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Anti-Bacterials
Paratek's lead drug candidates are proprietary new chemical
entities (NCEs) that overcome important multi-drug resistant bacteria in the
hospital and community treatment settings:
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PTK 0796 - the most advanced compound from a new class called
the aminomethylcyclines (AMC), derived from the tetracyclines. PTK 0796 is a
broad spectrum antibiotic being developed for first-line use in hospital
infections, including serious infections and those caused by multi-drug
resistant (MDR) bacteria, including methicillin-resistant Staphylococcus aureus
(MRSA). As a once-daily oral and IV antibiotic agent with activity against a
broad spectrum of resistant and susceptible bacteria, PTK 0796 offers
flexibility as an empiric monotherapy for treatment of important infections of
the skin and respiratory tract such as complicated skin infections, pneumonias
and other infections requiring hospitalization. In December 2007, PTK 0796
completed a randomized, evaluator-blinded >200 patient Phase 2 complicated
skin and skin structure infection (cSSSI) clinical study with IV and oral
step-down therapy compared to Zyvox®. PTK 0796 demonstrated excellent safety,
tolerability and efficacy in this study with very good clinical success rates
and a very favorable safety profile. It should also be noted that in the study
more than 50% of the infecting bacteria were MRSA. Phase 3 studies in cSSSI and
moderate to severe community acquired pneumonia (CAP) are planned to start in
2008. Paratek has presented preclinical data
on PTK 0796 at a number of conferences in recent years.
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Community-Targeted Antibiotics
- Paratek is also developing a group of tetracycline-derived antibiotic
compounds for first-line use primarily in community settings where resistant
bacteria are also an increasing problem. Preclinical testing is underway and an
oral community antibacterial agent is anticipated to enter Phase 1 later in
2008.
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Acne - Tetracyclines are well-established in the treatment of
moderate to severe acne, where they are the most widely prescribed systemic
therapy. Potent antibacterial activity against P. acnes
bacteria and anti-inflammatory activity are believed to make tetracyclines
considerably more active than other systemic antibiotics in the treatment of
acne. Paratek is developing novel targeted-spectrum antibacterial tetracyclines
with improved anti-inflammatory activity and tolerability as next generation
agents for acne. These compounds would have a limited spectrum of antibacterial
activity and may have utility for the treatment of rosacea and other
inflammation associated dermatologic diseases as well. A number of lead
candidates have been identified, and preclinical studies are underway in
anticipation of starting Phase 1 clinical trials.
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Targeted Antibiotics - a next generation application of
Paratek’s tetracycline antibacterial technology is the development of targeted
compounds to address emerging needs in a variety of settings. Paratek is
working on developing a narrow-spectrum non-absorbed tetracycline derivative
for use in treating C. difficile Associated Diarrheal (CDAD) infections,
which due to increasing resistance and use of broad-spectrum antibiotics have
become a serious problem in many hospital settings. Paratek is exploring the
targeted application of its tetracycline derived compounds for this and other
indications.
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