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Antibacterials
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
being developed for first-line use in serious infections occurring
in the hospital and community setting, including those caused by multi-drug
resistant (MDR) bacteria such as 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
(such as CABP) and other infections requiring hospitalization. PTK 0796 has been administered in two randomized,
evaluator-blinded complicated skin and skin structure infection (cSSSI) clinical studies in >350 patients.
Patients in these studies were treated with IV and oral step-down therapy compared to Zyvox®.
PTK 0796 demonstrated excellent safety, tolerability and efficacy in these studies with very good clinical
success rates (both at the traditional Test of Cure endpoint and at the more recently FDA-espoused
early response timepoint). It should also be noted that in the studies more than 50% of the infecting bacteria
were MRSA. Phase 3 ABSSSI studies have
been agreed to under a signed Special Protocol Assessment (SPA) with the FDA, and moderate to severe
community acquired bacterial pneumonia (CABP) studies are planned to start soon. Paratek has presented
preclinical and clinical data on PTK
0796 at a number of conferences in recent years.
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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 lead candidate has been designated, IND-enabling preclinical
studies have been completed and Phase 1 clinical trials are underway.
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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.
Another program is focused on developing a narrow-spectrum tetracycline for animal health, specifically
targeting the bacteria involved in bovine and porcine respiratory diseases. Paratek is exploring
the targeted application of its tetracycline derived compounds for these and other indications.
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