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Paratek Pharmaceuticals, Inc.

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Paratek Advances Timing of Top-Line Data for Phase 3 Community Acquired Bacterial Pneumonia Study to the Second Quarter of 2017

BOSTON, Dec. 13, 2016 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, announced today that it projects its ongoing pivotal Phase 3 clinical study evaluating omadacycline for the treatment of community acquired bacterial pneumonia (CABP) will report top-line data during the second quarter of 2017. The company had previously estimated that this trial would report top-line data as early as the third quarter of 2017. The revised estimate reflects faster-than-expected patient enrollment in the study. This study, which is designed to assess the efficacy and safety of IV to once-daily oral omadacycline compared with moxifloxacin in subjects with CABP, enrolled its first patient in November 2015.
“We’ve been very pleased with the progress of this study, and this new projected timeline further reinforces our expectation that, with a successful outcome, we will be able to file a new drug application for omadacycline for both the acute skin infections and pneumonia indications in the first half of 2018,” said Evan Loh, M.D., President and Chief Medical Officer, Paratek. “Omadacycline offers a unique option for physicians as an IV to once-daily oral, broad spectrum antibiotic with a well characterized safety and tolerability profile. Our recently announced positive clinical bronchoalveolar lavage pharmacokinetic data, together with our pre-clinical data, and microbiological data, further supports our confidence in omadacycline as a potential treatment for community acquired bacterial pneumonia.”
This Phase 3, randomized, double-blind, multi-center study will compare the safety and efficacy of intravenous (IV) to oral (PO) omadacycline therapy to moxifloxacin IV/PO for treating adults with CABP. The study is designed to enroll approximately 750 adult subjects in approximately 125 centers worldwide. The primary efficacy endpoint for FDA evaluation as established in the protocol is defined as the number of subjects with clinical success at the early clinical response assessment visit 72-120 hours after the first dose of study drug. Other secondary efficacy outcome measurements will include investigator assessment of clinical response, overall survival and resolution or improvement of signs and symptoms at the post treatment evaluation visit (5-10 days after the last day of therapy). In addition, safety and tolerability as assessed by treatment-emergent adverse events, vital sign measurements, ECGs, and laboratory values will be measured.
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Source: press release, 12/13/16. http://investor.paratekpharm.com/phoenix.zhtml?c=253770&p=irol-newsArtic...

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The second ongoing study in our Phase 3 registration program is for the treatment of community-acquired bacterial pneumonia. We are pleased to report that enrollment of this study is currently ahead of our initial projections; as such we are now expecting top-line data from this study as early as the third quarter of 2017,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “We are also pleased to report that we have now initiated our Phase 1b study with omadacycline for the treatment of urinary tract infections.”
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Source: press release, 5/02/16. http://investor.paratekpharma.com/phoenix.zhtml?c=253770&p=irol-newsArti...

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Paratek Initiates Omadacycline Phase 3 Clinical Study in Community Acquired Bacterial Pneumonia (CABP)

Dosing initiated in second of two Phase 3 registration studies for Paratek's omadacycline

Phase 3 program designed to support approval in two indications: acute bacterial skin and skin structure infections and community acquired bacterial pneumonia

BOSTON, Nov. 9, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) today announced the dosing of the first patient in its Phase 3 clinical study of its lead drug candidate, omadacycline, for the treatment of Community Acquired Bacterial Pneumonia (CABP). This global Phase 3 study will assess the efficacy and safety of omadacycline compared with moxifloxacin in subjects with CABP.

Omadacycline is the first in a new class of tetracyclines known as aminomethylcyclines. It is being developed as a once-daily oral and IV therapy to treat serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern. Omadacycline is designed with mechanisms to circumvent the two clinically important mechanisms of bacterial resistance seen with prior generations of tetracycline derivatives. Data from omadacycline microbiology and clinical studies to date show that it has the potential to offer broad-spectrum coverage against Gram-positive, Gram-negative and atypical bacteria, and it has demonstrated activity against a variety of resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus. pneumoniae (PRSP), macrolide-resistant Streptococcus pneumoniae, vancomycin-resistant enterococcus (VRE) and other bacteria that are resistant to older generation tetracycline antibiotics and other classes of antibiotics.

The CABP study is the second of two planned Phase 3 registration studies of omadacycline. Top-line data from this pivotal study is projected to be available in the second half of 2017. A Phase 3 trial in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) began enrolling patients in June of this year with top-line data projected to be available in the second half of 2016.

"The initiation of our second Phase 3 registration study this year is a significant milestone for Paratek," said Michael Bigham, Chairman and Chief Executive Officer. "Antibiotic resistance is a significant healthcare challenge that requires novel treatment options. We believe omadacycline has the potential to become an important therapeutic option for serious community acquired bacterial infections, particularly when antibiotic resistance is a concern."

"Dosing of this first patient in our pivotal Phase 3 study for Community Acquired Bacterial Pneumonia Infections is another important step forward in Paratek's commitment to bring omadacycline to patients with serious respiratory and skin infections," said Evan Loh, M.D., President and Chief Medical Officer.

About the Phase 3 Study of Omadacycline in CABP

This Phase 3, randomized, double-blind, multi-center study will compare the safety and efficacy of intravenous (IV) to oral (PO) omadacycline therapy to moxifloxacin IV/PO for treating adults with CABP. The study is designed to enroll approximately 750 adult subjects in approximately 150 centers worldwide. The primary efficacy endpoint for FDA evaluation as established in the protocol is defined as the number of subjects with clinical success at the early clinical response assessment visit 72-120 hours after the first dose of study drug. Other efficacy outcome measurements will include investigator assessment of clinical response, overall survival and resolution or improvement of signs and symptoms at the post treatment evaluation visit (5-10 days after the last day of therapy). In addition, safety and tolerability as assessed by treatment-emergent adverse events, vital sign measurements, ECGs, and laboratory values will be measured.
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Source: press release, 11/09/15. http://investor.paratekpharm.com/phoenix.zhtml?c=253770&p=irol-newsArtic...

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A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia
Estimated Enrollment: 750
Study Start Date: November 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT02531438?term=Omadacycline&rank=1

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Omadacycline (PTK796) CABPInfectious DiseaseCommunity acquired pneumonia (CAP)AminomethylcyclineBacterial ribosome

Mechanism of action: Omadacycline (PTK796) is an aminomethylcycline, a semisynthetic derivative of minocycline that has in vitro potency against Gram-positive and Gram-negative bacteria. Omadacycline binds to the 70S bacterial ribosome and acts as an inhibitor of protein synthesis.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2017-04-01 - 2017-06-30

Results: Pending