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SAN DIEGO, Sept. 17, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), today provided updates on the potential broad-spectrum, in vitro activity for omadacycline. Across seven microbiology studies omadacycline demonstrated in vitro activity against Gram-positive, Gram-negative, and atypical bacteria, including those with resistance to currently available antibiotics. The data are being presented at the joint meeting of the International Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) in San Diego, September 17 - 21. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. Omadacycline, Paratek's lead clinical candidate, is a once-daily oral and intravenous (IV), broad-spectrum antibiotic currently in Phase 3 development.
The breadth of data from microbiology testing of omadacycline demonstrated that the compound offers potential novel therapeutic value against Staphylococcus aureus, Streptococcus pneumoniae, [including resistant strains], and Enterobacteriaceae compared to commonly prescribed antibiotics. Additional in vitro data suggest that omadacycline may be useful in infections caused by Legionella pneumophilia lending support to the compound's potential utility as an oral and IV monotherapy agent for the treatment of community-acquired bacterial pneumonia (CABP).
"Data from the microbiology studies presented this week reinforce omadacycline's in vitro activity against pathogens important in our target indications, " said Evan Loh, M.D., Paratek's President and Chief Medical Officer. "Given the potential breadth of microbiologic in vitro coverage demonstrated in these studies by omadacycline, the favorable clinical tolerability profile we've seen to date, and the convenient and bioequivalent once-daily oral and IV formulations, we believe omadacycline has potential to be developed for clinical use as a monotherapy treatment option for serious community-acquired infections where resistance is of concern. "
Select Study Results: Activity Against S. aureus
Select Study Results: Activity Against S. pneumoniae
Select Study Results: Activity Against Enterobacteriaceae
Select Study Results for In Vitro Testing
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, is a first-in-class aminomethylcycline, derived from tetracyclines. Paratek has initiated a Phase 3 registration trial in ABSSSI to determine the efficacy and safety of omadacycline compared to linezolid. A second Phase 3 registration trial in CABP to determine the efficacy and safety of omadacycline compared to moxifloxacin is planned to be initiated before the end of 2015.
Omadacycline is a first-in-class once-daily oral and intravenous, broad-spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections (ABSSSI), community acquired bacterial pneumonia (CABP), urinary tract infections (UTI), and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.
Paratek's second product candidate, sarecycline, also known as WC 3035, is a first-in-class once-daily oral tetracycline-derived compound, designed to provide both a narrow-spectrum of antibiotic activity and favorable tolerability profile, for the treatment of acne and rosacea in the community setting. Paratek has licensed rights to sarecycline for the treatment of acne in the United States to a subsidiary of Allergan, formerly Warner Chilcott, while retaining development and commercialization rights in the rest of the world. Allergan is responsible for the clinical development of sarecycline for the treatment of acne in the United States. A Phase 3 program was initiated by Allergan in December 2014 for sarecycline for the treatment of moderate to severe inflammatory acne.
For more information, visit www.paratekpharm.com.
Forward Looking Statements
The statements in this press release regarding the potential utility of omadacycline as an oral and IV monotherapy agent for the treatment of CABP, Paratek's belief that omadacycline has potential to be developed for clinical use as a monotherapy treatment option for serious community-acquired infections where resistance is of concern, and the planned timing of a second Phase 3 registration trial in CABP with omadacycline, are forward-looking statements. These forward-looking statements are based upon Paratek's current expectations and involve substantial risks and uncertainties. Paratek may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in these forward-looking statements and investors should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to (i) Paratek's need for substantial additional funding to complete the development and commercialization of omadacycline, (ii) Paratek's ability to raise the capital to do so, (iii) risks that data to date and trends may not be predictive of future results, (iv) risks related to the conduct of Paratek's clinical trials, and (v) risks that Paratek's clinical trials and product candidates do not receive regulatory approval. These and other risk factors are discussed under "Risk Factors" and elsewhere in Paratek's Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, and Paratek's other filings with the Securities and Exchange Commission. Paratek expressly disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein.
CONTACT: Media Relations: Michael Lampe (484) 575-5040 firstname.lastname@example.org Investor Relations: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568