VIENNA, Austria, April 25, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) today presented new
data from a Phase 1 study confirming that its once-daily oral and IV, broad spectrum investigational antibiotic omadacycline
effectively penetrates lung tissue and epithelial lining fluid and has a broad antimicrobial activity against those bacteria most
commonly associated with community-acquired bacterial pneumonia (CABP). Data from a second Phase 1 study evaluating the safety of
omadacycline compared to tigecycline reported no serious adverse events following IV treatment with either compound and reported
that omadacycline was associated with a lower incidence of gastrointestinal adverse events compared to tigecycline. The new
findings were presented at the annual meeting of the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID
2017) in Vienna, Austria.
“Intravenous dosing of omadacycline at 100 mg produced steady-state concentrations in the plasma, epithelial lining
fluid (ELF), and alveolar cells (AC) that were three-fold higher than tigecycline in healthy subjects. Our observed lung
concentrations along with the minimum inhibitory concentration values for respiratory pathogens support the recent results of
omadacycline being as effective as moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia,” said
Keith Rodvold, Pharm.D., professor in the College of Pharmacy, Co-Director of the Section of Infectious Diseases Pharmacotherapy at
University of Illinois at Chicago.
“Throughout our clinical development program, we have worked to generate a thorough understanding of all aspects of
omadacycline and share that information with the scientific and clinical community,” said Evan Loh, M.D., President, Chief
Operating Officer and Chief Medical Officer, Paratek. “These data add to the growing body of evidence to support omadacycline as an
effective agent in the treatment of serious acquired bacterial infections, particularly where resistance is of concern to
prescribing physicians.”
Phase 1 Bronchoalveolar Lavage Study
The Phase 1 PK/PD study compared serial plasma concentrations of omadacycline and tigecycline in healthy adults.
Subjects receiving omadacycline (n=41) received 100 mg IV every 12 hours for 2 doses then 100 mg IV once-daily; subjects in the
tigecycline arm (n=17) received a 100 mg IV loading dose followed by 50 mg IV every 12 hours. To assess the concentration of both
omadacycline and tigecycline in epithelial lining fluid (ELF) and alveolar macrophages (AM), bronchoalveolar lavage (BAL) was
performed on all subjects.
The AUC0-24/MIC90 ratios for omadacycline were greater than tigecycline across all
measurements. Specific results showed omadacycline plasma ratios to be 3.2-fold higher (97.8 vs. 30.8) for S. pneumoniae
and MSSA and 1.5-fold higher (46.9 vs. 30.8) for MRSA. The AUC0-24/MIC90 ratios in the ELF were 2.7-fold
higher for omadacycline (143.6 vs. 52.7) for S. pneumoniae and MSSA and 1.3-fold higher (68.9 vs. 52. 7) for MRSA. AM
ratios for L. pneumophila were 126-fold higher for omadacycline.
Phase 1 Safety and Tolerability Study
In an open-label safety study presented yesterday, 63 healthy adults were randomized to omadacycline (n=42) or
tigecycline (n=21). Dosing was similar to the PK/PD study and treatment duration was four days with a follow up assessment
conducted 7 to 14 days after the final dose. Treatment emergent adverse events were mild-to-moderate in both groups and included
headache, nosebleed (epistaxis), nausea, decreased appetite and vomiting. Fewer individuals in the omadacycline group reported
gastrointestinal adverse event. There were two discontinuations in the tigecycline group due to nausea that were considered related
to study drug. No omadacycline subjects discontinued study treatment due to adverse events.
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
the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive,
Gram-negative and atypical bacteria. Omadacycline is a new, 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, community-acquired bacterial pneumonia, urinary tract infections, and other
community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing
physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S.
Food and Drug Administration for the target indications.
In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and
skin structure infections (ABSSSI) demonstrating the efficacy, general safety and tolerability of intravenous (IV) to once-daily
oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration
study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy, general safety and tolerability of IV to
once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing
of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. Top-line data from this study are
expected as early as the end of June. The Company plans to submit its new drug application (NDA) in the U.S. as early as the
first quarter of 2018 with an EMA submission later in 2018.
In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections
(UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans
to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of
complicated urinary tract infections, as early as December 2017.
In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore
the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance
including plague and anthrax.
Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum
tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the
community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all
ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for
the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the
U.S. in the second half of 2017.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product
candidates, clinical studies, prospects and expected results, including statements about the timing of advancing omadacycline and
otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and of our reporting of the results of
such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from
ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing
broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline. All statements, other than statements of
historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing,"
"believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning.
These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may
not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking
statements and you should not place undue reliance on these forward-looking statements. Our 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. These
and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended
December 31, 2016, and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or
undertaking to update or revise any forward-looking statements contained herein.
CONTACTS: Media Relations: Michael Lampe (484) 575-5040 michael@scientpr.com Investor Relations: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568
