2014

Paratek Pharmaceuticals Announces Phase I Trial of PTK 0796, a New Broad-Spectrum Antibiotic Paratek Plans to Initiate Phase I Trial of Oral Version in 2006; A New Drug to

Treat Community MRSA



    BOSTON, July 28 /PRNewswire/ -- Paratek Pharmaceuticals, Inc. announced
 today that the Company is conducting a Phase I clinical trial of its lead
 compound from a new class of antibiotics called aminomethylcyclines (AMCs),
 derived from the well-known tetracycline family.  PTK 0796 is a novel,
 broad-spectrum antibiotic that has been shown to be highly effective in animal
 models at treating clinically prevalent infections caused by Gram-positive,
 Gram-negative, atypical and anaerobic bacteria, including those with
 multi-drug resistance.  The compound is the first in the AMC class to enter
 clinical development.
     Thomas J. Bigger, President and CEO of Paratek Pharmaceuticals, stated,
 "This is Paratek's first drug trial in human subjects and an important
 milestone for the Company's antibiotic development programs.  We expect that
 the trial, which is taking place in the United Kingdom, will be completed
 within the next several months, and that PTK 0796 will prove to be safe and
 well-tolerated.  Based on this timeline, studies in the United States in
 hospitalized patients with serious, life-threatening infections could begin by
 spring of next year."
     The Phase I study is designed to measure safety and tolerability of the
 intravenous (IV) formulation of PTK 0796 in healthy subjects.  Stuart B. Levy,
 M.D., Co-founder and Chief Scientific Officer of Paratek Pharmaceuticals,
 explained, "Bacterial infections in hospitals are becoming increasingly
 difficult to treat, in large part because of rising bacterial resistance.
 Newer agents that are active against newly emerging and multi-drug resistant
 infectious disease agents are urgently needed."
     Dr. Levy continued, "In preclinical studies, PTK 0796 has been shown to be
 highly effective in more than 20 disease models and to work equally well
 against susceptible and resistant organisms.  Based on the preclinical
 results, we expect that PTK 0796 will prove to be safe and well-tolerated in
 the ongoing trial.  The preclinical program has also shown that PTK 0796 is
 orally absorbed, which would allow for clinical testing of an oral formulation
 of the drug to help treat multi-drug resistant bacterial infections in the
 community.  These include community-acquired methicillin-resistant
 Staphylococcus aureus (MRSA) and other pathogens, like resistant pneumococci
 that cause pneumonia.  Infections such as MRSA are a growing concern.  We are
 completing the final preclinical tests necessary to begin a Phase I clinical
 trial of the oral formulation in 2006."
     MRSA, recognized as primarily a grave problem in the hospital setting, now
 threatens people in the community.  The Centers for Disease Control (CDC) has
 seen the emergence and spread of a more virulent form of MRSA in the
 community, causing skin infections and deaths.  At a time when large
 pharmaceutical companies have left the antibiotic discovery area, Paratek
 represents the dedication and commitment of smaller biopharmaceutical
 companies to address the acute need for new antibiotics.
 
     Program Background
     Selected from the novel group of AMC antibiotics discovered by Paratek,
 PTK 0796 has demonstrated promising activity against a wide range of clinical
 bacterial isolates, including those resistant to currently available classes
 of antibiotics and known to cause diseases such as pneumonias, urinary tract
 infections, skin diseases and blood-borne infections.  PTK 0796 is not
 affected by resistance to other classes of antibiotics.
     AMCs were evolved from tetracycline antibiotics employing Paratek's novel
 medicinal chemistry techniques as potential agents to combat multiple
 antibiotic resistant bacteria, including MRSA, penicillin-resistant
 Streptococcus pneumoniae (PRSP), and vancomycin-resistant Enterococcus (VRE).
 Introduced more than 50 years ago, tetracyclines were among the most commonly
 used anti-infective agents to combat bacterial infections.  However, the
 emergence of resistance has sharply curtailed their effectiveness.  Paratek
 believes that the ability to create new classes of compounds based upon the
 core tetracycline structure will yield a diversity of novel, more effective,
 clinically useful products that may be used as first-line treatments.
 
     About Paratek Pharmaceuticals
     Paratek Pharmaceuticals, Inc. is engaged in the discovery and
 commercialization of new therapeutics that treat serious and life-threatening
 diseases, with a particular focus on the growing worldwide problem of
 antibiotic resistance. Paratek's lead programs are advancing novel compounds
 that can circumvent or block bacterial resistance such as the AMCs, as well as
 small molecule drugs that can prevent infection by interfering with Multiple
 Adaptational Response (MAR) mechanisms in bacteria.
     Outside the antibacterial therapeutic area, Paratek has also established
 an effort to exploit its novel tetracycline derivatives and their unique
 mechanism of action in selected anti-inflammatory and neurodegenerative
 conditions.  Paratek has an active chemical synthesis effort to produce novel
 and diverse small molecules, with the goal of developing non-antibacterial
 compounds with improved activity in serious inflammatory and neurodegenerative
 diseases based upon a growing body of clinical and basic research supporting
 this approach.
     Paratek is privately held and headquartered in Boston, Massachusetts, USA.
 For more information, visit Paratek's website at http://www.paratekpharm.com/.
 
 

SOURCE Paratek Pharmaceuticals, Inc.

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