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Paratek Pharmaceuticals Announces Phase I Trial of PTK 0796, a New Broad-Spectrum Antibiotic

Posted on: Thursday, 28 July 2005, 09:00 CDT

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/.

Paratek Pharmaceuticals, Inc.

CONTACT: Investor Relations, Kate Boxmeyer of Paratek Pharmaceuticals,Inc., +1-617-275-0040 ext. 238, kboxmeyer@paratekpharm.com; Media Relations,Justin Jackson, +1-212-213-0006, jjackson@burnsmc.com, for ParatekPharmaceuticals, Inc.

Web site: http://www.paratekpharm.com/

Source: PRNewswire

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