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
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.
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
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.