight of the trials, (vi) the need for substantial additional funding to complete the development and commercialization of product candidates and (vii) risks that data to date and trends may not be predictive of future results. These and other risk factors are discussed under "Risk Factors" and elsewhere in Paratek's Annual Report on Form 10-K for the year ended
1 Baxter, R. et al “Antibiotic Use and Subsequent Clostridium Difficile Infection: A Case Control Study” ICAAC 2006; K-349.
2 Doernberg, SB. Et al “Does doxycycline protect against development of Clostridium difficile infection?” Clin Infect Dis. 2012 Sep;55(5):615-20. doi: 10.1093/cid/cis457. Epub 2012
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