Paratek Pharmaceuticals, Inc. Reports Third Quarter 2016 Financial Results And Provides Clinical Updates

  • Successfully demonstrated proof-of-principle in a Phase 1b study of oral and IV omadacycline in patients with urinary tract infections (UTI)
  • Completed all clinical phase 1 studies and registration batches required for NDA submission
  • Company to Host an R&D Day on November 17 in New York City
  • Conference call scheduled for 8:30 a.m. EDT on November 2, 2016

BOSTON, Nov. 02, 2016 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today reported financial results for the quarter ended September 30, 2016. The company also reported the completion and top-line results of a Phase 1b study of omadacycline in patients with urinary tract infections, as well as the completion of several important clinical and manufacturing requirements for its planned NDA submission.

Phase 1b UTI Pharmacokinetic Results In this clinical study, patients with uncomplicated UTI received either IV-to-oral or oral-only regimens of omadacycline over a period of five days. Results showed that omadacycline achieved high steady state concentrations in urine for all treatment regimens, demonstrating proof-of-principle for the use of omadacycline in UTI.

Clinical & Manufacturing NDA Registration Requirements The company completed two required Phase 1 pharmacokinetic studies to support the planned regulatory filings for omadacycline.

The first of the two Phase 1 studies assessed the concentration of omadacycline in the lungs via bronchoalveolar lavage (BAL).  This study, conducted in healthy volunteer subjects, demonstrated that omadacycline is able to penetrate into the lungs and epithelial lining fluid, at concentrations higher than plasma.  The second Phase 1 study evaluated exposure levels of omadacycline in patients with end-stage renal disease. This study found that in these patients, omadacycline had similar pharmacokinetic exposure profiles to healthy subjects, suggesting that omadacycline can be used in subjects with renal impairment without the need for dose adjustments.

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